News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injured people.(No advice on this blog, though) mark(at)markzamora.com
Wednesday, December 20, 2006
Season's Greetings 2006
Posting will be very light the rest of the month. The pic above is from one of my favorite towns out west, Crested Butte.
While you work away these next few days, check out streaming music from Mardi Gras Radio.
2007 Resolutions
I know that many people do not make them or keep them. I do. If you are a person who at least tries to come up with a list, I've stumbled across a few posted on blogs out there.
Matt Homan has a number of posts regarding resolutions.
A few around my office are simple in idea but may prove difficult in practice: Move to PDF images of all frequently reviewed documents in a client's file. Accident Reports, for example. In a client directory that should be one of the 'must haves' on a server.
I also resolve to use an online medical records acquisition like Mediconnect on a test basis. One attorney in town swears by it.
More later
Matt Homan has a number of posts regarding resolutions.
A few around my office are simple in idea but may prove difficult in practice: Move to PDF images of all frequently reviewed documents in a client's file. Accident Reports, for example. In a client directory that should be one of the 'must haves' on a server.
I also resolve to use an online medical records acquisition like Mediconnect on a test basis. One attorney in town swears by it.
More later
Monday, December 18, 2006
Zyprexa: Did Drugmaker Hide Risks?
The NYT reports that drugmaker Eli Lilly may have tried to play down the health risks of schizophrenia drug Zyprexa.
The NYT referred to hundreds of internal documents and e-mail messages circulated by employee. The NYT article says that Lilly executives allegedly withheld important information from doctors about Zyprexa's links to obesity and elevated blood sugar, risk factors for diabetes.
The drug company's own published data (according to the Times) showed that nearly thirty percent of patients taking Zyprexa gain more than twenty pounds or more after a year on the drug. Some gained more than 100 pounds.
The documents show Lilly's concern that Zyprexa sales would suffer if the company
was more candid about the drug's risk of causing unmanageable weight gain or diabetes. As expected the company disputes the claims. Lilly through reps said that there is no scientific evidence establishing that Zyprexa causes diabetes.
In an internal document, Lilly employees discussed that the drug was associated with weight gain and possible hyperglycemia, and this would be a threat to the long-term success of the drug. The date of the document was 1999.
The documents were apparently given to the NYT by James Gottstein, a lawyer representing mentally ill patients who is suing the state of Alaska over its efforts to force patients to take psychiatric medicines against their will.
Source - NYT.
The NYT referred to hundreds of internal documents and e-mail messages circulated by employee. The NYT article says that Lilly executives allegedly withheld important information from doctors about Zyprexa's links to obesity and elevated blood sugar, risk factors for diabetes.
The drug company's own published data (according to the Times) showed that nearly thirty percent of patients taking Zyprexa gain more than twenty pounds or more after a year on the drug. Some gained more than 100 pounds.
The documents show Lilly's concern that Zyprexa sales would suffer if the company
was more candid about the drug's risk of causing unmanageable weight gain or diabetes. As expected the company disputes the claims. Lilly through reps said that there is no scientific evidence establishing that Zyprexa causes diabetes.
In an internal document, Lilly employees discussed that the drug was associated with weight gain and possible hyperglycemia, and this would be a threat to the long-term success of the drug. The date of the document was 1999.
The documents were apparently given to the NYT by James Gottstein, a lawyer representing mentally ill patients who is suing the state of Alaska over its efforts to force patients to take psychiatric medicines against their will.
Source - NYT.
Tuesday, December 12, 2006
CLE Conferences
This idea stolen from Idea Surplus Disorder Blog:
Know Your Questions. Seek Your Answers. Never attend a conference without at least three questions you want answered. Never leave until they have been.
I try to have a defined set of areas covered. My biggest gripe when it comes to attorney conferences? I go to hear one person in particular and when I turn to that person's materials ... nothing. When that person speaks, it's half ad libbed and mostly war stories. Two speakers were guilty of this at a recent conference.
The best set of materials at a conference I attended came typed, double spaced, and full of legal citations. The author? An attorney who has been practicing law for less than five years.
Know Your Questions. Seek Your Answers. Never attend a conference without at least three questions you want answered. Never leave until they have been.
I try to have a defined set of areas covered. My biggest gripe when it comes to attorney conferences? I go to hear one person in particular and when I turn to that person's materials ... nothing. When that person speaks, it's half ad libbed and mostly war stories. Two speakers were guilty of this at a recent conference.
The best set of materials at a conference I attended came typed, double spaced, and full of legal citations. The author? An attorney who has been practicing law for less than five years.
Drug Coated Stents: Risk or No?
Drug-coated stents that prop open the arteries of about 3 million people in the U.S. don't increase the risk of heart attack or death when used as labeled but may put patients at risk for blood clots, says the FDA.
In an earth shaking development, Johnson & Johnson - a stent maker - said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.
You can read more here.
In an earth shaking development, Johnson & Johnson - a stent maker - said there is no significant difference in clotting, heart attack or death rates between its stent, the Cypher, and bare metal versions.
You can read more here.
Ketek (Antibiotic): Facing the Music before the FDA
The FDA first approved Ketek in April 2004 for the treatment of pneumonia, sinusitis and bronchitis. Not long after that, the Public Citizen Health Research Group, added the antibiotic to its list of "do not use" drugs. Public Citizen cited reports of liver toxicity, serious vision problems and the possibility of heart rhythm disturbances.
Later this week (Thursday and Friday) the FDA convenes a joint meeting of its Anti-Infective Drugs and its Drug Safety and Risk Management advisory committees to discuss what it calls Ketek's overall benefit-to-risk considerations. See FDA information here.
I think that the FDA will order the drug maker to strenghthen its warnings regarding the drug.
Canada has issued a warning regarding this drug:
Health Canada is advising Canadians about a possible link between use of the antibiotic Ketek and potentially serious liver problems.
There have been international reports of patients using Ketek who experienced liver failure requiring transplant or resulting in death, although no such cases have been reported in Canada. Ketek (the brand name for telithromycin), which has been marketed in Canada since May 2003, is indicated for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections.
Later this week (Thursday and Friday) the FDA convenes a joint meeting of its Anti-Infective Drugs and its Drug Safety and Risk Management advisory committees to discuss what it calls Ketek's overall benefit-to-risk considerations. See FDA information here.
I think that the FDA will order the drug maker to strenghthen its warnings regarding the drug.
Canada has issued a warning regarding this drug:
Health Canada is advising Canadians about a possible link between use of the antibiotic Ketek and potentially serious liver problems.
There have been international reports of patients using Ketek who experienced liver failure requiring transplant or resulting in death, although no such cases have been reported in Canada. Ketek (the brand name for telithromycin), which has been marketed in Canada since May 2003, is indicated for the treatment of pneumonia, throat and sinus infections and chronic bronchitis, as well as serious or multi-drug resistant infections.
Monday, December 11, 2006
Buy This CD - New Orleans Christmas
I love New Orleans. This year, you can buy a CD with great Christmas music recorded by Big Easy musicians, and a portion of the proceeds go to the Habitat for Humanity Musicians' Village in that city.
New Orleans Christmas, which you can find on Amazon.
You can hear snippets online here.
Much better than those retreads you hear on the radio or Sirius, you will find superb Christmas tunes. Papa Don Vappie, The Dukes of Dixieland, Banu Gibson, and Topsy Chapman provide the auditory feast.
A comment on the web somewhere is apt: "The music is upbeat and will put a smile on the face of the most jaded Scrooge in the group."
Buy it!
Thursday, December 07, 2006
Iraq Study Group: Comprised of Lawyers
Interesting to read the background of the esteemed members of this Iraq Study Group. 8 of the 10 are attorneys. Co Chairs are attorneys.
You can read the text of the press conference here.
"Lawyers" in general are an easy target of politicians, talking heads, and the populace. Until you need one.
You can read the text of the press conference here.
"Lawyers" in general are an easy target of politicians, talking heads, and the populace. Until you need one.
Fen Phen News: PPH Suits Filed
In Philly, suits were filed this week. Renee Tedesco is one plaintiff. She was diagnosed with primary pulmonary hypertension in April of 2007, eight years after she stopped taking Fen Phen. Last month, Tedesco underwent a nine-hour double lung transplant.
Tedesco's lawyer is Alex H. MacDonald. He said he expects Wyeth to argue that fen-phen would not cause severe complications to surface years after the women stopped taking the pills.
Alex MacDonald's first PPH case was extensively detailed in a book by Alicia Mundy title, Dispensing with the Truth, a compelling read regarding the battle over fen phen. I am pretty certain that a read of it will make you angry.
Alex told me that Diane Keaton had purchased the rights to that book, but to date the film adaptation has not gone into production. I had to laugh when he said that he feared the movie the most, because he would point to the screen and say to his kids, "You see that gal up there, that's me!"
For more on the lawsuits, go here.
Tedesco's lawyer is Alex H. MacDonald. He said he expects Wyeth to argue that fen-phen would not cause severe complications to surface years after the women stopped taking the pills.
Alex MacDonald's first PPH case was extensively detailed in a book by Alicia Mundy title, Dispensing with the Truth, a compelling read regarding the battle over fen phen. I am pretty certain that a read of it will make you angry.
Alex told me that Diane Keaton had purchased the rights to that book, but to date the film adaptation has not gone into production. I had to laugh when he said that he feared the movie the most, because he would point to the screen and say to his kids, "You see that gal up there, that's me!"
For more on the lawsuits, go here.
Wednesday, December 06, 2006
Trasylol Information
Angel Reyes has an office in Dallas, Texas, and he recently ran a Trasylol ad.
Bayer has informed the FDA that it had carried out an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol might increase the chance for death, serious kidney damage, congestive heart failure and strokes.
While the FDA conducts its assessment of this new safety study, it is recommended that physicians consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. Doctors should carefully observe patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain.
Trasylol (Generic: Aprotinin), Bayer's injectable drug used to prevent excessive blood loss during heart surgery, doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55%. It is also linked with encephalopathy (degenerative brain diseases). Researchers announced their findings on January 25, 2006 and the study results were published in the New England Journal of Medicine. The study examined 4,374 heart bypass surgery patients at hospitals around the world.
You can see it below:
Bayer has informed the FDA that it had carried out an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol might increase the chance for death, serious kidney damage, congestive heart failure and strokes.
While the FDA conducts its assessment of this new safety study, it is recommended that physicians consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. Doctors should carefully observe patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain.
Trasylol (Generic: Aprotinin), Bayer's injectable drug used to prevent excessive blood loss during heart surgery, doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55%. It is also linked with encephalopathy (degenerative brain diseases). Researchers announced their findings on January 25, 2006 and the study results were published in the New England Journal of Medicine. The study examined 4,374 heart bypass surgery patients at hospitals around the world.
You can see it below:
Southern Trial Lawyers Yearly Mtg: NOLA 2/15-17
The STLA meets again in New Orleans, and let me tell you it will be a good time. Just about 60 days away (almost), and yours truly speaks this year. Topic is Working with the Competition.
It's a pretty fun seminar, informative as well. The muckety mucks have decided that 15 minute presentations are the way to go, and I agree. Also, two hours for lunch! You can linger over at the Palace Cafe on Canal. I have one drink at lunch once a year - at the Palace Cafe during the STLA seminar.
You can find more about it by going here:
http://www.southerntriallawyers.com/html/upcoming_events.html
It's a pretty fun seminar, informative as well. The muckety mucks have decided that 15 minute presentations are the way to go, and I agree. Also, two hours for lunch! You can linger over at the Palace Cafe on Canal. I have one drink at lunch once a year - at the Palace Cafe during the STLA seminar.
You can find more about it by going here:
http://www.southerntriallawyers.com/html/upcoming_events.html
Google Docs/Spreadsheets
Tuesday, December 05, 2006
FDA: Gov't Researcher Faces Charges For Taking $$$ from
A U.S. scientist who has spent time researching Alzheimer's was charged with conflict of interest for accepting $285,000 from drug maker Pfizer Inc. He is being criminally charged.
Pearson Sunderland is the chief of the geriatric psychology branch at the National Institute of Mental Health (NIMH). He faces up to a year in prison and a fine of $100,000 if convicted, prosecutor Rod Rosenstein announced.
Prosecutors said Sunderland, 55, of Chevy Chase, Maryland, accepted the $285,000 in consulting fees and travel expenses from Pfizer without getting required approval from NIH or disclosing the fees to the agency.
Is he the only one? Does any rational person think the FDA is truly independent? That companies do not wield much influence within the walls of the FDA buildings?
Source here.
Pearson Sunderland is the chief of the geriatric psychology branch at the National Institute of Mental Health (NIMH). He faces up to a year in prison and a fine of $100,000 if convicted, prosecutor Rod Rosenstein announced.
Prosecutors said Sunderland, 55, of Chevy Chase, Maryland, accepted the $285,000 in consulting fees and travel expenses from Pfizer without getting required approval from NIH or disclosing the fees to the agency.
Is he the only one? Does any rational person think the FDA is truly independent? That companies do not wield much influence within the walls of the FDA buildings?
Source here.
Southern Football: Video from Gators-Arky Game
Southern Football is really something you need to see live and in person once in your life. As the Gators get ready to play in the National Championship game on 1/8/07, the fun from this past weekend's SEC Championship Game still rings in my ears.
As Florida was in the locker room at halftime of that game, the crowd heard the USC-UCLA score (UCLA pulled the upset). Below is a scene from a men's bathroom - a bathroom with a TV showing the feed of the USC-UCLA game. I was watching the game while sitting in the stands in Atlanta. I borrowed a pair of binoculars and spied the game in a suite.
So here you go (only 27 seconds). Are college football fans in the south nuts? The Gators won of course in a heart pounding way:
I hope some of those guys washed their hands before high fiving others
As Florida was in the locker room at halftime of that game, the crowd heard the USC-UCLA score (UCLA pulled the upset). Below is a scene from a men's bathroom - a bathroom with a TV showing the feed of the USC-UCLA game. I was watching the game while sitting in the stands in Atlanta. I borrowed a pair of binoculars and spied the game in a suite.
So here you go (only 27 seconds). Are college football fans in the south nuts? The Gators won of course in a heart pounding way:
I hope some of those guys washed their hands before high fiving others
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