Did A Drug Company Hide Suicide Link?

From England, this news: GlaxoSmithKline (GSK) attempted to show that the drug Seroxat worked for depressed children despite failed clinical trials.

From last week, you may recall reading on this blog the issues that arise when drugmakers pay or influence medical journals regarding studies or trials of pharma meds.

In this instance, there are claims that GSK-employed ghostwriters influenced "independent" academics.

One email that has surfaced is from a public relations executive working for GSK which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results ... but essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize."

Go here for the full BBC News report.

You could just imagine the shock -- shock I tell you -- whenI read the GSK comment that "GSK utterly rejects any suggestion that it has improperly withheld drug trial information."

$1.5M Jury Verdict in Prempro (HRT) Trial

From late in the day yesterday, a state court jury in Philly found Wyeth's hormone replacement therapy drug known as Prempro responsible for a woman's breast cancer. The verdict mandates that Wyeth pay $1.5 million in compensatory damages. The verdict breakdown: $1M for the woman, $500K for the spouse.

The jury also gets to whack Wyeth with a punitive damages award as well. The punitive damages phase begins this week.

There are nearly 5,000 pending cases, to be quite candid a manageable number of suits for Wyeth.

For more, go here.

Drug Rep Toys Given to Doctors

Interestingly enough, a blog that details the stuff given away. Drug Rep Toys breaks down the goodies, including a maglite.

The profile notes: "If you've gotten something fun or egregious from a drug rep, send me a pic and I'll post it."

The blogger seems to get crappy pens.

Amgen: Bad News Regarding its Anemia Drug

The drug is known as Aranesp. According to recent news from a drug trial, there is an increased risk of death in cancer patients who are not on chemotherapy when taking it.

Aranesp is already approved for use in cancer patients who suffer anemia as a result of their chemotherapy. Amgen wanted to extend this indication to include patients who have anemia from the cancer itself.

Aranesp was already being used off-label for these non-chemotherapy cancer patients. Source here. Another report noted that certain patients in the trial already had "an especially dire prognosis." Source here.

Lucentis (For Macular Degeneration): Increases Stroke Risk

Genentech Inc. alerted eye doctors late last week to the risk of stroke from Lucentis. The drug is used to treat age related macular degeneration. According to AHAF, Age-related macular degeneration (AMD) is a common eye disease that causes deterioration of the macula, the central area of the retina, the paper-thin tissue at the back of the eye where light-sensitive cells send visual signals to the brain.

The company will probably change the drug label soon.

Kugel Mesh Patch Recall

An updated and expanded recall on the Kugel/Bard Mesh Patch.

Products included in the expanded recall are: Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal;Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”; andProduct Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5.”

Back in March the first recall was ordered. “The 'memory recoil ring' that opens the Composix Kugel Mesh Hernia Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Georgia's Litigation Crisis

Yes there is one. State Supreme Court Justice Sears gave her assessment of the Court speech to the Georgia Legislature.

Sorry to disappoint you, but it's not one that has injury cases clogging the system. Divorce cases make up 65% of all civil cases filed in the Georgia State Courts.

More later.

Bring Your Client to Deposition of Difficult Doctor

Spent time going over Dave Swanner's must read blog, sctriallaw.com since my office is undergoing a bit of change and filing more lawsuits. Dave in turn thanked Rodney Pillsbury for suggestions this:

Bring your client to the deposition of a treating physician you think might say negative things about your client. It is much more difficult for a person to that someone is not telling the truth and malingering if that someone is sitting in the room watching. Go here for the link.

One little kernel of advice that I'm using this month when a doctor is deposed, and one I had not heard of in a while.

Pifzer Lawyer: Off Label Marketing Should Be Allowed

Yes you read that right. One lawyer at Pfizer publicly endorsed the right of drug companies to practice off-label marketing under certain conditions.

Arnold Friede is a senior attorney at Pfizer. He has allegedly said that drug companies should be able to advertise unapproved drug uses provided that the info is "truthful and not misleading," and published in a medical journal. He made these comments at a law conference in NYC.

Of course, the FDA prohibits off-label marketing as (how they say down here in the South) "e-legal" or against federal law.

Pifzer itself has paid millions of dollars to settle off label marketing allegation investigations. In his speech at the conference, Friede said, "Peer reviewed journals would be eligible for . . . free speech protection" under a court ruling in which the WLF had sued the FDA. (source here).

What a surprise. In an era where published journals are coming under intense scrutiny for the method in which studies are published, in an era when there are allegations that drug companies are paying the authors to skew results in favor of a certain drug, ("Medical literature contains many articles expressing concern about industrial funding of clinical research") this attorney
apparently would have companies step around the FDA prohibitions?

We must be on guard, and never allow this to happen. The FDA in my view is gross underfunded. Big Pharma wields tremendous influence within the halls of Congress, outspends the FDA by a vast number when compared to the FDA's yearly budget on enforcement, and spends untold millions on industry funded clinical research. The entire process from initial studies to drug roll out needs a complete overhaul, not an end around it, as this attorney seems to suggest.

At Legal Underground: Advanced Depo. Techniques Podcast

Good stuff, and less than fifteen minutes of listening time. Go here to read/listen. Legal Underground.Tips for asserting control at a deposition is the topic, and it is worth the listen.

From The Trial Lawyer Blog

Settlement Agreements and good advice on how to draft confidentiality provisions:

In the recent case Amos v. Commissioner of Internal Revenue, the United States Tax Court stated that "if a settlement agreement lacks express language stating what the amount paid pursuant to that agreement was to settle, the intent of the payor is critical to that determination." 2003 WL 2289795 (U.S. Tax Ct, 2003). As most personal injury attorney's understand, the correct "intent" is very important to memorialize in your settlement documents because IRC §104 (a) (2) provides that "gross income does not include the amount of any damages (other than punitive damages) received (weather by suit or agreement and whether as lump sum or as periodic payments) on account of personal physical injuries or physical sickness."

In Amos, the Court found that the dominant reason that the Defendant, Dennis Rodman, paid plaintiff the settlement amount at issue was to compensate petitioner for his alleged physical injuries arising from an incident involving the two individuals (Dennis Rodman allegedly lost his cool and had an altercation with Amos while Amos was photographing a Bulls Basketball game). However, the Court also found that the settlement was in consideration for several other requirements (mainly a confidentiality agreement). Since the settlement agreement identified those "other requirements" as consideration for the settlement proceeds, the Court determined that the parties did not intend all of the settlement proceeds to be allocated to the component for payment on account of personal physical injuries. As a result, the Court allocated 80% of the settlement as paid in consideration for the other requirements stipulated in the Settlement Agreement. The Court's allocation resulted in 20% of the settlement proceeds being (for non-physical injuries) included in Plaintiff's gross income and not exempt from IRC §61 (the general taxing statute).

For more, go here, and thanks to Matt Garretson.

Anti-Depressants: Older Adults Risk Fragile Bones?

Older adults who take certain anti-depressant drugs may have an increased risk of developing fragile bones.

Tests on a group of Canadians aged 50 or older found those taking selective serotonin reuptake inhibitors (SSRI) had 4 percent less bone mineral density in their hip bones.

At least one doctor says it may make sense to have mineral density test before going on an SSRI, especially if the patient has had a low-impact bone fracture.

For more, go to this source, here.

Vioxx: Philadelphia Plaintiff Drops Pending Case

With a trial date set for five weeks from now, a Plaintiff in a pending state action has dismissed her claim with prejudice.

As of Sept 2006, more than 3,000 alleged Vioxx users have been dismissed before being scheduled for trial, including more than 1,100 dismissed with prejudice.

For more, go here.

Vioxx Trial Starts This Week (Hermans)

Today in Atlantic City, New Jersey Judge Higbee will hear the Hermans case. This Vioxx case involved Brian Hermans died in 2002 after taking Vioxx for 19 months. The lawyer representing Hermans is Mark Lanier, who as many know won the first Vioxx case that went to trial in Texas.

The Humeston case gets retried as well. Chris Seeger is the Plaintiff's attorney.

For more, go here.

Prempro: Trial #3 Starts Today

Today jury selection starts in an Arkansas Court on the third Prempro case to reach a jury. Helene Rush, of Little Rock, Arkansas is the Plaintiff. Wyeth is 1-1 in the first two cases which went to verdict.

Rush sued the company in 2005 after taking Prempro for nine years and developing breast cancer in 1999. There is a gag order in place in Rush's case.

In a pretrial filing in the Rush case, Wyeth attorneys pointed out that one episode of ABC's "Grey's Anatomy" featured a plot line that involved a man who was taking estrogen while undergoing a sex change. The male character in the show learned he had developed breast cancer and was told that continuing estrogen therapy in order to remain a woman came at the cost of dying of breast cancer.

A $100 Million Dollar Ad Campaign

No, not by an attorney. Who knew we all need defibrillators? They do have value, but take a get ready pill for the sheer volume of ads about to commence.

"Medical technology giant Medtronic Inc. will launch a $100 million marketing campaign today to raise awareness about the dangers of sudden cardiac arrest -- and the role of heart defibrillators in saving lives." Source here.

Aspirin: The All Purpose MVP?

Men who take a low dose of aspirin every other day may cut their risk of asthma, researchers said. Source here.

A new analysis of a key study from the 1980s that showed aspirin prevented almost half of first heart attacks found it has a similar, though less potent, impact on asthma. Aspirin users were 22 percent less likely to develop the lung condition in the Physician's Health study than those taking a placebo.

``The study suggests that people who are taking aspirin and don't have asthma, it may be preventing asthma,'' said Tobias Kurth, an assistant professor of medicine at Harvard Medical School.

I've been taking low dose aspirin for several years now. I also exercise regularly, and during the winter months have notices that symptoms suggesting exercise-induced asthma have not been as pronounced since taking aspirin. Either that or my running is much slower now. Maybe a little of both.

The All Pharma Cheerleading Squad

From edrugsearchcom, I stumbled across this ...

A while back the New York Times wrote a story about the decision by several pharmaceutical companies and others in the medical industry to hire reps who market drugs or medical services to physicians based not on medical knowledge — but purely (and cynically) on sex appeal. There have been legendary stories about doctors who may have believed a sales pitch to be an invitation for more. It's known that in several instances cheerleaders - literally - were hired to pitch drugs or medical services.

So, at eDrugSearch you can find information as well as pics of these ... reps. There are at least sixteen. "Carla" is here in my hometown:


Here bio is right here.

The eDrugSearch site also refers to the NYT article, and you can find that here.

For MLK, Jr. Day: A Book Worth Reading

My view of Dr. King and the civil rights movement was profoundly changed after reading Parting the Waters. It's more than just a biography of the Rev. Martin Luther King Jr.

Taylor Branch's thousand-page effort won the Pulitzer Prize as well as the National Book Critics Circle Award for General Nonfiction. As aptly noted in one review of the book, it "profiles the key players and events that helped shape the American social landscape following World War II but before the civil-rights movement of the 1960s reached its climax. The author then goes a step further, endeavoring to explain how the struggles evolved as they did by probing the influences of the main actors while discussing the manner in which events conspired to create fertile ground for change."

To have any substantial sense of the civil rights era, this book is a must read.

Vioxx: NJ State Court Judge Rules

Judge Carol Higbee cut down the number from four to two in Atlantic City, where opening arguments at the trial are set for January 22, 2007. Merck has been seeking to try each case individually rather than in a group.

Jurors at the next trial will hear the case that was already tried, Frederick Humeston. He survived a heart attack in 2001 after taking 56 Vioxx pills.

Attorney Mark Lanier will try the next Plaintiff's case for Kathleen Hermans Messerschmidt, whose brother, Brian Hermans, died of a heart attack in 2002 after taking Vioxx for almost seven months.

For more, go here.

Spell Check

I'm one who on this blog from time to time may not catch a word correctly spelled, but this snapshot taken from a news broadcast shows how important it is to make sure that what you send out for public consumption is correct.

The shot is from a news broadcast in Birmingham, Alabama.

Duration Calculation Results

I'm on the road a lot, and invariably while away from the office a FAX or email requesting action by a date certain will be received.

While most computer programs take care of date calculation, a handy site on the web may be found at timeanddate.com

Go here for the page within that site that allows you to calculate duration.

End of Premarin (HRT) Usage = Horse Slaughter

With few rdoctors prescribing Premarin or Prempro, Wyeth Pharmaceuticals, has shut down most of its horse ranches where 17,500 mares and their foals that are no longer needed for the production of the hormone used in the drug. The veil has been lifted on how Wyeth made the drugs.

In the past a ranch would be set up and pregnant mares' urine, or PMU, would be kept continually pregnant and tethered to a collection cup so that her estrogen-rich urine could be used to make the drug prescribed to treat menopause symptoms.

The mare's foals — bred in the field with little medical attention — are often sold by the pound and slaughtered for their meat.

For more go here. You can learn how to adopt a horse being discarded, go here and here.

Lilly to Settle More Zyprexa Lawsuits

Eli Lilly and Co. said Thursday it will settle about 18,000 additional lawsuits alleging the drugmaker did not adequately warn patients that its anti-psychotic medication Zyprexa carries a heightened risk of diabetes.

For more, go here.

College Football: Gators Win National Championship

Light posting until now, as I had a chance to see my school's football team win a National Championship.


More later.

Parkinson's drugs linked to heart damage

Patients taking the drugs pergolide, developed by Eli Lilly and sold under the brand name Permax, and cabergoline, developed by Pfizer and sold under the brand Dostinex, had a sharply higher risk of heart valve damage than those taking other therapies, according to a recently released set of studies.

The studies, included one that analyzed stats of 11,417 patients in Britain and one of which tested 245 patients in Italy, reinforce the results of smaller studies showing drugs that activate a cellular receptor known as 5-HT2b can cause damage to the heart valve, a serious condition that can lead to heart failure and sudden death.

The British study showed patients taking pergolide were 7.1 times more likely to develop heart valve damage than those who took other treatments. Patients taking the highest doses of the drug had a 37 times greater risk.

For more, go all over the web here.

2007: What's On Your List?

I wrote about resolutions at the end of 2006. I appreciate that many do not commit to making any, but I do. A few on my list, in addition to the the ones posted earlier:

Use Speak Write, a dictation system found on the web at the link. I have already used it this year - sign up for an account, and you use your phone to dictate. It arrives in your email box as an attachment, and only costs 1.5 cents per word. I tend to dictate a bit rapidly, and in 2006 staffers would complain quite a bit. Yesterday's first try with Speak Write was nearly perfect, it arrived in about twenty minutes, and there were no staff complaints.

Wireless card for my laptop - seems like a no brainer, but until yesterday I never committed. Now I wonder how I lived without it. While my office is in Atlanta, I drive to meet clients in the hinterlands where terms like WiFi and coffeehouses with the net do not exist as of yet (Ever been to Douglas, GA?).

There are several more I will be posting about as the day and week moves on. Will you share your resolutions? I'm happy to post them here. You can email me at zamoralawoffices@yahoo.com