The FDA is adding ‘black box’ warnings to all prescription and over-the-counter pain relievers – even to naproxen.
High doses of Advil (800 mg three times a day) and Voltaren (75 mg twice daily) were associated with rates of heart attack that were 51 percent and 63 percent higher than a placebo. An analysis of a large number of trials comparing COX-2 inhibitors to other NSAIDs found similar results – that Voltaren was estimated to increase vascular risk by about 70 percent over Aleve.
You can read more here.
Sunday, April 29, 2007
Coming to Your MP3 Player: FDA Podcasts
The FDA is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information.
The service is part of the agency's effort to speed up communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. You can subscribe to them for free at:
http://www.fda.gov/cder/drug/podcast/default.htm.
The service is part of the agency's effort to speed up communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. You can subscribe to them for free at:
http://www.fda.gov/cder/drug/podcast/default.htm.
Thursday, April 26, 2007
Vioxx News: Plunkett Seeks Trial #3
A woman whose husband died of a heart attack because of Vioxx (she claims) wants a retrial.
Evelyn Irvin Plunkett should get a third federal trial of her lawsuit claiming that the once-popular painkiller caused her first husband's fatal heart attack because a cardiologist who testified for manufacturer Merck & Co. did not reveal that his certification as a physician had lapsed. The first trial was a hung jury, and the second trial was a verdict for Merck.
For more, go here.
Evelyn Irvin Plunkett should get a third federal trial of her lawsuit claiming that the once-popular painkiller caused her first husband's fatal heart attack because a cardiologist who testified for manufacturer Merck & Co. did not reveal that his certification as a physician had lapsed. The first trial was a hung jury, and the second trial was a verdict for Merck.
For more, go here.
I'm In Love
Well, not in love, really. More like "I love this service." A company called Mediconnect, whose mission is stated on its site: "MediConnect offers secure online record retrieval using state-of-the art technology, a unique patented process, and individualized yet industry-leading service; all at minimal expense to you. "
I vowed in 2007 to use a records retrieval system like this, and generally had no complaints. Last week I had an urgent need to obtain a medical record from a hospital in another state. It was a rush item. One that if handled in office would likely take at least ten to fourteen days, multiple fax transmissions and multiple calls.
I used Mediconnect, ordered the records on a Thursday afternoon, and by Monday had the records in hand (via PDF to my email). Less than two business days. By Tuesday it was in the hands of an adjuster, and late yesterday the matter was resolved.
The best part about this service (and there are surely others) was: No staff complaining about having to go into crisis mode to obtain the records, less cost than staffing, no concerns by me over whether or not it was birddogged properly, and fast turn around. All for under $30 plus the costs of the records.
You owe it to yourself to give it a look, in my humble opinion.
I vowed in 2007 to use a records retrieval system like this, and generally had no complaints. Last week I had an urgent need to obtain a medical record from a hospital in another state. It was a rush item. One that if handled in office would likely take at least ten to fourteen days, multiple fax transmissions and multiple calls.
I used Mediconnect, ordered the records on a Thursday afternoon, and by Monday had the records in hand (via PDF to my email). Less than two business days. By Tuesday it was in the hands of an adjuster, and late yesterday the matter was resolved.
The best part about this service (and there are surely others) was: No staff complaining about having to go into crisis mode to obtain the records, less cost than staffing, no concerns by me over whether or not it was birddogged properly, and fast turn around. All for under $30 plus the costs of the records.
You owe it to yourself to give it a look, in my humble opinion.
Monday, April 23, 2007
Pergolide's Withdrawal Impacts 10,000 ...
Horses. Yes you read that right. An estimated 10,000 horses are currently prescribed pergolide in the United States.
Sources include: Thehorse.com
The news that Pergolide (treats symptoms of Parkinson's disease) will be withdrawn from the market has a direct effect on ... horses.
Pergolide (Permax) is in a class of medications called dopamine agonists and is an important med used to control the symptoms of Cushing's disease, a pituitary disorder found in horses.
Current drug rules in the United States will not allow its import and use on animals. Nearly 10,000 horses are prescribed this drug.
Sources include: Thehorse.com
Wednesday, April 18, 2007
14,000 Less Cases of Breast Cancer B/C of less HRT Use?
In 2002, Wyeth (maker of Prempro and Premarin) was hit with the news that claimed a link between breast cancer and the drugs it made for Hormone Replacement Therapy.
According to a recent study, as noted by among others Bloomberg, the rate of women diagnosed with breast tumors fell in 2003 and did not change in 2004, according to a report issued by researchers from M.D. Anderson Cancer Center in Houston.
Millions of menopausal women gave up on the HRT drugs affter the 2002 study was issued.
``The missing cancers, the ones that don't seem to have occurred, are the kinds that are responsive to hormone therapy,'' said the lead author, Peter Ravdin, an investigator at the cancer center, in a telephone interview. ``The decline was not a one-year wonder, a short-lived anomaly.''
Stopping hormone-replacement therapy may have led to 14,000 fewer breast cancers in 2003 than a year earlier, according to Donald Berry, head of quantitative sciences at M.D. Anderson.
What is notable in the article is this: Incidences of breast cancer rose about 0.5 percent a year throughout the 1990s according to the researchers. The last two years? A decline of more than 8 percent.
According to a recent study, as noted by among others Bloomberg, the rate of women diagnosed with breast tumors fell in 2003 and did not change in 2004, according to a report issued by researchers from M.D. Anderson Cancer Center in Houston.
Millions of menopausal women gave up on the HRT drugs affter the 2002 study was issued.
``The missing cancers, the ones that don't seem to have occurred, are the kinds that are responsive to hormone therapy,'' said the lead author, Peter Ravdin, an investigator at the cancer center, in a telephone interview. ``The decline was not a one-year wonder, a short-lived anomaly.''
Stopping hormone-replacement therapy may have led to 14,000 fewer breast cancers in 2003 than a year earlier, according to Donald Berry, head of quantitative sciences at M.D. Anderson.
What is notable in the article is this: Incidences of breast cancer rose about 0.5 percent a year throughout the 1990s according to the researchers. The last two years? A decline of more than 8 percent.
Motion in Limine: Low/Minor Impact Complaint - Exclude Photographs
Body of the Motion:
The evidence of the extent or amount of property damage is irrelevant.
Because the fact of the collision and the damage to the vehicles involved are not at issue in this case, photographs of the vehicles, property damage invoices, or other evidence regarding the extent or amount of property damage is not relevant. Georgia Rule of Evidence O.C.G.A. §24-2-1 defines relevant evidence as “evidence that relates to the questions being tried by the jury and bear upon them either directly or indirectly. Evidence that fails to meet that definition is irrelevant and is inadmissible. O.C.G.A. §24-2-1.
The Defendant has admitted causing the collision. Additionally, neither party has made a claim for property damage in this suit. Because neither the fact of the collision nor the amount of damage to the vehicles is at issue in this case, evidence discussing such issues does not make any fact of consequence more or less probable.
The extent or amount of property damage lacks the requisite foundation and testimony.
Because the fact of the collision and the damage to the vehicles are not issues in this case, the only conceivable purpose for evidence of the extent or amount of property damage is to invite the jury to speculate on the issue of causation (or absence thereof). To prove or disprove causation, however, the party must present competent evidence through competent witnesses after a proper foundation has been laid for the witnesses’ testimony.
The defense has not designated any expert witnesses to testify as to causation or lack thereof. Instead, the defense will simply refer to the photographs or repair invoices for the vehicles and argue that the jury use their “common sense” and find that Plaintiff’s injuries could not have been caused in this collision. Georgia courts require testimony, not argument, to prove or disprove causation and damages.
Use of evidence of property damage in this manner requires a proper foundation be laid through an expert witness. Interpreting the force of an impact from vehicle photographs and then assessing the likelihood of injury from such impact are tasks that can only be attempted by experts. Such matters are not within jurors’ realm of common sense.
For example, the issue of determining the force of the impact in a two-vehicle collision has been debated in scientific literature for years.Determining how much energy was transferred from the object vehicle to the target vehicle alone is extremely difficult to accomplish because most of the vehicle crash tests are conducted with a vehicle and fixed object (rather than between two vehicles).
Furthermore, most of the crash tests are performed at speeds exceeding 30 m.p.h., therefore, making it virtually impossible to extrapolate the crush values to lower speed collisions. Lastly, vehicles vary considerably in their ability to absorb certain impacts without showing damage. In fact, the same vehicle may show little damage after one type of impact, but extensive damage from another type of impact.
Even if it were possible to determine how much energy was transferred from one car to another, it is usually impossible to then ascertain exactly how much energy was transferred to the occupant of the target vehicle (as opposed to how much energy was absorbed by the vehicle). Assuming we could compute how much energy from the object vehicle reached the occupant, we would then need to know how it caused the occupant to move. To calculate this, we would need to know things like how the occupant was seated, their head position relative to the head rest and whether their head was turned. These computations can only be made by a biomechanical expert or someone with biomechanical training.
Discovery has closed, and there has not been a designation of an expert on this issue. Many are correctly finding that such evidence is not admissible when it is not accompanied by supporting expert testimony to establish an adequate foundation. See Davis v. Maute, 770 A.2d 36 (Del. 2001) (reversible error to admit evidence of property damage and allow counsel to argue serious injuries could not have resulted from “minor” collision).
The Davis court correctly found: As a general rule, a party in a personal injury case may not directly argue that the seriousness of personal injuries from a car accident correlates to the extent of the damage to the cars, unless the party can produce competent expert testimony on the issue. Absent such testimony, any inference by the jury that minimal damage to the Plaintiff’s car translates into minimal personal injuries to the Plaintiff would necessarily amount to unguided speculation. Davis, 770 A.2d at 42. The Davis holding was reaffirmed by the Delaware Supreme Court in the case of Eskin v Carden, 842 A. 2d 1222 (Del. 2004). See also, Brenman v. Demello, 383 N.J.Super. 521, 892 A.2d 741 (N.J.Super.A.D.,2006).
Thanks to Glenn Loewenthal, Esq.
The evidence of the extent or amount of property damage is irrelevant.
Because the fact of the collision and the damage to the vehicles involved are not at issue in this case, photographs of the vehicles, property damage invoices, or other evidence regarding the extent or amount of property damage is not relevant. Georgia Rule of Evidence O.C.G.A. §24-2-1 defines relevant evidence as “evidence that relates to the questions being tried by the jury and bear upon them either directly or indirectly. Evidence that fails to meet that definition is irrelevant and is inadmissible. O.C.G.A. §24-2-1.
The Defendant has admitted causing the collision. Additionally, neither party has made a claim for property damage in this suit. Because neither the fact of the collision nor the amount of damage to the vehicles is at issue in this case, evidence discussing such issues does not make any fact of consequence more or less probable.
The extent or amount of property damage lacks the requisite foundation and testimony.
Because the fact of the collision and the damage to the vehicles are not issues in this case, the only conceivable purpose for evidence of the extent or amount of property damage is to invite the jury to speculate on the issue of causation (or absence thereof). To prove or disprove causation, however, the party must present competent evidence through competent witnesses after a proper foundation has been laid for the witnesses’ testimony.
The defense has not designated any expert witnesses to testify as to causation or lack thereof. Instead, the defense will simply refer to the photographs or repair invoices for the vehicles and argue that the jury use their “common sense” and find that Plaintiff’s injuries could not have been caused in this collision. Georgia courts require testimony, not argument, to prove or disprove causation and damages.
Use of evidence of property damage in this manner requires a proper foundation be laid through an expert witness. Interpreting the force of an impact from vehicle photographs and then assessing the likelihood of injury from such impact are tasks that can only be attempted by experts. Such matters are not within jurors’ realm of common sense.
For example, the issue of determining the force of the impact in a two-vehicle collision has been debated in scientific literature for years.Determining how much energy was transferred from the object vehicle to the target vehicle alone is extremely difficult to accomplish because most of the vehicle crash tests are conducted with a vehicle and fixed object (rather than between two vehicles).
Furthermore, most of the crash tests are performed at speeds exceeding 30 m.p.h., therefore, making it virtually impossible to extrapolate the crush values to lower speed collisions. Lastly, vehicles vary considerably in their ability to absorb certain impacts without showing damage. In fact, the same vehicle may show little damage after one type of impact, but extensive damage from another type of impact.
Even if it were possible to determine how much energy was transferred from one car to another, it is usually impossible to then ascertain exactly how much energy was transferred to the occupant of the target vehicle (as opposed to how much energy was absorbed by the vehicle). Assuming we could compute how much energy from the object vehicle reached the occupant, we would then need to know how it caused the occupant to move. To calculate this, we would need to know things like how the occupant was seated, their head position relative to the head rest and whether their head was turned. These computations can only be made by a biomechanical expert or someone with biomechanical training.
Discovery has closed, and there has not been a designation of an expert on this issue. Many are correctly finding that such evidence is not admissible when it is not accompanied by supporting expert testimony to establish an adequate foundation. See Davis v. Maute, 770 A.2d 36 (Del. 2001) (reversible error to admit evidence of property damage and allow counsel to argue serious injuries could not have resulted from “minor” collision).
The Davis court correctly found: As a general rule, a party in a personal injury case may not directly argue that the seriousness of personal injuries from a car accident correlates to the extent of the damage to the cars, unless the party can produce competent expert testimony on the issue. Absent such testimony, any inference by the jury that minimal damage to the Plaintiff’s car translates into minimal personal injuries to the Plaintiff would necessarily amount to unguided speculation. Davis, 770 A.2d at 42. The Davis holding was reaffirmed by the Delaware Supreme Court in the case of Eskin v Carden, 842 A. 2d 1222 (Del. 2004). See also, Brenman v. Demello, 383 N.J.Super. 521, 892 A.2d 741 (N.J.Super.A.D.,2006).
Thanks to Glenn Loewenthal, Esq.
Epogen Study: Drug was a Profit Center?
From Forbes and JAMA:
Kidney dialysis centers run as for profit businesses (such as Davita) administered significantly more of the anti-anemia drug Epogen than did not-for-profit dialysis centers, according to JAMA in a recent article.
The authors of the JAMA article ("Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis") reviewed Medicare claims data to examine Epogen dosage for nearly 160,000 dialysis patients in December 2004. The authors found that the for profit centers used an average dose of Epogen, also known as epoetin, that was 20,838 units per week--16% higher than the average dose at nonprofit facilities.
Recently the FDA issued an advisory warning that epoetin and darbepoetin (erythropoiesis-stimulating agents [ESAs]) result in an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain hemoglobin at a certain rate.
In the same JAMA issue, there is an editorial that notes the 2004 Medicare reimbursement rate of $10 per 1,000 units of Epogen resulted in a $1,700 a year per patient higher expense for the higher average dose.
What to me is significant is that JAMA appears to have found problems with Medicare reimbursement for dialysis treatment. According to the data, a large portion of the 335,000 kidney failure patients here who receive dialysis are covered by Medicare. One source is here.
Medicare will reimburses dialysis centers directly for this treatment at a fixed amount. But reimbursement for the use of Epogen is not capped; instead, it is based on the amount of the drug that is used. Medicare spends more money on Epogen--nearly $2 billion--than on any other drug.
According to Forbes and others, a Morgan Stanley report estimated that dialysis chains made 25% of their profits on the Epogen spread.
Kidney dialysis centers run as for profit businesses (such as Davita) administered significantly more of the anti-anemia drug Epogen than did not-for-profit dialysis centers, according to JAMA in a recent article.
The authors of the JAMA article ("Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis") reviewed Medicare claims data to examine Epogen dosage for nearly 160,000 dialysis patients in December 2004. The authors found that the for profit centers used an average dose of Epogen, also known as epoetin, that was 20,838 units per week--16% higher than the average dose at nonprofit facilities.
Recently the FDA issued an advisory warning that epoetin and darbepoetin (erythropoiesis-stimulating agents [ESAs]) result in an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain hemoglobin at a certain rate.
In the same JAMA issue, there is an editorial that notes the 2004 Medicare reimbursement rate of $10 per 1,000 units of Epogen resulted in a $1,700 a year per patient higher expense for the higher average dose.
What to me is significant is that JAMA appears to have found problems with Medicare reimbursement for dialysis treatment. According to the data, a large portion of the 335,000 kidney failure patients here who receive dialysis are covered by Medicare. One source is here.
Medicare will reimburses dialysis centers directly for this treatment at a fixed amount. But reimbursement for the use of Epogen is not capped; instead, it is based on the amount of the drug that is used. Medicare spends more money on Epogen--nearly $2 billion--than on any other drug.
According to Forbes and others, a Morgan Stanley report estimated that dialysis chains made 25% of their profits on the Epogen spread.
Sunday, April 15, 2007
Gov. Corzine: Not Buckled
The gothamist.com has a well done graphic showing layout of the SUV in which New Jersey Governor Corzine was a front seat, unbuckled passenger. By now most know that Corzine suffered severe injuries in a car wreck last week. No seatbelt. What was he thinking?
Friday, April 13, 2007
Listerine Recalls 4 million bottles of mouthwash
Late yesterday, Johnson and Johnson recalled four million bottles of its Listerine agent Cool Blue mouthwash. This applies to the "glacier mint" and "bubble blast" flavors.
The company says tests showed it is contaminated with microorganisms. This could make some people sick who have weakened immune systems. However, there have been no reports of sickness so far.
For more, go the website: www.agentcoolblue.com.
The company says tests showed it is contaminated with microorganisms. This could make some people sick who have weakened immune systems. However, there have been no reports of sickness so far.
For more, go the website: www.agentcoolblue.com.
Wednesday, April 11, 2007
Adolor's Bowel Drug "Entereg" also linked to Heart Disease
In the wake of last week's news regarding Zelnorm and the decision to voluntarily yank it from the market, GlaxoSmithKline and Adolor Corp. have said that the experimental drug Adolor to treat constipation due to opioid painkillers was linked to higher risk of heart attacks and other serious heart problems, fractures and skin cancers in a late-stage trial.
The companies said the negative findings came from a year-long Phase III study of Entereg involving 805 patients experiencing bowel dysfunction as a result of taking opioids for treatment of chronic non-cancer pain.
For more, go here.
The companies said the negative findings came from a year-long Phase III study of Entereg involving 805 patients experiencing bowel dysfunction as a result of taking opioids for treatment of chronic non-cancer pain.
For more, go here.
Tuesday, April 10, 2007
Do you use the term "corpus" daily?
As the Anna Nicole Smith baby daddy issue flogs humanity from every available media outlet today (DNA results released) , I heard an exchange on a local Atlanta station. The newsman on that station mentioned the DNA results, then turned to the station's "go to" legal expert for comment.
The legal eagle was asked words to the effect of, "what does this mean for the [Anna Nicole Smith] baby's finances in the future?" The lawyer's reply? He said, "the corpus may be encroached upon by application" in the future for the child's benefit. A cutaway to the weather followed.
75% of the listeners just said "huh?" Apparently it's too much to ask an attorney to speak plainly now on air.
The legal eagle was asked words to the effect of, "what does this mean for the [Anna Nicole Smith] baby's finances in the future?" The lawyer's reply? He said, "the corpus may be encroached upon by application" in the future for the child's benefit. A cutaway to the weather followed.
75% of the listeners just said "huh?" Apparently it's too much to ask an attorney to speak plainly now on air.
Blogging: Heavy Handed, Self Appointed Blog Cop Wants Rules
I had to laugh as I read the news that Tim O'Reilly - a person the average man on the street couldn't tell you one thing about - has decided that blogs and bloggers must be muzzled.
Nonsense. The self important snob forgets that the import of anonymous speech rises geometrically in proportion to the growth of big government. Those who seek to control such speech are in my humble opinion dangerous to the very foundation of free speech.
From various sites:
Take a look around, Tim. In fact, why not take a moment to check out the history of our nation's leaders? If you bothered to do so, you would know Abraham Lincoln and Benjamin Franklin both published anonymous letters for political purposes. In fact, Franklin used anonymous letters for political purposes up to his death. (Source here).
This self important but likely well meaning attempt to muzzle bloggers should cease.
Nonsense. The self important snob forgets that the import of anonymous speech rises geometrically in proportion to the growth of big government. Those who seek to control such speech are in my humble opinion dangerous to the very foundation of free speech.
From various sites:
Last week, Tim O’Reilly, a conference promoter and book publisher who is credited with coining the term Web 2.0, began working with Jimmy Wales, creator of the communal online encyclopedia Wikipedia, to create a set of guidelines to shape online discussion and debate.
Chief among the recommendations is that bloggers consider banning anonymous comments left by visitors to their pages and be able to delete threatening or libelous comments without facing cries of censorship. (Source, here).
Take a look around, Tim. In fact, why not take a moment to check out the history of our nation's leaders? If you bothered to do so, you would know Abraham Lincoln and Benjamin Franklin both published anonymous letters for political purposes. In fact, Franklin used anonymous letters for political purposes up to his death. (Source here).
This self important but likely well meaning attempt to muzzle bloggers should cease.
Monday, April 09, 2007
FDA: Zellnorm Withdrawn
Just a week or so ago, the FDA asked that the marketing of Zelnorm end, based on findings suggesting increased risks of serious cardiovascular adverse events (heart problems) associated with that drug. The drug was voluntarily withdrawn.
The drug was often used to treat IBS and significant abdominal pain, Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment.
For more, go here.
The drug was often used to treat IBS and significant abdominal pain, Zelnorm is the only FDA-approved therapy for the constipation-causing form of the ailment.
For more, go here.
Sen. Grassley: Show me the Zyprexa documents
The Republican Senator from Iowa wants Eli Lilly to produce documents that may suggest Lilly didn't play fair in touting Zyprexa, often used to treat schizophrenia and bipolar disorder.
Senator Grassley wants Lilly to provide "e-mails, letters, reports" and other internal documents relating to Zyprexa. Earlier this year, a USDCT judge ruled on the dissemination of documents that were the focus of New York Times articles reporting that Lilly knowingly understated the risks of its drug, and touted it for unapproved uses. You can find the NYT article here.
From the NYT: "Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004."
Senator Grassley wants Lilly to provide "e-mails, letters, reports" and other internal documents relating to Zyprexa. Earlier this year, a USDCT judge ruled on the dissemination of documents that were the focus of New York Times articles reporting that Lilly knowingly understated the risks of its drug, and touted it for unapproved uses. You can find the NYT article here.
From the NYT: "Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004."
Wednesday, April 04, 2007
Practicing Law: My New Office
Posting has been a bit light for me lately, as I have left my prior firm and have now opened my own office. Extricating myself from one firm has had issues typical to most, as well as several that are a bit less standard.
Change can come quickly as I have seen. I am quite happy now, more so than I thought possible. I will be writing a bit more as time permits.
Change can come quickly as I have seen. I am quite happy now, more so than I thought possible. I will be writing a bit more as time permits.
Ortho Evra: Drug's Maker Buys "Negative" Domain Names
From Bloomberg:
Johnson & Johnson bought domain names Orthoevrakills.com and Deathbypatch.com according to documents released today in a New Jersey lawsuit. Ortho Evra is a birth control patch currently on the market.
One document from Johnson & Johnson document refers to the purchase of domain names, monitoring blogs and bidding on key search terms about the patch on search engines.
I went to both site, but nothing is up on either one. Perhaps J and J should direct them to a news page inside their main domain?
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