There have been several reports suggesting that the cardiovascular risks of the two drugs are allegedly about the same.
Both drugs are members of the family known as thizolidinediones, which decrease the insulin resistance of body tissues and modify the production of cholesterol. They are considered among the most powerful drugs for treating Type 2 diabetes but have been plagued by reports of side effects. A 2007 study of more than 200,000 Medicare patients suggested that Avandia, known generically as rosiglitazone, increased the risk of heart attack, cardiovascular disease, stroke and death by 30% to 40% compared with metformin and other, older diabetes drugs. That study also suggested that the increased risk was not observed with Actos, known generically as pioglitazone.
Source.
I am Hispanic, so I'm going to also start writing periodically in Spanish as well. Here's my first attempt:
Ha habido varios reportes que sugieren que los riesgos cardiovasculares de las dos drogas son supuestamente acerca de lo mismo.
Ambas drogas son miembros de la familia conocida como thizolidinediones, que disminuye la resistencia de insulina de tejidos de cuerpo y modifica la producción de colesterol. Son considerados entre las drogas más poderosas para de tipo tratar 2 diabetes pero han sido plagados por reportes de efectos secundario. Un 2007 estudio de más de 200.000 pacientes de Medicare sugirió que Avandia, conocido genéricamente como rosiglitazone, aumentó el riesgo de infarto, la enfermedad cardiovascular, el golpe y la muerte por 30% a 40% comparado con metformin y con otro, las drogas más viejas de la diabetes. Ese estudio también sugirió que el riesgo aumentado no fue observado con Actos, conocido genéricamente como pioglitazone.
Thursday, August 26, 2010
Tuesday, August 24, 2010
LNG Tankers on Savannah Roadways: A Dangerous and Lethal Mix
Recently a Liquid Natural Gas producer suggested it should be allowed to deliver LNG from Savannah, GA throughout the south, to include Atlanta.
From Savannahnow.com:
A new proposal from the operator of Elba Island, one of the largest importers of liquefied natural gas or LNG in the country, would have some of that natural gas stay in its liquid state and make the journey out of Elba by tanker truck. The proposed route takes 13,000- gallon double-walled tanker trucks south on the Truman Parkway and then across DeRenne Avenue to I-516. Southeast LNG wants to start its trucking operation in late 2012 with 8-10 trucks a day and ramp up to 58 trucks a day over the ensuing decade.
Both the idea of additional traffic and the transport of hazardous material on DeRenne worry some who live along the already beleaguered corridor.
The Danger?
What is the danger? Outside of normal wrecks, tankers are prone to rollovers.
LNG tankers make perfect terrorist bombs. In Savannah these trucks will pass right by Hunter Army Airfield. It is a military airfield and subordinate installation to Fort Stewart.
Hunter features a runway that is 11,375 feet (3,468 m) long and an aircraft parking area that is more than 350 acres (1.4 km²). The runway and apron, combined with the 72,000 sq ft (6,689 m²) Arrival/Departure Airfield Control Group (A/DACG) Facility and nearby railhead, allow the 3rd Infantry Division from nearby Fort Stewart to efficiently deploy soldiers and cargo worldwide. NASA identified Hunter as an alternate landing site for the Space Shuttle orbiters.
In 1944 a LNG explosion leveled one square mile of Cleveland, known as the Cleveland Disaster. The very first commercial LNG facility built in the United States in 1941, caused a major industrial accident known as the "The Cleveland Disaster." According to the U.S. Bureau of Mines report, LNG holding tanks failed and released their contents into the streets and sewers and their vaporous cloud ignited and fire engulfed the nearby residents and commercial establishments.
The Fiery Inferno Devastated One Square Mile Of Cleveland, Ohio. Liquefied Natural Gas Destroyed 79 Homes, 2 Factories, 217 Cars,7 Trailers, Left 680 Homeless,Injured 225 and Killed 131.
In 2004, a blast at Algerian liquefied natural gas plant killed 27 people.
In Savannah, they propose 58 trucks a day passing local retail stores, businesses with thousands of jobs and homes and families.
Each truck tanker will have 13,000 gallons of Liquid Natural Gas which in a wreck, if released, may convert from liquid to vapor and expand to 600 times to about 8 million gallons of gas....
This would will produce about a 5,000 degree fire.
Simply stated, this is a bad idea. Time to kill the proposal now.
From Savannahnow.com:
A new proposal from the operator of Elba Island, one of the largest importers of liquefied natural gas or LNG in the country, would have some of that natural gas stay in its liquid state and make the journey out of Elba by tanker truck. The proposed route takes 13,000- gallon double-walled tanker trucks south on the Truman Parkway and then across DeRenne Avenue to I-516. Southeast LNG wants to start its trucking operation in late 2012 with 8-10 trucks a day and ramp up to 58 trucks a day over the ensuing decade.
Both the idea of additional traffic and the transport of hazardous material on DeRenne worry some who live along the already beleaguered corridor.
The Danger?
What is the danger? Outside of normal wrecks, tankers are prone to rollovers.
LNG tankers make perfect terrorist bombs. In Savannah these trucks will pass right by Hunter Army Airfield. It is a military airfield and subordinate installation to Fort Stewart.
Hunter features a runway that is 11,375 feet (3,468 m) long and an aircraft parking area that is more than 350 acres (1.4 km²). The runway and apron, combined with the 72,000 sq ft (6,689 m²) Arrival/Departure Airfield Control Group (A/DACG) Facility and nearby railhead, allow the 3rd Infantry Division from nearby Fort Stewart to efficiently deploy soldiers and cargo worldwide. NASA identified Hunter as an alternate landing site for the Space Shuttle orbiters.
In 1944 a LNG explosion leveled one square mile of Cleveland, known as the Cleveland Disaster. The very first commercial LNG facility built in the United States in 1941, caused a major industrial accident known as the "The Cleveland Disaster." According to the U.S. Bureau of Mines report, LNG holding tanks failed and released their contents into the streets and sewers and their vaporous cloud ignited and fire engulfed the nearby residents and commercial establishments.
The Fiery Inferno Devastated One Square Mile Of Cleveland, Ohio. Liquefied Natural Gas Destroyed 79 Homes, 2 Factories, 217 Cars,7 Trailers, Left 680 Homeless,Injured 225 and Killed 131.
In 2004, a blast at Algerian liquefied natural gas plant killed 27 people.
In Savannah, they propose 58 trucks a day passing local retail stores, businesses with thousands of jobs and homes and families.
Each truck tanker will have 13,000 gallons of Liquid Natural Gas which in a wreck, if released, may convert from liquid to vapor and expand to 600 times to about 8 million gallons of gas....
This would will produce about a 5,000 degree fire.
Simply stated, this is a bad idea. Time to kill the proposal now.
Guest Post from Trucking Attorney Joe Fried
Image by ER24 EMS (Pty) Ltd. via Flickr - Joe Fried and his firm are to me the consummate trucking lawyers. He's accomplished and to be blunt, knows his stuff. Here's a guest post from Joe:
I recently was asked to do a presentation to a bunch of lawyers and police officers on the current state of technology with tractor trailer black boxes. So, I had to brush up to make sure my information was current. I thought this may be useful to some of you who handle tractor trailer cases.
Most large truck engines have an engine control module (ECM), sometimes called a black box or an Electronic Data Recorder (EDR), that is responsible for monitoring and controlling important engine and vehicle parameters, such as speed, throttle, and braking. You can download this information from the truck engine, but what exactly you should expect to get depends very much on the manufacture of the engine and the date of manufacture.
In this post, I present you with what you can expect from a Caterpillar engine. If you would like to know what to expect from other manufacturers (Detroit Diesel, Mack, Cummins, International), shoot me an e-mail at joe@thetruckingattorneys.com (Put “ECM paper” in the subject box) and I will get you a copy of the entire paper. The powerpoint slides I used in my presentation is available at Slideshare.com.
Here is the skinny on the Caterpillar black box ECM:
Used in many Peterbilt, Kenworth and International tractors.
Caterpillar engine ECMs have been able to record sudden decelerations (“quick stops”) since 1995, but the factory default was set to not record any such data. Some customers change this threshold but not many. For these engines, there is no way to determine with the data will be recorded without downloading the box.
Starting in 2007 the engines started being shipped with “quick stop” function set to “on.” This was the result of new environmental standards. The quick stop record contains 45 seconds of data before the threshold is met and 15 seconds of data after the threshold is reached.
The Quick Stop Record contains:
· Wheel speed (mph)
· Engine load (percent)
· Service brake status (on/off)
· Clutch status (on/off)
· Cruise control status (on/off)
· Other parameters defined by end-user
Caterpillar engine ECMs will also record a report called a “snap shot” if the engine senses a critical fault in the engine such as dangerously low oil pressure. When triggered the ECM will capture about 9 seconds leading up to the fault and 3 seconds after the fault is triggered. This can be useful in timing a collision, but it is not nearly as helpful as a DDEC.
Avandia Georgia/Florida: TIDE Letter
Excerpt from the Tide Trial letter:
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee
Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.
As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.
As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.
This is the letter that went with the Glaxo letter to others.
http://www.markzamora.com/AvandiaFLA/index.html
Last week we infonned you of the United States Food and Drug Administration's (FDA)
decision to place a partial clinical hold on the TIDE trial (i.e. to continue following randomized
participants but to not randomize new participants). In the letter we also infonned you that you
would receive a summary of the infonnation that was presented at the FDA Advisory Committee
Meeting on July 13 and 14,2010. As requested by the FDA, this summary document was written
by the Sponsor, GlaxoSmithKline. It has now been completed and includes the questions that
the panel voted on and the tally of the votes. It is attached to this email.
As mentioned in last week's note and as requested by the FDA, please send this document to
your local ethics committees as soon as possible for their infonnation, together with the short
cover note that you may want to modify to accompany the document. As you will recall, last
week we provided participant infonnation letters that describe the FDA meeting. However, if
you or your ethics committee feel that the current consent fonn should be modified for the
current participants, please do so. Finally, if applicable for your site, your local sponsor team will
submit this letter to the central ethics committee on your behalf. It will also provide a copy of
the document to the regulatory agency in your country according to local requirements.
As noted last week, the TIDE leadership remain committed to the relevance and appropriateness
of this trial regardless of the current controversy. We will certainly continue to keep you
infonned of any new developments. In the meantime, it remains important that the interests and
the autonomy of the study participants be paramount and that any questions that they may have
should be openly addressed.
This is the letter that went with the Glaxo letter to others.
http://www.markzamora.com/AvandiaFLA/index.html
Florida Bar: Proposed Rule on Lien Outsourcing
There has been some concern and questions regarding the outsourcing of lien resolution and the ability to pass along those costs to the client. There were also questions regarding cases where another lawyer handles a lien resolution issue on a reverse contingency and how fees could be charged. The bar formed a committee to look at these issues after an ethics opinion request. The committee has issued a new proposed rule (please see below) that would allow for a lawyer to outsource if it is disclosed in the initial fee contract. The costs come out of the client's recovery, not the lawyer's contingent fee. The new rule is not final until approved by the Florida Supreme Court and may be tweaked by the bar through its internal review process in between now and when the Supreme Court reviews it.
Proposed New Rule language:
(E) The lawyer shall include in the contract an explanation of the scope of any subrogation or lien resolution services the lawyer will undertake at the conclusion of the primary matter. The lawyer may not charge additional fees for handling lien resolution services if those additional fees, when combined with the lawyer's fees for handling the primary claim would exceed the contingent fee schedule set forth in this subdivision. If extraordinary subrogation or lien resolution services are handled by others outside the primary lawyer's firm who will charge additional attorney's fees or costs to the client, these services shall only be provided after obtaining the client's informed written consent to the additional fees or costs. Any additional fees or costs charged by the other lawyer involved in the subrogation or lien resolution services must separately comply with the provisions of Rules 4-1.5(a) through 4-1.5(e), and if the fees are contingent on the outcome of the lien resolution, the lien or subrogation resolution fees on their own must also comply with Rule 4-1.5(f).
New Comment language:
Rule 4-1.5(f)(4)(E) addresses the resolution of medical liens and subrogation claims that are directly related to the underlying personal injury or wrongful death case in which the lawyer represents a client. This subdivision requires that the lawyer undertaking the personal injury or wrongful death case set forth in the lawyer's fee contract with the client whether the lawyer will undertake the resolution of any medical liens or subrogation claims related to the personal injury or wrongful death case as part of the lawyer's services in that case. Extraordinary subrogation or lien resolution services are those that are beyond simple negotiation by the original lawyer. As part of every personal injury and wrongful death case, the lawyer handling the matter has an obligation under his contingent fee contract to ascertain the existence of any medical liens and subrogation claims, advise the client of their existence, make reasonable efforts to negotiate liens that are negotiable, and disburse the amounts to lien holders and subrogation claimants as agreed by both the client and the third party and under the trust accounting rules set forth in chapter 5 of these rules.
A lawyer is not obligated to file or defend a separate lawsuit to resolve medical liens or subrogation claims as part of the lawyer's original agreement to represent the client in the personal injury or wrongful death matter, unless the lawyer makes a specific agreement to do so. Additionally, some liens or claims are so complex that they cannot be resolved through standard negotiation that is normally undertaken by the lawyer handling the personal injury or wrongful death case. In such cases, the client's best interests may best be served by having the lien and/or subrogation matters resolved by another with significant experience in this field. Therefore, a lawyer may indicate in the lawyer's initial fee contract that the lawyer will not undertake any resolution of medical liens or subrogation claims beyond the identification, negotiation, and disbursement described above. In such circumstances, or when reasonable efforts to negotiate such liens or claims fail, the lawyer may, with the client's informed consent, either refer the client to a third party or hire a third party on behalf of the client to handle the medical lien and/or subrogation claim resolution who may charge an additional fee or cost to the client. If a lawyer provides the additional services, that lawyer's contract with the client must separate comply with all provisions of rule 4-1.5.
The original lawyer handling the personal injury matter should not make an agreement to divide fees with the third party to whom the lawyer refers the additional lien and/or subrogation resolution services, as the division of fees would result in an excessive fee to the original lawyer and would likely exceed the contingent fee schedule. If the additional services are to be provided by another, the lawyer should first determine whether the services constitute the practice of law and, if so, should not refer those services to a nonlawyer or someone not authorized to provide the services. A lawyer's duties when a third party claims an interest in funds held by the lawyer are addressed in rule 5-1.1(f) and comment.
Rule 4-1.5(f)(4)(F) discusses a lawyer's obligations in a personal injury or wrongful death case in which an estate must be opened or a guardianship must be established. In a wrongful death case, often an estate must be opened to appoint a personal representative who will act on behalf of the estate of the decedent. In personal injury cases in which minors are involved, or in which a person is under a disability and cannot adequately act on his or her own behalf, often a guardianship must be established. The probate and guardianship matters are separate legal matters in which a separate reasonable fee may be charged. The probate and guardianship matters are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule. Likewise, ancillary services such as estate planning, bankruptcy, financial planning, public benefit planning, tax planning, real estate transactions, and Medicare set-asides are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule.
Proposed New Rule language:
(E) The lawyer shall include in the contract an explanation of the scope of any subrogation or lien resolution services the lawyer will undertake at the conclusion of the primary matter. The lawyer may not charge additional fees for handling lien resolution services if those additional fees, when combined with the lawyer's fees for handling the primary claim would exceed the contingent fee schedule set forth in this subdivision. If extraordinary subrogation or lien resolution services are handled by others outside the primary lawyer's firm who will charge additional attorney's fees or costs to the client, these services shall only be provided after obtaining the client's informed written consent to the additional fees or costs. Any additional fees or costs charged by the other lawyer involved in the subrogation or lien resolution services must separately comply with the provisions of Rules 4-1.5(a) through 4-1.5(e), and if the fees are contingent on the outcome of the lien resolution, the lien or subrogation resolution fees on their own must also comply with Rule 4-1.5(f).
New Comment language:
Rule 4-1.5(f)(4)(E) addresses the resolution of medical liens and subrogation claims that are directly related to the underlying personal injury or wrongful death case in which the lawyer represents a client. This subdivision requires that the lawyer undertaking the personal injury or wrongful death case set forth in the lawyer's fee contract with the client whether the lawyer will undertake the resolution of any medical liens or subrogation claims related to the personal injury or wrongful death case as part of the lawyer's services in that case. Extraordinary subrogation or lien resolution services are those that are beyond simple negotiation by the original lawyer. As part of every personal injury and wrongful death case, the lawyer handling the matter has an obligation under his contingent fee contract to ascertain the existence of any medical liens and subrogation claims, advise the client of their existence, make reasonable efforts to negotiate liens that are negotiable, and disburse the amounts to lien holders and subrogation claimants as agreed by both the client and the third party and under the trust accounting rules set forth in chapter 5 of these rules.
A lawyer is not obligated to file or defend a separate lawsuit to resolve medical liens or subrogation claims as part of the lawyer's original agreement to represent the client in the personal injury or wrongful death matter, unless the lawyer makes a specific agreement to do so. Additionally, some liens or claims are so complex that they cannot be resolved through standard negotiation that is normally undertaken by the lawyer handling the personal injury or wrongful death case. In such cases, the client's best interests may best be served by having the lien and/or subrogation matters resolved by another with significant experience in this field. Therefore, a lawyer may indicate in the lawyer's initial fee contract that the lawyer will not undertake any resolution of medical liens or subrogation claims beyond the identification, negotiation, and disbursement described above. In such circumstances, or when reasonable efforts to negotiate such liens or claims fail, the lawyer may, with the client's informed consent, either refer the client to a third party or hire a third party on behalf of the client to handle the medical lien and/or subrogation claim resolution who may charge an additional fee or cost to the client. If a lawyer provides the additional services, that lawyer's contract with the client must separate comply with all provisions of rule 4-1.5.
The original lawyer handling the personal injury matter should not make an agreement to divide fees with the third party to whom the lawyer refers the additional lien and/or subrogation resolution services, as the division of fees would result in an excessive fee to the original lawyer and would likely exceed the contingent fee schedule. If the additional services are to be provided by another, the lawyer should first determine whether the services constitute the practice of law and, if so, should not refer those services to a nonlawyer or someone not authorized to provide the services. A lawyer's duties when a third party claims an interest in funds held by the lawyer are addressed in rule 5-1.1(f) and comment.
Rule 4-1.5(f)(4)(F) discusses a lawyer's obligations in a personal injury or wrongful death case in which an estate must be opened or a guardianship must be established. In a wrongful death case, often an estate must be opened to appoint a personal representative who will act on behalf of the estate of the decedent. In personal injury cases in which minors are involved, or in which a person is under a disability and cannot adequately act on his or her own behalf, often a guardianship must be established. The probate and guardianship matters are separate legal matters in which a separate reasonable fee may be charged. The probate and guardianship matters are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule. Likewise, ancillary services such as estate planning, bankruptcy, financial planning, public benefit planning, tax planning, real estate transactions, and Medicare set-asides are not considered part of the personal injury or wrongful death matter for which the lawyer is subject to the contingent fee schedule set forth in this rule.
Monday, August 23, 2010
Total Body Cleanse Lawsuits
Total Body Cleanse Lawsuit information:
In a filed lawsuit, the Plaintiff claims Jillian Michaels' "Triple Process Total Body Detox & Cleanse" diet supplement contains a "potentially lethal combination of toxic ingredients" ... and it "might kill you."
In the suit, R.D. lays out what she considers to be the risks associated with various ingredients in Jillian's product, including:
-- Irish Moss Powder ... "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
-- Bearberry ... "known to cause nausea and vomiting"
-- Yarrow ... "a toxic lawn weed that causes dermatitis"
-- Chinese Rhubarb ... "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
-- Fenugreek Seed ... "interferes with digestion and causes both diarrhea and gas"
In a filed lawsuit, the Plaintiff claims Jillian Michaels' "Triple Process Total Body Detox & Cleanse" diet supplement contains a "potentially lethal combination of toxic ingredients" ... and it "might kill you."
In the suit, R.D. lays out what she considers to be the risks associated with various ingredients in Jillian's product, including:
-- Irish Moss Powder ... "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
-- Bearberry ... "known to cause nausea and vomiting"
-- Yarrow ... "a toxic lawn weed that causes dermatitis"
-- Chinese Rhubarb ... "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
-- Fenugreek Seed ... "interferes with digestion and causes both diarrhea and gas"
FDA: Rodents at GA warehouse that held jail food
Image via WikipediaAuthorities seized nearly $1 million worth of cookies, crackers and other packaged food that was bound for jails and prisons throughout the Southeast after rodents were found at an unlicensed Georgia warehouse.The Mid-States Services Inc. warehouse shipped to six Georgia facilities, though their names were not immediately released. FDA spokesman Ira Allen would not say which out-of-state facilities received products, citing proprietary protections.
Oscar Garrison, assistant commissioner for consumer protection with the Georgia Department of Agriculture, said the FDA received a complaint about the facility, and officials discovered it didn't have a license.
Georgia law requires a license for facilities that store, sell or manufacturer food.
Source
Painkiller: Stroke Risk?
Image via WikipediaResearchers found that among nearly 38,000 Taiwanese adults who suffered a stroke over one year, the use of a non-steroidal anti-inflammatory drug (NSAID) in the prior month may have elevated their stroke risk.The increases linked to individual NSAIDs were generally modest, the investigators report in the medical journal Stroke. And the findings do not prove that the medications themselves led to some people's strokes.
NSAIDs are a group of painkillers that include over-the-counter medications like aspirin, ibuprofen (Advil, Motrin and other brands) and naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors.
The COX-2 inhibitors were first linked to an increased risk of heart attack and other cardiovascular problems, and two of the drugs -- rofecoxib (Vioxx) and valdecoxib (Bextra) -- were pulled from the market in 2004 and 2005, respectively; a third COX-2 inhibitor, celecoxib (Celebrex) remains on the market.
But subsequent studies also raised concerns about the possible heart risks of some of the older, over-the-counter NSAIDs, including ibuprofen and diclofenac (Voltaren).
These latest findings suggest that the "concern may also extend to the risk of stroke,"
Source
Friday, August 20, 2010
Avandia Georgia News
From the NYT:
Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.
Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.
Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
http://www.nytimes.com/2010/08/20/health/policy/20fda.html
Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.
Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.
Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
http://www.nytimes.com/2010/08/20/health/policy/20fda.html
Georgia: Trasylol Cases Settles
Bayer has agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol, a drug used to control bleeding during heart surgeries.
The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.
Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.
“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.
Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.
1,600 Suits
Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.
Steven Derringer, one of Bayer’s lawyers, told U.S. District Judge Donald Middlebrooks at a hearing in Palm Beach, Florida, earlier this year the company had devised a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation,” according to a court-hearing transcript.
Derringer also told Middlebrooks at the April 12 hearing that the drugmaker had settled a total of 63 cases at that time. The company brought in a mediator to help resolve the cases, according to the transcript.
“We now have a track record, your honor, that shows these cases are being settled, parties can agree on values, and settlements do not depend on trial dates,” Derringer said.
The company had settled “with about 120 plaintiffs as of July 6, 2010,” without making any admission of liability, Funk said in the e-mailed statement.
The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.
Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.
“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.
Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.
1,600 Suits
Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.
Steven Derringer, one of Bayer’s lawyers, told U.S. District Judge Donald Middlebrooks at a hearing in Palm Beach, Florida, earlier this year the company had devised a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation,” according to a court-hearing transcript.
Derringer also told Middlebrooks at the April 12 hearing that the drugmaker had settled a total of 63 cases at that time. The company brought in a mediator to help resolve the cases, according to the transcript.
“We now have a track record, your honor, that shows these cases are being settled, parties can agree on values, and settlements do not depend on trial dates,” Derringer said.
The company had settled “with about 120 plaintiffs as of July 6, 2010,” without making any admission of liability, Funk said in the e-mailed statement.
Wednesday, August 11, 2010
FDA warns about IVC Filters
The FDA has warned that inferior vena cava (IVC) filters, devices inserted into a large vein to help prevent potentially deadly blood clots from reaching the lungs, might come apart, shift within the body or perforate the blood vessel.
IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC filters to be deployed in 2012 (Smouse and Johar, Endovascular Today, February 2010).
Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.
The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Diet Drugs to Get FDA Review
An FDA committee will review the safety risk of weight-loss drug Meridia the day before evaluating Arena Pharmaceuticals Inc.'s drug for treating obesity.
The agency had said it planned to review Abbott's Meridia, which has been pulled from the market in Europe on concerns about cardiovascular side effects; however, scheduling the session on Sept. 15, a day before Arena's meeting, sets up a situation similar to last month, when the same panel held a two-day safety review of Avandia before evaluating Qnexa.
The Avandia meeting's focus on safety concerns is thought to have contributed to the Endocrinologic and Metabolic Drugs Advisory Committee ultimately recommending that the FDA reject Vivus's Qnexa because of potential safety issues. The panel cited the lack of long-term safety data on a drug that could be used by millions of Americans for an indefinite period.
The agency had said it planned to review Abbott's Meridia, which has been pulled from the market in Europe on concerns about cardiovascular side effects; however, scheduling the session on Sept. 15, a day before Arena's meeting, sets up a situation similar to last month, when the same panel held a two-day safety review of Avandia before evaluating Qnexa.
The Avandia meeting's focus on safety concerns is thought to have contributed to the Endocrinologic and Metabolic Drugs Advisory Committee ultimately recommending that the FDA reject Vivus's Qnexa because of potential safety issues. The panel cited the lack of long-term safety data on a drug that could be used by millions of Americans for an indefinite period.
Seroquel cases settle
Image via Wikipedia The settlements resulted from a court-ordered mediation. AstraZeneca had previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said.
Monday, August 09, 2010
Total Body Cleanse Lawsuits
"Biggest Loser" trainer Jillian Michaels sells a diet supplement, the Triple Process Total Body Detox & Cleanse, that "just might kill you," according to a lawsuit. .
It has been claimed that the product Contains a potentially lethal combination of toxic ingredients that can cause ulcers, nausea, vomiting, dehydration, liver damage, and diarrhea the class claims which is not how consumers expect to be 'detoxed and cleansed.'
The claimed dangerous ingredients are:
It has been claimed that the product Contains a potentially lethal combination of toxic ingredients that can cause ulcers, nausea, vomiting, dehydration, liver damage, and diarrhea the class claims which is not how consumers expect to be 'detoxed and cleansed.'
The claimed dangerous ingredients are:
- Irish Moss Powder: "causes gastrointestinal ulcers" and is "so toxic that it is the gel commonly applied to aircraft wings to dissolve ice"
- Bearberry: "known to cause nausea and vomiting"
- Yarrow: "a toxic lawn weed that causes dermatitis"
- Chinese Rhubarb: "a harsh laxative and dangerous diuretic that can cause sever dehydration and may cause irreversible liver damage"
- Fenugreek Seed: "interferes with digestion and causes both diarrhea and gas."
Thursday, July 29, 2010
Burgeoning Scandal? Insurance for the Department of Veterans Affairs and Payments to Deceased Veterans
Get ready to get angry when you read this. How this happens to the family of those who made the ultimate sacrifice for our country. From the St. Pete Times:
Prudential handles life insurance for the Department of Veterans Affairs, sent a letter about a deceased's $400,000 policy. And something that looked like a checkbook. The letter told Lohman that the full amount of her payout would be placed in a convenient interest-bearing account, allowing her time to decide how to use the benefit. "You can hold the money in the account for safekeeping for as long as you like," the letter said.
In small print, in a disclaimer Lohman said she didn't notice, Prudential disclosed that what it called its Alliance Account was not guaranteed by the Federal Deposit Insurance Corp.
Lohman, 52, left the money untouched for six months after her son's August 2008 death. As time went on she tried to use one of the "checks" to buy a bed, and the salesman rejected it. That happened again this year when she went to a Target to purchase a camera.
Lohman says she believed her son's life insurance funds were in a bank insured by the FDIC. That money — like $28 billion in 1 million death-benefit accounts managed by insurers — wasn't sitting in a bank. It was being held in Prudential's general corporate account, earning investment income for the insurer.
More ...
'Millions of bereaved Americans have unwittingly been placed in the same position by their insurance companies. The practice of issuing what they call "checkbooks" to survivors, instead of paying them lump sums, extends well beyond the military. In the past decade, these so-called retained-asset accounts have become standard operating procedure in an industry that touches virtually every American: There are more than 300 million active life insurance policies in the United States, and the industry holds $4.6 trillion in assets, according to the American Council of Life Insurers. '
Insurance companies — in addition to holding onto the money of survivors, paying them uncompetitive interest rates and giving them misleading guarantees — may be violating a federal bank law.
http://www.tampabay.com/news/business/banking/insurers-profit-from-delayed-life-insurance-payouts-to-bereaved-families/1111839
Prudential handles life insurance for the Department of Veterans Affairs, sent a letter about a deceased's $400,000 policy. And something that looked like a checkbook. The letter told Lohman that the full amount of her payout would be placed in a convenient interest-bearing account, allowing her time to decide how to use the benefit. "You can hold the money in the account for safekeeping for as long as you like," the letter said.
In small print, in a disclaimer Lohman said she didn't notice, Prudential disclosed that what it called its Alliance Account was not guaranteed by the Federal Deposit Insurance Corp.
Lohman, 52, left the money untouched for six months after her son's August 2008 death. As time went on she tried to use one of the "checks" to buy a bed, and the salesman rejected it. That happened again this year when she went to a Target to purchase a camera.
Lohman says she believed her son's life insurance funds were in a bank insured by the FDIC. That money — like $28 billion in 1 million death-benefit accounts managed by insurers — wasn't sitting in a bank. It was being held in Prudential's general corporate account, earning investment income for the insurer.
More ...
'Millions of bereaved Americans have unwittingly been placed in the same position by their insurance companies. The practice of issuing what they call "checkbooks" to survivors, instead of paying them lump sums, extends well beyond the military. In the past decade, these so-called retained-asset accounts have become standard operating procedure in an industry that touches virtually every American: There are more than 300 million active life insurance policies in the United States, and the industry holds $4.6 trillion in assets, according to the American Council of Life Insurers. '
Insurance companies — in addition to holding onto the money of survivors, paying them uncompetitive interest rates and giving them misleading guarantees — may be violating a federal bank law.
http://www.tampabay.com/news/business/banking/insurers-profit-from-delayed-life-insurance-payouts-to-bereaved-families/1111839
Thursday, July 22, 2010
Georgia Lawyer and Oil Spill Claims:Deepwater Study
Image by SkyTruth via FlickrOne that should come as no surprise: “This disaster was preventable had existing progressive guidelines and practices been followed. This catastrophic failure appears to have resulted from multiple violations of the laws of public resource development, and its proper regulatory oversight.”
The first DHSG progress report identified seven elements responsible for this disaster:
• Improper cement design (segmented discontinuous cement sheath).
• Flawed Quality Assurance and Quality Control (QA / QC) – no cement bond logs in critical sections of the well, ineffective oversight of operations.
• Bad decision making – removing the pressure barrier – displacing the drilling mud with sea water 8,000 feet below the drill deck.
• Loss of situational awareness – early warning signs not properly detected, analyzed or corrected (repeated major gas kicks, lost drilling tools, including evidence of damaged parts of the Blowout Preventer) during drilling and/or cementing, lost circulation, changes in mud volume and drill string weight).
• Improper operating procedures – premature off-loading of the drilling mud (weight material not available at critical time).
• Flawed design and maintenance of the final lines of defense – including the Blowout Preventers (BOPs) blind shear rams, hydraulic lines, and triggering equipment – and the Emergency Shutdown and Disconnect (ESD) systems.
And more:
In the case of the Deepwater Horizon’s BOPs, the first few days following the incident are very revealing and symptomatic of BP’s failed Safety Management System (SMS). The initial response by engineers was focused on trying to fully engage the rig’s single functional blind shear ram using Remote Operated Vehicles (ROVs). However, it did not work and, in fact, the BP engineers reportedly did not even have accurate information about how the BOPs had been previously modified and wasted precious time trying to activate the BOPs.
http://ccrm.berkeley.edu/deepwaterstudygroup.html
Georgia Avandia Lawyer and Avandia Clinical Trial News for July 22, 2010
Image via CrunchBaseThe clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.
The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug.
We are investigating claims regarding Avandia.
Tuesday, July 20, 2010
Restore the Gulf - Watch the Video, sign the Petition
I did. It's ours, mine, yours. My kids. My as yet unborn grandkids:
Arava Gets a Blackbox Warning
The FDA has added a blackbox warning about severe liver injury to the package label for Arava-- a disease-modifying anti-rheumatic drug used to treat RA The decision to add to the warning was based on the FDA's review of adverse event reports. The reports identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, that occurred between August 2002 and May 2009.
Patients at greatest risk for liver injury were identified as those taking other drugs known to cause liver injury and patients with pre-existing liver disease. The additional information being added to the Boxed Warning for Arava recommends that:
- Patients with pre-existing liver disease should not receive Arava.
- Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive Arava.
- Caution should be used in patients who take other drugs that can cause liver injury.
- Liver enzymes should be monitored at least monthly for 3 months after starting Arava and after that, at least quarterly.
- If ALT level rises to greater than two times the upper limit of normal while a patient is on Arava, the drug should be stopped, cholestyramine washout begun to speed removal of Arava from the body, and follow-up liver function tests conducted weekly until ALT returns to normal.
- Be aware that cases of severe liver injury have been reported in people taking leflunomide.
- Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
- Talk to your healthcare professional about any concerns you have with this medication.
- Report any side effects with leflunomide to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.
Source.
Study: Zinc-based Nose Spray/Loss of Smell Linked
Image by Getty Images via @daylifeA researcher who has taken the position that the sprays were harmful says he has scientific evidence to back up the claim. Courts, however, have yet to be convinced.
The analysis included 25 patients treated at the University of California, San Diego Nasal Dysfunction Clinic, which Terrence Davidson directs, who experienced loss of smell after using zinc nasal sprays or swabs to prevent or treat colds. Along with colleague Wendy M. Smith, MD, Davidson applied the nine-point Bradford Hill causation environmental exposure statistical measure to assess the probability that the cold-remedy use caused the loss of sense of smell.
Upper respiratory infections and nasal and sinus disease are major causes of both temporary and permanent loss of smell and diminished sense of smell.
In nearly a dozen cases, however, Courts have found little scientific evidence to support the claim that zinc-containing Zicam nasal products caused loss of smell. Daubert based decisions have resulted in claims not making it to a jury. Davidson himself was rejected as an expert witness when the judge ruled his opinions on specific causation to be “seriously flawed.”
Here's an excerpt from the opinion:
Rose v. Matrixx Initiatives, Inc., No. 07-2404-JPM/tmp, 2009 WL 902311 (W.D. Tenn. Mar. 31, 2009)
Dr. Davidson's opinions on specific causation are seriously flawed as the uncontradicted evidence demonstrates that Rose did not spray the Zicam into her right nostril and thus the Zicam could not have been the cause of her bilateral smell loss. . . .
Dr. Davidson's belief that Rose must have sprayed the Zicam into both nostrils and must have simply forgotten what had happened is not supported by any evidence in the record.
Id. at *16.
Source.
Monday, July 19, 2010
Georgia law: Apportionment Statute Ruling from Ct of Appeals
A recent ruling has far reaching effects in Georgia litigation. The case is CAVALIER CONVENIENCE, INC.,
v. SARVIS,A10A0538, A10A0539.
The issue presented in these appeals is whether, under recently amended OCGA § 51-12-33, a trier of fact is required to apportion its award of damages among multiple liable defendants when the plaintiff bears no fault.
The Court held: "It is clear from that subsection's plain language that the legislature did not intend for apportionment to be limited to those cases wherein the plaintiff was to some degree at fault."
The Court went on to hold that:
In accordance with the legislature's unambiguous language in OCGA § 51-12-33 (b), we hold that where damages are to be awarded in an action brought against more than one person for injury to person or property — whether or not such damages must be reduced pursuant to OCGA § 51-12-33 (a) — the trier of fact "shall . . . apportion its award of damages among the persons who are liable according to the percentage of fault of each person."[ 15 ] Had the legislature intended for subsection (b) of OCGA § 51-12-33 to be triggered only upon a reduction of damages pursuant to subsection (a) of that Code section, it could have so stated; but it did not impose any such prerequisite.
Find it here.
v. SARVIS,A10A0538, A10A0539.
The issue presented in these appeals is whether, under recently amended OCGA § 51-12-33, a trier of fact is required to apportion its award of damages among multiple liable defendants when the plaintiff bears no fault.
The Court held: "It is clear from that subsection's plain language that the legislature did not intend for apportionment to be limited to those cases wherein the plaintiff was to some degree at fault."
The Court went on to hold that:
In accordance with the legislature's unambiguous language in OCGA § 51-12-33 (b), we hold that where damages are to be awarded in an action brought against more than one person for injury to person or property — whether or not such damages must be reduced pursuant to OCGA § 51-12-33 (a) — the trier of fact "shall . . . apportion its award of damages among the persons who are liable according to the percentage of fault of each person."[ 15 ] Had the legislature intended for subsection (b) of OCGA § 51-12-33 to be triggered only upon a reduction of damages pursuant to subsection (a) of that Code section, it could have so stated; but it did not impose any such prerequisite.
Find it here.
Diovan, Avapro and Cozaar (and other) get FDA Review
Just a short time after a meta-analysis suggested angiotensin receptor blockers (ARBs) for hypertension may increase cancer risk, the FDA has said it will conduct a safety review.
The agency emphasized that patients now receiving these agents may stay on them and that physicians could write new prescriptions.
The studies included data on four of the seven available ARB agents -- losartan (Cozaar), candesartan (Atacand), telmisartan (Micardis), and valsartan (Diovan). The other three ARBs now on the market are irbesartan (Avapro), olmesartan (Benicar), and eprosartan (Teveten).
Another 12 products contain one of these agents in combination with other antihypertensives, most commonly a hydrochlorothiazide, according to the FDA.
Source.
The agency emphasized that patients now receiving these agents may stay on them and that physicians could write new prescriptions.
The studies included data on four of the seven available ARB agents -- losartan (Cozaar), candesartan (Atacand), telmisartan (Micardis), and valsartan (Diovan). The other three ARBs now on the market are irbesartan (Avapro), olmesartan (Benicar), and eprosartan (Teveten).
Another 12 products contain one of these agents in combination with other antihypertensives, most commonly a hydrochlorothiazide, according to the FDA.
Source.
Sunday, July 18, 2010
Oil Spill and the Gulf (Florida)
I will tell you that folks are waking up to the nightmare every day. It's quite a sight to see on the beaches- volunteers and workers walking in Seagrove Beach, empty (thank goodness) bags to pick up tar balls. For most of the time, nothing on the beach but perhaps sun tan oil. That, plus an endless stream of 4 wheel vehicles of workers looking for something to do.
Keep the gulf in your prayers.
FDA and bazter Pump Recall
Image via CrunchBaseThe orders require Baxter to ship replacements or issue refunds for affected products and continue to provide batteries, spare parts, and service for devices held by customers with certificates of medical necessity.
Additionally, Baxter must maintain service of pumps held by customers with the certificate for 24 months following today's order or until the customer has made use of a replacement product.
The recall was issued in early May, when the FDA required Baxter to recall and destroy the fluid delivery pumps. The announcement came after the agency said in April it received 56,000 adverse event reports -- including 500 deaths -- related to infusion pump use from all manufacturers from 2005 to 2009.
More here.
Florida/Georgia Avandia News: Restrict, but don't Recall Avandia
Avandia survives another round of FDA meetings. An FDA panel panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the FDA should do. Sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.
Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.
Source.
Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.
Source.
Zelnorm: Claims Settle
Image via WikipediaNovartis had suspended U.S. sales of Zelnorm in 2007 at the request of the U.S. Food and Drug Administration because a safety analysis found it increased the risk of heart attack, stroke and chest pain, compared with placebo.
Zelnorm, which first went on sale in 2001, was approved to treat irritable bowel syndrome with constipation. It had sales of $561 million in 2006, the last full year before its withdrawal.
The withdrawal sparked a number of lawsuits. Novartis said in its earnings release it's a defendant in about 135 cases brought in U.S. and Canadian courts.
Monday, July 12, 2010
Avandia: FDA Reviewers Suggest the Drug's Withdrawal
Avandia should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.Rosiglitazone is no more effective at improving glycemic control in type 2 diabetes than pioglitazone and provides no known unique health benefits, and while both drugs increase the risk of congestive heart failure, rosiglitazone's effect is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday
In the FDA reviewers' analysis, the hazard ratios with rosiglitazone versus placebo were:
In the FDA reviewers' analysis, the hazard ratios with rosiglitazone versus placebo were:
- 1.42 for MI (95% lower confidence limit 0.93, 95% upper confidence limit 2.16)
- 0.96 for strokes (95% LCL 0.60, 95% UCL 1.54)
- 0.95 for cardiovascular death (95% LCL 0.57, 95% UCL 1.60)
- 1.13 for major adverse cardiovascular events (95% LCL 0.85, 95% UCL 1.50)
Thursday, July 01, 2010
SCOTUS: Case versus Pfizer involving Non Citizens may Proceed
The US Supreme Court declined to take up a case examining whether drug giant Pfizer could be sued in an American court for allegedly conducting nonconsensual drug tests on 200 Nigerian children in 1996. The action allows the case to move toward a trial.
The suit was filed under the Alien Tort Statute (ATS), which empowers federal judges to hear civil lawsuits filed by non-US citizens for violations of the “law of nations.”
Lawyers for Pfizer denied that the Nigeria experiments were conducted without the consent and knowledge of the children and their guardians. In addition, the lawyers argued that the children’s case should be thrown out of court because the alleged drug experiments are not the precise type of international law violation covered under the ATS.
What made the high court appeal potentially significant is that the Supreme Court has declared that foreign plaintiffs may rely on the ATS to file lawsuits, but only in a few limited circumstances. The high court has not yet identified precisely which few cases may be brought and which may not. Pfizer v. Abdullahi (09-34) offered an opportunity for the justices to offer guidance and clarification.
Source.
The suit was filed under the Alien Tort Statute (ATS), which empowers federal judges to hear civil lawsuits filed by non-US citizens for violations of the “law of nations.”
Lawyers for Pfizer denied that the Nigeria experiments were conducted without the consent and knowledge of the children and their guardians. In addition, the lawyers argued that the children’s case should be thrown out of court because the alleged drug experiments are not the precise type of international law violation covered under the ATS.
What made the high court appeal potentially significant is that the Supreme Court has declared that foreign plaintiffs may rely on the ATS to file lawsuits, but only in a few limited circumstances. The high court has not yet identified precisely which few cases may be brought and which may not. Pfizer v. Abdullahi (09-34) offered an opportunity for the justices to offer guidance and clarification.
Source.
Effient on the FDA Radar
Image via WikipediaThe FDA released its quarterly list of early investigations into health problems reported with various drugs on Wednesday.
On the list, the agency said it was probing cases of thrombotic thrombocytopenic purpura (TTP) in patients treated with Effient, a blood thinner from Lilly and Daiichi Sankyo. TTP is a rare but potentially fatal blood disorder.
Effient's makers have seen one, or "possibly two," reports of TTP with the drug since its approval a year ago, Lilly spokeswoman Tammy Hull said. No cases were recorded in clinical trials, she said.
Source.
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