Showing posts with label Abbott. Show all posts
Showing posts with label Abbott. Show all posts
Thursday, August 08, 2013
Thursday, September 23, 2010
Thursday, January 21, 2010
Reductil (sibutramine) pulled from the EU market
The anti-obesity drug sibutramine has had its licence suspended by the European authorities due to concerns over an increased risk of cardiovascular events with the treatment.The Medicines and Healthcare products Regulatory Agency announced today that a European-wide review had concluded the risk of heart attacks and strokes from sibutramine (Reductil) outweighs the benefit gained from weight loss.
NHS data show GPs issued over 330,000 prescriptions for sibutramine in 2008, but GPs have been advised not to issue any new prescriptions for sibutramine and to review the treatment of any patients taking the drug.
Both the European Medicines Agency and the US Food and Drug Administration announced reviews into sibutramine last December after a study found an excess of serious cardiovascular events in high-risk patients on the treatment.
Dr June Raine, director of vigilance and risk management of medicines at the MHRA said: 'Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.
'Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatment of patients taking the drug.
Wednesday, January 28, 2009
Abbott - Vicodin CR: evergreen fail
Abbott Laboratories fired 200 sales representatives preparing to market Vicodin CR (Continued Revenue) after the company stopped plans to introduce the drug this year, people familiar with the matter said.
The drugmaker said in October that the drug, an extended release form of Vicodin, failed to gain U.S. Food and Drug Administration approval. The company hasn’t released details of the so-called complete response letter from the FDA.
More at Bloomberg
The drugmaker said in October that the drug, an extended release form of Vicodin, failed to gain U.S. Food and Drug Administration approval. The company hasn’t released details of the so-called complete response letter from the FDA.
More at Bloomberg
Thursday, December 04, 2008
Abbott - Xience: safety first!
Abbott Laboratories said it will embed safety information about its Xience heart device into a YouTube video spot, a disclosure made hours after a consumer group complained the spots ran afoul of U.S. Food and Drug Administration rules on product marketing.
"Abbott's practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information," Abbott said in a statement to the Tribune on Wednesday, adding that it had done nothing wrong. "All Abbott's Xience V videos on YouTube were posted in July 2008 with prominent links to the 'Brief Summary of Instructions for Use,' which details the product's risk and safety information. To avoid any problems in the future, we will embed safety and risk information in the videos moving forward."
The Boston-based Prescription Project, long a critic of drug and medical device industry marketing, said Wednesday that such videos should be regulated by the FDA and include safety warnings like other health industry products marketed in other venues.
Thursday, August 14, 2008
AstraZeneca - Crestor: making hay
The British drugmaker is going to jointly promote Crestor with Abbott Labs in the US, a noteworthy reversal of AstraZeneca’s solo strategy up until now.
More
More
Sunday, May 11, 2008
Abbott - Norvir: some weekend reading
Back in April, we at the Prescription Access Litigation (PAL) blog asked “What is Abbott trying to hide?” in a blog post about drugmaker Abbott Laboratories’ efforts to keep documents from reaching the public in a class action lawsuit challenging Abbott’s unconscionable 400% price hike for its HIV/AIDS drug Norvir.
I’m pleased to report that the Court in that case recently ordered that some of the documents be made available to the public.
PAL have just posted those documents in their entirety on the PAL blog, in an entry titled “What Abbott was Trying to Hide - Court unseals Norvir documents.”
I’m pleased to report that the Court in that case recently ordered that some of the documents be made available to the public.
PAL have just posted those documents in their entirety on the PAL blog, in an entry titled “What Abbott was Trying to Hide - Court unseals Norvir documents.”
Friday, April 11, 2008
Abbott - any volunteers for Phase 3?
Abbott has seen "no signals of lung cancer" in patient trials of its experimental inhaled insulin, a company spokesman said Thursday.
Abbott's disclosure comes a day after Pfizer Inc. (PFE) warned that a small number of users of its inhaled insulin, Exubera, developed lung cancer, though it wasn't able to determine whether Exubera was the cause. Pfizer decided last year to stop marketing Exubera due to disappointing market performance since it was approved in 2006; the company is working with doctors to switch patients from Exubera to other therapies.
Abbott inherited an early-stage inhaled-insulin development program when it acquired Kos Pharmaceutical in 2006. The product is in the middle stage, or Phase 2, of human testing.
"We've seen no signals of lung cancer in our trials," Abbott spokesman Kurt Ebenhoch told Dow Jones Newswires Thursday.
More
Insider's view: Well, that's all ok then.
Must just be an Exubera problem!
So.....
Volunteers for the large Phase 3 studies please form an orderly line!!
Abbott's disclosure comes a day after Pfizer Inc. (PFE) warned that a small number of users of its inhaled insulin, Exubera, developed lung cancer, though it wasn't able to determine whether Exubera was the cause. Pfizer decided last year to stop marketing Exubera due to disappointing market performance since it was approved in 2006; the company is working with doctors to switch patients from Exubera to other therapies.
Abbott inherited an early-stage inhaled-insulin development program when it acquired Kos Pharmaceutical in 2006. The product is in the middle stage, or Phase 2, of human testing.
"We've seen no signals of lung cancer in our trials," Abbott spokesman Kurt Ebenhoch told Dow Jones Newswires Thursday.
More
Insider's view: Well, that's all ok then.
Must just be an Exubera problem!
So.....
Volunteers for the large Phase 3 studies please form an orderly line!!
Friday, April 04, 2008
PAL ask "What is Abbott trying to hide?"
What is Abbott trying to hide? Maker of Norvir asks Court to deny public the right to see documents
April 3rd, 2008
In December 2003, Abbott Laboratories (NYSE: ABT) decided to increase the price of its HIV/AIDS drug Norvir (ritonavir) by 400%. PAL member Service Employees International Union Health & Welfare Fund filed a class action lawsuit against Abbott in October 2004, alleging that the price increase violated the antitrust laws.
Norvir is a “protease inhibitor” (PI) that is commonly used as part of AIDS “drug cocktails” (combinations of prescription drugs working together). Norvir is very important because it “boosts” the effects of other PIs taken by HIV/AIDS patients. Abbott, by increasing the cost of Norvir by 400%, effectively forced HIV/AIDS patients to pay significantly more for their life-saving drug regimens. (The Wall Street Journal did an excellent story in Jan. 2007 laying out the history of the price increase, “Inside Abbott’s tactics to protect AIDS drug“)
Abbott faced a firestorm of criticism for this outrageous price increase — there were shareholder resolutions, protests at Abbott headquarters, a boycott by hundreds of physicians, Attorney General investigations, numerous newspaper editorials lambasting the move, etc. But Abbott refused to even consider reducing the price. The only significant challenge to Abbott’s conduct is the lawsuit brought by SEIU Health and Welfare Fund and two patients.
The lawsuit has overcome significant hurdles (the Court denied Abbott’s motion to dismiss and motion for Summary Judgment, and certified the case as a class action), and the trial is scheduled to begin this summer. Abbott has again filed a motion for Summary Judgment. Such motions are filed with the Court after the parties have completed discovery (exchange of documents, depositions of witnesses and experts) but before the trial. Abbott is essentially asking the Judge to rule in its favor, arguing that based on the evidence, there’s no way a reasonable jury could find in favor of the plaintiffs.
Both Abbott and the plaintiffs have filed numerous documents with their Summary Judgment motions, and now Abbott is asking the Court to “seal” many of those documents, i.e. make them not available to the public. The motions and papers concerning Abbott’s request are here, here and here.
Why does Abbott want to keep these documents a secret and out of public view?
One of Abbott’s lawyers submitted a declaration to the Court giving the reasons:
“5. It is my understanding that the portions that have been redacted reflect, in general, Abbott’s strategic thinking and views related to pricing, public relations, marketing, research and development, market positioning, promotional activities, market segmentation, strategic brainstorming, long-range planning, sales, and lifecycle management of its pharmaceutical products that are not shared with the public or widely disseminated even within Abbott. It is my understanding that this information is kept in the highest confidence even within Abbott and is not intended to be disseminated to the general public or Abbott’s competitors.”
It seems to me that “Abbott’s strategic thinking and views related to pricing, public relations, marketing, research and development, market positioning, promotional activities, market segmentation,” etc are all of great public interest, particularly given that they concern a drug that is essential to fighting the significant public health crisis that is HIV/AIDS.
The fact that such information “is not intended to be disseminated to the general public” of course doesn’t mean that it shouldn’t be. In fact, it may even be all the more reason it should be.
In fact, the plaintiffs quoted a Court opinion from an unrelated case in their original filing on this issue:
“Indeed, common sense tells us that the greater the motivation a corporation has to shield its operations, the greater the public’s need to know.” [In re Lifescan, Inc. Consumer Litigation, No. C 98 20321 JF, 1999 U.S. Dist. LEXIS 9894, at ** 7-8 (N.D. Cal. June 23, 1999)]
But let’s read on…
“6. In addition, it is my understanding that many of the Exhibits, from which these redactions are made, contain information that could be confusing, misleading, or incomplete if taken out of context or without the proper background information. Therefore, some of the information redacted, in addition to being competitively sensitive, could be used to mislead the public and be perceived in a way that was never intended by the author or the deponent. Public dissemination of this information could substantially harm Abbott’s good will, standing, and relationships that it has created with the HIV/AIDS community.”
Of course, one has to ask, what good will, standing, and relationships with the HIV/AIDS community is Abbott talking about? Abbott managed to alienate virtually the entire HIV/AIDS community by raising Norvir’s price, and then further by threatening to withhold all new medicines from Thailand if Thailand’s government issued a compulsory license for the HIV/AIDS drug Kaletra (a pill that, incidentally contains Norvir, and which the Norvir price hike was intended to increase US sales of). [A compulsory license would have allowed Thailand to break the patent on Kaletra in Thailand and import a less costly generic version]
And how could Abbott think that trying to keep these documents from public view would improve its relationship with the HIV/AIDS community? It’s likely that many of the documents would just rehash what’s already publicly known about Abbott’s reprehensible price increase.
Sometimes trying to keep documents secret does more harm to a company’s reputation than the documents themselves would have. Nothing arouses suspicion more than the question “What are they trying to hide?”
So Abbott may have, as the expression goes, cut off its nose to spite its face with this move.
Abbott’s attorney then goes on to give “justifications” for why particular Exhibits should be sealed, all beginning with the phrase “It is my understanding that…”
The lawyers for SEIU and the class filed a response to Abbott’s attorneys arguments, which is here. They point out that:
To have documents sealed, Abbott has to “overcome a strong presumption of access by showing that ‘compelling reasons supported by specific factual findings . . . outweigh the general history of access and the public policies favoring disclosure.’” Pintos v. Pac. Creditors Ass’n, 504 F.3d 792, 802 (9th Cir. 2007).
“The declaration Abbott has filed in support of its sealing request… fails to satisfy Abbott’s burden…[T]he declaration is not based on the personal knowledge of Abbott’s counsel…For the most part, the declaration merely asserts [Abbott’s counsel’s] “understanding” of the general subject matter of the redacted portions of the documents Abbott proposes that the Court permanently seal, and presents no actual evidence.”
The “Declaration offers little in the way of facts; rather, it is replete with unsubstantiated, conclusory statements and hypothetical assertions, as well as argument… Abbott has not even attempted to make the sort of particularized showing mandated by the applicable standards.
And finally, “much of the information in the documents has already been made public, the documents are mostly four to six years old and therefore especially undeserving of being shielded and there is a particularly strong interest here in allowing public access to the materials at issue given that the subject matter of the litigation ‘involves matters of significant public concern.’”
So we ask you, dear readers, what do you think?
Did Abbott do more harm than good in trying to seal these documents? Post your thoughts in the comments.
To receive udpates about the Norvir case, fill out the form located here.
For information about the Norvir case, including copies of court documents, go here.
April 3rd, 2008
In December 2003, Abbott Laboratories (NYSE: ABT) decided to increase the price of its HIV/AIDS drug Norvir (ritonavir) by 400%. PAL member Service Employees International Union Health & Welfare Fund filed a class action lawsuit against Abbott in October 2004, alleging that the price increase violated the antitrust laws.
Norvir is a “protease inhibitor” (PI) that is commonly used as part of AIDS “drug cocktails” (combinations of prescription drugs working together). Norvir is very important because it “boosts” the effects of other PIs taken by HIV/AIDS patients. Abbott, by increasing the cost of Norvir by 400%, effectively forced HIV/AIDS patients to pay significantly more for their life-saving drug regimens. (The Wall Street Journal did an excellent story in Jan. 2007 laying out the history of the price increase, “Inside Abbott’s tactics to protect AIDS drug“)
Abbott faced a firestorm of criticism for this outrageous price increase — there were shareholder resolutions, protests at Abbott headquarters, a boycott by hundreds of physicians, Attorney General investigations, numerous newspaper editorials lambasting the move, etc. But Abbott refused to even consider reducing the price. The only significant challenge to Abbott’s conduct is the lawsuit brought by SEIU Health and Welfare Fund and two patients.
The lawsuit has overcome significant hurdles (the Court denied Abbott’s motion to dismiss and motion for Summary Judgment, and certified the case as a class action), and the trial is scheduled to begin this summer. Abbott has again filed a motion for Summary Judgment. Such motions are filed with the Court after the parties have completed discovery (exchange of documents, depositions of witnesses and experts) but before the trial. Abbott is essentially asking the Judge to rule in its favor, arguing that based on the evidence, there’s no way a reasonable jury could find in favor of the plaintiffs.
Both Abbott and the plaintiffs have filed numerous documents with their Summary Judgment motions, and now Abbott is asking the Court to “seal” many of those documents, i.e. make them not available to the public. The motions and papers concerning Abbott’s request are here, here and here.
Why does Abbott want to keep these documents a secret and out of public view?
One of Abbott’s lawyers submitted a declaration to the Court giving the reasons:
“5. It is my understanding that the portions that have been redacted reflect, in general, Abbott’s strategic thinking and views related to pricing, public relations, marketing, research and development, market positioning, promotional activities, market segmentation, strategic brainstorming, long-range planning, sales, and lifecycle management of its pharmaceutical products that are not shared with the public or widely disseminated even within Abbott. It is my understanding that this information is kept in the highest confidence even within Abbott and is not intended to be disseminated to the general public or Abbott’s competitors.”
It seems to me that “Abbott’s strategic thinking and views related to pricing, public relations, marketing, research and development, market positioning, promotional activities, market segmentation,” etc are all of great public interest, particularly given that they concern a drug that is essential to fighting the significant public health crisis that is HIV/AIDS.
The fact that such information “is not intended to be disseminated to the general public” of course doesn’t mean that it shouldn’t be. In fact, it may even be all the more reason it should be.
In fact, the plaintiffs quoted a Court opinion from an unrelated case in their original filing on this issue:
“Indeed, common sense tells us that the greater the motivation a corporation has to shield its operations, the greater the public’s need to know.” [In re Lifescan, Inc. Consumer Litigation, No. C 98 20321 JF, 1999 U.S. Dist. LEXIS 9894, at ** 7-8 (N.D. Cal. June 23, 1999)]
But let’s read on…
“6. In addition, it is my understanding that many of the Exhibits, from which these redactions are made, contain information that could be confusing, misleading, or incomplete if taken out of context or without the proper background information. Therefore, some of the information redacted, in addition to being competitively sensitive, could be used to mislead the public and be perceived in a way that was never intended by the author or the deponent. Public dissemination of this information could substantially harm Abbott’s good will, standing, and relationships that it has created with the HIV/AIDS community.”
Of course, one has to ask, what good will, standing, and relationships with the HIV/AIDS community is Abbott talking about? Abbott managed to alienate virtually the entire HIV/AIDS community by raising Norvir’s price, and then further by threatening to withhold all new medicines from Thailand if Thailand’s government issued a compulsory license for the HIV/AIDS drug Kaletra (a pill that, incidentally contains Norvir, and which the Norvir price hike was intended to increase US sales of). [A compulsory license would have allowed Thailand to break the patent on Kaletra in Thailand and import a less costly generic version]
And how could Abbott think that trying to keep these documents from public view would improve its relationship with the HIV/AIDS community? It’s likely that many of the documents would just rehash what’s already publicly known about Abbott’s reprehensible price increase.
Sometimes trying to keep documents secret does more harm to a company’s reputation than the documents themselves would have. Nothing arouses suspicion more than the question “What are they trying to hide?”
So Abbott may have, as the expression goes, cut off its nose to spite its face with this move.
Abbott’s attorney then goes on to give “justifications” for why particular Exhibits should be sealed, all beginning with the phrase “It is my understanding that…”
The lawyers for SEIU and the class filed a response to Abbott’s attorneys arguments, which is here. They point out that:
To have documents sealed, Abbott has to “overcome a strong presumption of access by showing that ‘compelling reasons supported by specific factual findings . . . outweigh the general history of access and the public policies favoring disclosure.’” Pintos v. Pac. Creditors Ass’n, 504 F.3d 792, 802 (9th Cir. 2007).
“The declaration Abbott has filed in support of its sealing request… fails to satisfy Abbott’s burden…[T]he declaration is not based on the personal knowledge of Abbott’s counsel…For the most part, the declaration merely asserts [Abbott’s counsel’s] “understanding” of the general subject matter of the redacted portions of the documents Abbott proposes that the Court permanently seal, and presents no actual evidence.”
The “Declaration offers little in the way of facts; rather, it is replete with unsubstantiated, conclusory statements and hypothetical assertions, as well as argument… Abbott has not even attempted to make the sort of particularized showing mandated by the applicable standards.
And finally, “much of the information in the documents has already been made public, the documents are mostly four to six years old and therefore especially undeserving of being shielded and there is a particularly strong interest here in allowing public access to the materials at issue given that the subject matter of the litigation ‘involves matters of significant public concern.’”
So we ask you, dear readers, what do you think?
Did Abbott do more harm than good in trying to seal these documents? Post your thoughts in the comments.
To receive udpates about the Norvir case, fill out the form located here.
For information about the Norvir case, including copies of court documents, go here.
Wednesday, March 19, 2008
TAP to split
Abbott Laboratories disclosed late Wednesday that it has agreed to with Japanese partner Takeda Pharmaceuticals to split up their decades-old drug-making joint venture, TAP Pharmaceuticals.
Takeda, Japan's biggest drug producer, has long been interested in taking full control of the venture, which the two companies formed in 1977. But the two partners have reportedly had difficulty in the past settling on a buyout price.
Under the accord the two companies announced today, they will "evenly divide the value" of the joint venture.
More at the Trib
Takeda, Japan's biggest drug producer, has long been interested in taking full control of the venture, which the two companies formed in 1977. But the two partners have reportedly had difficulty in the past settling on a buyout price.
Under the accord the two companies announced today, they will "evenly divide the value" of the joint venture.
More at the Trib
Tip top TAP
Takeda, Japan's largest drug maker, plans to buy out Abbott's stake in their 50-50 U.S. joint venture, TAP, for 500 billion yen ($5 billion), a source close to the deal said on Wednesday.
Reuters
Now what might Abbott want the cash for? What with all the pharma companies trading at near 52 week lows an' all.
Reuters
Now what might Abbott want the cash for? What with all the pharma companies trading at near 52 week lows an' all.
Tuesday, March 18, 2008
Abbott - TriCor: see you in court
Eighteen states are suing North Chicago-based Abbott Laboratories, alleging the drug maker blocked generic competition for a popular cholesterol medication.
The federal antitrust lawsuit charges that Abbott and an unidentified French drug company (Fournier?) tried to block competition for a cheaper, generic version of the prescription drug TriCor. The cholesterol drug accounted for more than $1 billion of Abbott's sales last year.
The states allege that the companies continuously made minor changes in the formulations of TriCor to prevent generic versions from entering the market.
The Trib
The federal antitrust lawsuit charges that Abbott and an unidentified French drug company (Fournier?) tried to block competition for a cheaper, generic version of the prescription drug TriCor. The cholesterol drug accounted for more than $1 billion of Abbott's sales last year.
The states allege that the companies continuously made minor changes in the formulations of TriCor to prevent generic versions from entering the market.
The Trib
Roche - Xenical: jailed ex-Abbott rep was their best customer
Back story here.
The Medicines and Healthcare products Regulatory Agency has successfully prosecuted Robin Huxley (age, 45) from Barnsley and Stephen Pownall (age, 45), Newark, Notts, on Friday 14 March 2008 at Sheffield Crown Court for the illegal sale and supply of medicines, Reductil and Xenical.
On the 28 November 2007 Mr. Huxley pleaded guilty to five counts under the Medicines Act 1968 at Sheffield Crown Court and subsequently was sentenced to fourteen months imprisonment.
Stephen Pownall was ordered to pay a total of £7497.80 in fines, confiscation and costs.
From May 2001 to 31 March 2005 Mr. Huxley was employed in the pharmaceutical industry, where he used his knowledge and expertise to obtain large quantities of prescription only medicines namely Reductil. (Which is usually prescribed for clinical obesity.)
He also obtained large amounts of Xenical from Roche Pharmaceuticals Ltd.
He then went on to sell these products in his various slimming and weight loss clinics, based in Barnsley, without any of his clients having been given a prescription or an appropriate medical consultation.
Source
The Medicines and Healthcare products Regulatory Agency has successfully prosecuted Robin Huxley (age, 45) from Barnsley and Stephen Pownall (age, 45), Newark, Notts, on Friday 14 March 2008 at Sheffield Crown Court for the illegal sale and supply of medicines, Reductil and Xenical.
On the 28 November 2007 Mr. Huxley pleaded guilty to five counts under the Medicines Act 1968 at Sheffield Crown Court and subsequently was sentenced to fourteen months imprisonment.
Stephen Pownall was ordered to pay a total of £7497.80 in fines, confiscation and costs.
From May 2001 to 31 March 2005 Mr. Huxley was employed in the pharmaceutical industry, where he used his knowledge and expertise to obtain large quantities of prescription only medicines namely Reductil. (Which is usually prescribed for clinical obesity.)
He also obtained large amounts of Xenical from Roche Pharmaceuticals Ltd.
He then went on to sell these products in his various slimming and weight loss clinics, based in Barnsley, without any of his clients having been given a prescription or an appropriate medical consultation.
Source
Hat tip: Jimmie
Monday, April 16, 2007
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