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.

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?

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.

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.

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.

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:

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.

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.

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."

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.

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?

Procrit, Aranesp and Epogen News: Congressman Says Stop the Ads

Congressman John Dingel has asked both Johnson & Johnson and Amgen Inc. to stop consumer advertising of their anemia medications for cancer patients until May 2007 or until the FDA wraps up an ongoing review.

Aranesp and Epogen (Amgen) and Procrit (J&J) have both been in the news over a recent clinical trial.

There is a planned May 10, 2007 FDA advisory panel meeting to determine among other things the black box warnings planned for the drugs. what, if any, additional measures need be taken to protect the public from unnecessary risks to human life from these products,'' Dingell said in the March 20 letters. His office confirmed the letters were sent today.

Procrit, Epogen and Aranesp are engineered versions of a protein called erythropoietin, or EPO. EPO promotes the production of red-blood cells, which carry oxygen through the blood. EPO has long been discussed in pro cycling circles. Go here for an article titled "Spinning in their Graves." Lance Armstrong had been given Epogen during his cancer battle.

The recent study suggested that blood clots, strokes and heart attacks may be linked to higher doses of these medications, a claim denied by the drugmakers.

Black Box Warnings for Procrit, Eopgen and Aranesp

From several sources:

Last week the the FDA issued a warning that using of an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin to raise hemoglobin may be linked to serious and life-threatening side-effects or even death.

What is particularly noteworthy is that the FDA has stated there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) might increase energy or ease fatigue in patients that face cancer therapy.

What does the warning say?

That persons taking any of the stated drugs use the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion

• Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
• Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
• Patients treated before surgery with epoetin alfa to reduce red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.

For more, go here.

Katrina: Gator Basketball Tours 9th Ward

From time to time I post about my alma mater, The University of Florida. This past weekend, the basketball team was in New Orleans, and the players and coaches toured the area devastated by the storm and its flooding.

One player, Joakim Noah, said this: "It was an experience I'll never forget." "It's been a year-and-a-half since Katrina, but in some areas, it looks like the hurricane hit just last week." He also commented, "It makes you wonder, 'Do we really care?' "

For more, go here. The link takes you to the Sunday 3/18/07 Orlando Sentinel article.

My comment: The answer to your last question is NO. America does not care. Many individuals, churches and volunteers, and I do, but the insurers, the politicians, the true titans of business do not. It may as well be Bosnia.

Shameful.

Vioxx Verdict: $20 Million in Humeston

In New Jersey, the Humeston case was retried, and today (3/12/07) the verdict came back: The jury concluded that Vioxx contributed to an Idaho postal worker Mike Humeston's heart attack, and awarded him and his wife $20 million in damages. The jurors awarded Humeston $18 million in compensatory damages and gave another $2 million to his wife, Mary.

The punitive damages phase begins this week.

My comment: Chris Seeger vowed that a retrial would vindicate his clients, and it has.

Actos (Diabetes Drug): Blamed for Broken Bones

Actos is a diabetes drug introduced in 1999. According to a recent study sponsored by Takeda, the drug's maker, it found incidences of fractures when comparing Actos to a placebo.

Women using Actos had about 1.9 broken bones for every 100 patient-years studied, compared with 1.1 broken bones for 100 patient-years in the other women. The data represented almost 12,000 patient-years for each group.

Most of the fractures involved the hands, wrists, forearms, feet, ankles and legs. Takeda said it doesn't know what caused these broken bones and is still evaluating the findings.

For more, go here.

Vioxx: Texas Garza Verdict Stands (For Now)

Leonel Garza's Vioxx verdict in Texas last year for $7.75 million will not be retried.

A State Court Judge did not rule on a pending Motion for New Trial filed by Merck. The Motion as a seventy five day time frame in which a Judge could rule on it. By not ruling, it has been effectively denied.

I am certain that there will be an appeal.

Seroquel and Zyprexa: Off Label Use Rampant?

Seroquel prescriptions for off-label use are growing. According to a recent report in Bloomberg,

Prescriptions for Seroquel and Zyprexa, generated more than fourteen billion dollars in total sales last year. According to doctors, the drugs have been prescribed to patients with Alzheimer's disease as well as to teenagers with emotional conditions.

Nearly half of Seroquel prescriptions last year were allegedly for disorders for which AstraZeneca has yet to gain regulatory approval. It is, however, legal for doctors to administer drugs for certain unapproved medical conditions. Companies are prohibited from marketing products to doctors for uses not yet cleared by the U.S. Food and Drug Administration in Washington or by regulators in other countries.

Consequences for off-label scripts? Half a dozen states have filed suit against Eli Lilly, claiming in those lawsuit papers that the drugmaker (and others) failed to disclose the risks of side effects caused by the drug and promoted their use to treat conditions for which they were not approved.


For more, go here.

I Want Your Motion in Limine!

If you have a Motion in Limine that you are willing to share, would you send it to me? I would like any that you believe are helpful in your injury cases. Any Court. I plan to publish excerpts here, and any additional comment you may have regarding the contents of it.

My email is to the right. Any format. Are you willing?

Talk Like a Lawyer?

Trial attorneys and litigators of nearly every stripe will often tout how important it is to speak plainly, and how it is better to avoid legal jargon. Most unfortunately do not practice what is preached.

I'm reviewing a deposition transcript this morning and I'm getting a headache. Defense counsel has asked these gems: "Remembering that you are under oath, please describe the nature and permanency of the alleged personal injuries suffered by you in this negligence action." The reply was, "I don't understand what you just asked me."

Another: "What if any exacerbation of any pre-existing emotional condition are you claiming as a result of this negligence action?" His reply was that there was no "exasperation."

Have I described you?

Long ago I learned one basic question that I now always ask. Lefferts Mabie always began questioning with "tell us who you are." Better than, "please state your full legal name for the record."

Tamiflu: Side Effects Causing Concern?

The influenza drug Tamiflu may cause fatal side effects -- according to news from Japan. Two people who took it fell to their deaths in February of 2007.

The Health Ministry of Japan issued warnings that influenza patients may show psychiatric problems.

To the surprise of no one, Roche - the maker of the drug - denied a link between the medication and the deaths

For more, go here.