Merck said yesterday that is corrected the study that led to the withdrawal of Vioxx, but that it didn't change the results of the the Approve Study.
Merck said this does not change the Approve results: That use of Vioxx increased the risk of blood clot-related heart attacks after 18 months of continuous treatment.
The source of this article is from Money.com, which you can read by going here.
Wednesday, May 31, 2006
Tuesday, May 30, 2006
Celebrex Case Continued
The case set for trial in State Court in Alabama that was set for June of 2006 has been continued. It has not been reset.
More later.
More later.
Friday, May 26, 2006
Memorial Day Off Topic: Do You Run?
Happy Memorial Day weekend to all. For me, Memorial Day means taking my mind off of legal and the office, and it also means four days of running, in addition to honoring those who served. I prefer trail running which can not always be the easiest thing to do in Atlanta, GA.
On long weekends, I spend time running in a NPS forest known as Sope Creek. This is a trail that has from 3 to 12 miles of tree shaded running and cycling. The lower portion of the trail is loaded with daily runner and walkers. On any given weekend, you may see 500 of more people using the area most call "Columns Drive" or simply "The River." Once you leave the lower trails, it may be that you see 1 or 2 people at most.
Pics of what I see each time are below. I've seen an eagle, wild turkeys, a fox (I think) and it's all just about 30 minutes from where I live. There's a family cemetery deep in the forest that has headstones from the 1850's. Water crossings, mud and silence are parts of each run.
I'll post pics later this weekend.
If you're a runner and have a favorite place to unwind after a day riding the wave of paper on your desk, tell me about it.
On long weekends, I spend time running in a NPS forest known as Sope Creek. This is a trail that has from 3 to 12 miles of tree shaded running and cycling. The lower portion of the trail is loaded with daily runner and walkers. On any given weekend, you may see 500 of more people using the area most call "Columns Drive" or simply "The River." Once you leave the lower trails, it may be that you see 1 or 2 people at most.
Pics of what I see each time are below. I've seen an eagle, wild turkeys, a fox (I think) and it's all just about 30 minutes from where I live. There's a family cemetery deep in the forest that has headstones from the 1850's. Water crossings, mud and silence are parts of each run.
I'll post pics later this weekend.
If you're a runner and have a favorite place to unwind after a day riding the wave of paper on your desk, tell me about it.
An End to Fen Phen ?
Drug maker Wyeth is ready to distribute nearly $1.3 billion to nearly 40,000 people who took Fen Phen. Some know that the fund is called the 7th Amendment fund, which covers various claimants After appeals were completed, fund became final this month.
Funds should be paid out through the fall.
My firm has been investigating and litigating Fen Phen claims since 2000. For those that heard about the litigation, I commend to your reading a book titled "Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen" which you of course can find at Amazon.com
It's a fast read, compelling and shocking.
Funds should be paid out through the fall.
My firm has been investigating and litigating Fen Phen claims since 2000. For those that heard about the litigation, I commend to your reading a book titled "Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen" which you of course can find at Amazon.com
It's a fast read, compelling and shocking.
Wednesday, May 24, 2006
Bone and Tissue Scandal: MDL Hearing 5/25/06
The JPML will hear argument on 5/25 in Kansas City, Missouri regarding Regeneration Technologies Inc.'s MDL Petition. RTI would like to establish an MDL in New Jersey and have approximately a half dozen cases transferred.
Several will argue that the infected bone and tissue cases filed and to be filed should be addressed in an MDL in South Florida.
You can expect other states to be presented during this hearing. I am opposed to an MDL at this juncture in the investigation and litigation of the scandal, but see it down the road.
Most infected bone and tissue claims may likely be made in New York given the information obtained to date, but you may see claims from Minnesota, Oklahoma, Wahsington and Texas as the scandal continues.
For more information go to www.bonescandal.com
Several will argue that the infected bone and tissue cases filed and to be filed should be addressed in an MDL in South Florida.
You can expect other states to be presented during this hearing. I am opposed to an MDL at this juncture in the investigation and litigation of the scandal, but see it down the road.
Most infected bone and tissue claims may likely be made in New York given the information obtained to date, but you may see claims from Minnesota, Oklahoma, Wahsington and Texas as the scandal continues.
For more information go to www.bonescandal.com
Motion to Limit Qualification of Jurors
This just worked for me. Needless to say Defense counsel was not happy. I have filed this Motion in the last half dozen cases, and a Judge just ruled in my favor:
PLAINTIFF’S MOTION TO LIMIT QUALIFICATION OF JURORS
Plaintiff files the following Motion and states:
Plaintiff respectfully requests that the Court, during the course of the questioning of any veniremen, prohibit the Defendant or the Court itself from asking any potential juror if he or she can be “fair” in deliberations of the pending matter.
Plaintiff submits that a venireman cannot be the judge of his or her own fairness. Asking a juror a question of whether or not he/she is “fair” will in each instance result in a “yes” answer. Insistence upon asking a venireman such a question will ultimately result in the denial of an opportunity to exercise a challenge for cause, if such an issue arises. The use of a “fairness” question will thus result in the denial of a right to trial by jury of one’s peers. Curry v. State, 336 S.E.2d 762 (Ga. 1985).
**I don't use any other cases, and argue common sense. If anyone else uses it and has success with it, please let me know.
PLAINTIFF’S MOTION TO LIMIT QUALIFICATION OF JURORS
Plaintiff files the following Motion and states:
Plaintiff respectfully requests that the Court, during the course of the questioning of any veniremen, prohibit the Defendant or the Court itself from asking any potential juror if he or she can be “fair” in deliberations of the pending matter.
Plaintiff submits that a venireman cannot be the judge of his or her own fairness. Asking a juror a question of whether or not he/she is “fair” will in each instance result in a “yes” answer. Insistence upon asking a venireman such a question will ultimately result in the denial of an opportunity to exercise a challenge for cause, if such an issue arises. The use of a “fairness” question will thus result in the denial of a right to trial by jury of one’s peers. Curry v. State, 336 S.E.2d 762 (Ga. 1985).
**I don't use any other cases, and argue common sense. If anyone else uses it and has success with it, please let me know.
Benzene: News Regarding Additional Defendants
Coca-Cola and Cadbury Schweppes are set to be sued in Florida regarding allegations that several of drinks created by each may have contained benzene, fiften years after they pledged to fix the problem.
The Florida lawsuit clainms that independent lab tests found Fanta Orange Pineapple contaminated with benzene at 4.7 times the five parts per billion limit for benzene in USA's drinking water.
The Florida lawsuit says that the companies should have known about the potential for benzene to form in drinks containing benzoates and Vitamin C.
Benzene exposure has serious health effects. Breathing very high levels of benzene can result in death, while high levels can cause drowsiness, dizziness, rapid heart rate, headaches, tremors, confusion, and unconsciousness. Eating or drinking foods containing high levels of benzene can cause vomiting, irritation of the stomach, dizziness, sleepiness, convulsions, rapid heart rate, and death.
The major effect of benzene from chronic (long-term) exposure is to the blood. Benzene damages the bone marrow and can cause a decrease in red blood cells, leading to anemia. It can also cause excessive bleeding and depress the immune system, increasing the chance of infection. {See Wikipedia, here}
Read more here.
The Florida lawsuit clainms that independent lab tests found Fanta Orange Pineapple contaminated with benzene at 4.7 times the five parts per billion limit for benzene in USA's drinking water.
The Florida lawsuit says that the companies should have known about the potential for benzene to form in drinks containing benzoates and Vitamin C.
Benzene exposure has serious health effects. Breathing very high levels of benzene can result in death, while high levels can cause drowsiness, dizziness, rapid heart rate, headaches, tremors, confusion, and unconsciousness. Eating or drinking foods containing high levels of benzene can cause vomiting, irritation of the stomach, dizziness, sleepiness, convulsions, rapid heart rate, and death.
The major effect of benzene from chronic (long-term) exposure is to the blood. Benzene damages the bone marrow and can cause a decrease in red blood cells, leading to anemia. It can also cause excessive bleeding and depress the immune system, increasing the chance of infection. {See Wikipedia, here}
Read more here.
Tuesday, May 23, 2006
Do NSAIDs Lead to Heart Failure?
Nonsteroidal anti-inflammatories (NSAIDs) may be associated with a thirty percent increased risk in older patients of first hospital admission for heart failure, a U.K. study reported in the journal Heart.
NSAIDs are used to treat pain in many types of medical conditions. Several NSAIDs are available without a doctor's prescription ("over the counter" or OTC medications). These include aspirin, low dose (200 mg) ibuprofen (Advil, Motrin, Nuprin,), and low dose naproxen (Aleve). Most claim that NSAIS are safe medications for the vast majority of patients taking them in appropriate doses. Other NSAIDs are only available with a doctor's prescription.
The study of people aged 60 to 84 found that a previous diagnosis of (1)obesity, 2)heart failure (3)cigarette smoking history, and (3)A history of recent in-patient stays and specialist appointments, were tied to an increase in the likelihood of admission to a hospital for heart failure for the first time. The time frame covered was a four year period.
According to the study, of those admitted to any medical facility fourteen percent took one or more NSAIDs upon admission to any facility. This compared with ten percent of a comparison group of randomly selected people. Nearly fifty percent of those who checked in to any hospital were between the ages of 70 to 79.
Of all the NSAIDs, indomethacin (indocin) was associated with an allegedly higher risk. Those who took that drug were three times more likely to be admitted to hospital than people who did not take indomethacin. Osteoarthritis was the most common reason why people took NSAIDs.
Those who wrote the study stated that for every 1,000 people aged 60 to 84 who took any NSAID one extra first hospital admission for heart failure was found.
The study also found that there may be an increase of three additional cases per 1,000 people among patients aged 70 and older with conditions such as diabetes, high blood pressure or kidney failure.
You can read more from this source: Here.
NSAIDs are used to treat pain in many types of medical conditions. Several NSAIDs are available without a doctor's prescription ("over the counter" or OTC medications). These include aspirin, low dose (200 mg) ibuprofen (Advil, Motrin, Nuprin,), and low dose naproxen (Aleve). Most claim that NSAIS are safe medications for the vast majority of patients taking them in appropriate doses. Other NSAIDs are only available with a doctor's prescription.
The study of people aged 60 to 84 found that a previous diagnosis of (1)obesity, 2)heart failure (3)cigarette smoking history, and (3)A history of recent in-patient stays and specialist appointments, were tied to an increase in the likelihood of admission to a hospital for heart failure for the first time. The time frame covered was a four year period.
According to the study, of those admitted to any medical facility fourteen percent took one or more NSAIDs upon admission to any facility. This compared with ten percent of a comparison group of randomly selected people. Nearly fifty percent of those who checked in to any hospital were between the ages of 70 to 79.
Of all the NSAIDs, indomethacin (indocin) was associated with an allegedly higher risk. Those who took that drug were three times more likely to be admitted to hospital than people who did not take indomethacin. Osteoarthritis was the most common reason why people took NSAIDs.
Those who wrote the study stated that for every 1,000 people aged 60 to 84 who took any NSAID one extra first hospital admission for heart failure was found.
The study also found that there may be an increase of three additional cases per 1,000 people among patients aged 70 and older with conditions such as diabetes, high blood pressure or kidney failure.
You can read more from this source: Here.
NYT Article on Vioxx and Why The Data Differs
It's worth signing up for the New York Times to read the recent weekend article regarding the data recently released. The article is titled, "Vioxx Data Suggest Risks Started Earlier."
I posted on that subject last week, which you can read here.
I posted on that subject last week, which you can read here.
Monday, May 22, 2006
Contaminated Bone and Tissue Update
From New York, to Austin, Texas, to Atlanta, GA the scandal continues.
A key figure in this scandal is Dr. Michael Mastromarino, who was a New Jersey oral surgeon who agreed in 2002 to the suspension of his license to practice dentistry in New York state. Four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.
Here is what we have learned form the FDA records and state records, open to all:
*The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.
* New York State requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.
* Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.
The FDA also issued findings in late January that indicated:
*Eight cases where company records included false statements about a donor's age or cause of death;
*There cases in which the records misstated where tissue recovery was done;
*Six cases where BTS did not disclose that a donor had been hospitalized;and
*Two cases that listed a fictitious spouse on a consent form;
A key figure in this scandal is Dr. Michael Mastromarino, who was a New Jersey oral surgeon who agreed in 2002 to the suspension of his license to practice dentistry in New York state. Four days later, the New York state Department of Health granted him licenses to operate human tissue banks in Brooklyn. Mastromarino also registered his company with the U.S. Food and Drug Administration.
Here is what we have learned form the FDA records and state records, open to all:
*The FDA does not conduct background checks on owners or operators of tissue banks, nor does it lay out any minimum qualifications or standards.
* New York State requires tissue bank applicants to provide information about their background, including arrests and professional misconduct, and requires the Health Department to consider the "character and competence" of bank owners and operators. But Matromarino did not disclose his problems and state officials did not check.
* Regulators conducted no inspections of Biomedical's facility during its first year and inspections afterwards failed to detect practices that regulators now allege were fraudulent and unsafe.
The FDA also issued findings in late January that indicated:
*Eight cases where company records included false statements about a donor's age or cause of death;
*There cases in which the records misstated where tissue recovery was done;
*Six cases where BTS did not disclose that a donor had been hospitalized;and
*Two cases that listed a fictitious spouse on a consent form;
Sereboff: Additional Information as to this decision
The comments below are from the SCOTUS blog:
Counsel for Sereboff argued that Knudson imposed a strict “tracing requirement” on all recoveries – i.e., that the funds the plan sought to recover must be directly traceable to those the plan had advanced.
Justice Roberts, however, distinguished between an “equitable lien sought as a matter of restitution” and an “equitable lien imposed by agreement.” Only the former requires strict tracing. The Sereboffs had argued that an equitable lien could not be imposed by agreement in a case such as theirs, because when the beneficiary agrees to such a provision “‘no third-party recovery’ exists which the beneficiary ‘can place … beyond his control and grant [the fiduciary] a complete and present right therein.’”
Justice Roberts concluded that, under long-standing Supreme Court precedent, the fund over which the lien is asserted need not be in existence when the contract containing the lien provision is executed. Thus, for a plan fiduciary to obtain recovery, as a threshold matter the plan document (as well as, presumably, the summary plan description) must clearly obligate the participant to reimburse the plan from specifically identifiable funds. Notably, Justice Roberts began his opinion by quoting the plan provision in question.
Sereboff argued before the Court that, if the participant receives less than a full recovery, the relief cannot be characterized as “truly equitable.” These objections were brushed aside in this case on another basis. The Court, however, declined to consider the question of whether the equitable relief the fiduciary sought was “appropriate,” as the statute requires, on the basis that it had not been timely raised.
It is not clear whether the existence of the agreement (the plan provision governing the “Acts of Third Parties”) is sufficient in and of itself to create an equitable lien established by agreement, or whether the equitable lien was permitted by the fact that the District Court approved a stipulation by the parties agreeing to preserve a specified amount in an investment account until the District Court ruled on the merits and all appeals were exhausted. The key aspect of the Court’s reasoning in the case was based on the fact that the plan fiduciary sought:
“[S]pecifically identifiable” funds that were “within the possession and control of the Sereboffs”—that portion of the tort settlement due Mid Atlantic under the terms of the ERISA plan, set aside and “preserved [in the Sereboffs’] investment accounts.”
The potential arguments and factual distinctions are readily apparent in situations where a segregated investment account does not exist or where the participant does not continue to hold the money."
Counsel for Sereboff argued that Knudson imposed a strict “tracing requirement” on all recoveries – i.e., that the funds the plan sought to recover must be directly traceable to those the plan had advanced.
Justice Roberts, however, distinguished between an “equitable lien sought as a matter of restitution” and an “equitable lien imposed by agreement.” Only the former requires strict tracing. The Sereboffs had argued that an equitable lien could not be imposed by agreement in a case such as theirs, because when the beneficiary agrees to such a provision “‘no third-party recovery’ exists which the beneficiary ‘can place … beyond his control and grant [the fiduciary] a complete and present right therein.’”
Justice Roberts concluded that, under long-standing Supreme Court precedent, the fund over which the lien is asserted need not be in existence when the contract containing the lien provision is executed. Thus, for a plan fiduciary to obtain recovery, as a threshold matter the plan document (as well as, presumably, the summary plan description) must clearly obligate the participant to reimburse the plan from specifically identifiable funds. Notably, Justice Roberts began his opinion by quoting the plan provision in question.
Sereboff argued before the Court that, if the participant receives less than a full recovery, the relief cannot be characterized as “truly equitable.” These objections were brushed aside in this case on another basis. The Court, however, declined to consider the question of whether the equitable relief the fiduciary sought was “appropriate,” as the statute requires, on the basis that it had not been timely raised.
It is not clear whether the existence of the agreement (the plan provision governing the “Acts of Third Parties”) is sufficient in and of itself to create an equitable lien established by agreement, or whether the equitable lien was permitted by the fact that the District Court approved a stipulation by the parties agreeing to preserve a specified amount in an investment account until the District Court ruled on the merits and all appeals were exhausted. The key aspect of the Court’s reasoning in the case was based on the fact that the plan fiduciary sought:
“[S]pecifically identifiable” funds that were “within the possession and control of the Sereboffs”—that portion of the tort settlement due Mid Atlantic under the terms of the ERISA plan, set aside and “preserved [in the Sereboffs’] investment accounts.”
The potential arguments and factual distinctions are readily apparent in situations where a segregated investment account does not exist or where the participant does not continue to hold the money."
Ketek (Antibiotic): Link to Liver failure?
The FDA reports that the antibiotic Ketek may be linked to twelve cases of liver failure (including four deaths). The FDA recommends that Sanofi-Aventis adds a warning label to the drug's packaging.
Ketek was approved by the FDA in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
The FDA conclusion relates to a May 16, 2006 memorandum the FDA's Division of Drug Risk Evaluation. There had been information posted by the FDA in January of 2006 which you can read here.
To the shock of no one, the company has stated in a release that it continues to believe that Ketek is safe and effective when used as directed.
Sources include the WSJ print edition, AP, and Yahoo.
Ketek was approved by the FDA in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
The FDA conclusion relates to a May 16, 2006 memorandum the FDA's Division of Drug Risk Evaluation. There had been information posted by the FDA in January of 2006 which you can read here.
To the shock of no one, the company has stated in a release that it continues to believe that Ketek is safe and effective when used as directed.
Sources include the WSJ print edition, AP, and Yahoo.
Wednesday, May 17, 2006
Merck's Nifty Site Re: Vioxx Litigation
Thanks to Evan Schaeffer and Legal Underground for alerting me and others to this site from Merck: LearnaboutVioxx.com
Evan surmises that the site was possibly designed by defense attorneys for Merck. What do you think?
Evan surmises that the site was possibly designed by defense attorneys for Merck. What do you think?
Tuesday, May 16, 2006
ERISA, The Sereboff Decision, and a Work Around?
The decision by SCOTUS yesterday in Sereboff in my view makes the job even more difficult for lawyers who work with injured consumers.
A few comments:
Prior to settlement, my office always tries to negotiate with the health insurer or its agent. Most insurers now use recovery services such as Rawlings, and I do find it is easier to settle with them.
The Sereboff decision refers to "identifiable funds" in the possession of the beneficiary. Should any settlement check be made payable to the attorney and client, and thus not be considered solely identifiable to the plan beneficiary?
In the opinion Roberts declined to consider that the injured claimants could raise equitable defenses to the claim of lien, such as the made whole doctrine because “this distinct assertion” wasn’t raised in the lower court. I face this issue on catastrophic injuries with limited insurance.
It may that ATLA’s amicus brief may give you guidance in the event that suit is filed against your client. ATLA encouraged the Court to consider a theory of “Equitable Reimbursement” which would also include provision for payment of attorneys fees and costs.
If you have thoughts about how you may handle ERISA claims in the post Sereboff world, drop me a note.
A few comments:
Prior to settlement, my office always tries to negotiate with the health insurer or its agent. Most insurers now use recovery services such as Rawlings, and I do find it is easier to settle with them.
The Sereboff decision refers to "identifiable funds" in the possession of the beneficiary. Should any settlement check be made payable to the attorney and client, and thus not be considered solely identifiable to the plan beneficiary?
In the opinion Roberts declined to consider that the injured claimants could raise equitable defenses to the claim of lien, such as the made whole doctrine because “this distinct assertion” wasn’t raised in the lower court. I face this issue on catastrophic injuries with limited insurance.
It may that ATLA’s amicus brief may give you guidance in the event that suit is filed against your client. ATLA encouraged the Court to consider a theory of “Equitable Reimbursement” which would also include provision for payment of attorneys fees and costs.
If you have thoughts about how you may handle ERISA claims in the post Sereboff world, drop me a note.
Monday, May 15, 2006
ERISA Decision by SCOTUS 5/12/06
In Sereboff v. MidAtlantic Medical Services the Court has held that plan fiduciaries under the Employment Retirement Income Security Act can bring a civil action under Section 502(a)(3) of the act to obtain "appropriate equitable relief" to recover money that plan participants received from another source.
You can find the decision here.
You can find the decision here.
Vioxx in the Wall Street Journal Again, Page 1
How the New England Journal Missed Warning Signs on Vioxx is the title of the article. The article refers to a radio show whose guest was Jeffrey Drazen at that time the top editor of the New England Journal of Medicine. The WSJ article refers to an audio exchange, and you can find it by going here.
It's in Real Audio format. A pharmacist calls in to the show and asks why NEJM had not commented on Vioxx in 2001.
It's in Real Audio format. A pharmacist calls in to the show and asks why NEJM had not commented on Vioxx in 2001.
Vioxx: Is Risk Reduced After Use Ends?
My Friday May 12, 2006 post referred to data released May 11, 2006 by Merck. The same day and the next, headlines touted different conclusions.
The battle that now lays ahead is from the APPROVe study. The study found that patients taking Vioxx during the first three years of the study had a 92% higher risk of stroke and heart attack than those taking an inactive placebo pill.
The "preliminary" data released indicates that in the year after stopping Vioxx, 1,721 patients had a 74% higher stroke/heart attack risk. During that year, 28 patients who had taken Vioxx -- and 16 patients who had taken placebo pills -- had a stroke or heart attack. Most of these events were strokes.
According to various Merck employees' statement, the difference is not statistically significant, meaning it could be a chance finding. Merck says this means there isn't any risk to people who stop taking Vioxx -- at least, no scientifically proven risk.
According to a report on Webmc.com however:This is not so. Steve Nissen, MD, interim chairman of the department of cardiovascular medicine at The Cleveland Clinic has said: "What this means is the relative risk of an event with Vioxx, even after the drug was stopped, was very similar to the risk while taking the drug."
"It has profound implications for patients. It means that patients who previously took Vioxx must be followed closely and must be made aware of their increased risk."
Another doctor said, "I would say the numbers are small, but they suggest an ongoing risk from Vioxx in those who stopped taking it. There appears to be this same increase in risk as seen while taking the drug. While the difference is not statistically significant, it is concerning." (Per Michael Farkouh, MD).
"This suggests Vioxx has more than a [blood-clot-promoting] effect," he says. "It suggests more is going on with this drug than we thought. I would say it is possible it causes persistent damage to the arteries."
You can read more from this well done report by going here.
The battle that now lays ahead is from the APPROVe study. The study found that patients taking Vioxx during the first three years of the study had a 92% higher risk of stroke and heart attack than those taking an inactive placebo pill.
The "preliminary" data released indicates that in the year after stopping Vioxx, 1,721 patients had a 74% higher stroke/heart attack risk. During that year, 28 patients who had taken Vioxx -- and 16 patients who had taken placebo pills -- had a stroke or heart attack. Most of these events were strokes.
According to various Merck employees' statement, the difference is not statistically significant, meaning it could be a chance finding. Merck says this means there isn't any risk to people who stop taking Vioxx -- at least, no scientifically proven risk.
According to a report on Webmc.com however:This is not so. Steve Nissen, MD, interim chairman of the department of cardiovascular medicine at The Cleveland Clinic has said: "What this means is the relative risk of an event with Vioxx, even after the drug was stopped, was very similar to the risk while taking the drug."
"It has profound implications for patients. It means that patients who previously took Vioxx must be followed closely and must be made aware of their increased risk."
Another doctor said, "I would say the numbers are small, but they suggest an ongoing risk from Vioxx in those who stopped taking it. There appears to be this same increase in risk as seen while taking the drug. While the difference is not statistically significant, it is concerning." (Per Michael Farkouh, MD).
"This suggests Vioxx has more than a [blood-clot-promoting] effect," he says. "It suggests more is going on with this drug than we thought. I would say it is possible it causes persistent damage to the arteries."
You can read more from this well done report by going here.
Friday, May 12, 2006
Vioxx: Heart Attack After Discontinuing Use Does AND Does Not Have An Effect
Clear as mud, right? In the WSJ today, the headline reads: Merck Study Finds A Vioxx Risk After Use Ended. If you went online, however, to read more about this development, you will find this article online:
"Study Finds Vioxx Users Not at Higher Risk of Heart Attack, Stroke in Year After Stopping Drug," which you can find here.
So which is it? Is the AP correct? WSJ? In a Reuters article, there was this comment:
The company followed patients for another year as part of the original APPROVe study design to assess possible health consequences for those no longer taking the drug.
Merck said 28 Vioxx patients had adverse heart events compared with 16 in the placebo group. That study is the one known as: Adenomatous Polyp Prevention with VIOXX.
Looking at the data and information released yesterday right now. Once digested, I should be able to post it here in PDF format.
"Study Finds Vioxx Users Not at Higher Risk of Heart Attack, Stroke in Year After Stopping Drug," which you can find here.
So which is it? Is the AP correct? WSJ? In a Reuters article, there was this comment:
The company followed patients for another year as part of the original APPROVe study design to assess possible health consequences for those no longer taking the drug.
Merck said 28 Vioxx patients had adverse heart events compared with 16 in the placebo group. That study is the one known as: Adenomatous Polyp Prevention with VIOXX.
Looking at the data and information released yesterday right now. Once digested, I should be able to post it here in PDF format.
Meridia Appellate Decision: Daubert Excludes Expert Testimony
Th never ending litigation involving Meridia had an issue rendered by the Sixth Circuit Appeals Court on May 11, 2006. Meridia is a drug that is prescribed to treat obesity.
The appellate decision affirmed a lower court decision to exclude a pharmacologist's opinion that the elevation in blood pressure caused by Meridia outweighed any health benefits.
Go here to read the PDF opinion.
More later after I have had a chance to digest it.
The appellate decision affirmed a lower court decision to exclude a pharmacologist's opinion that the elevation in blood pressure caused by Meridia outweighed any health benefits.
Go here to read the PDF opinion.
More later after I have had a chance to digest it.
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