Monday, February 28, 2005

Did FDA Cox 2 Panel have 10 Industry ringers on it?

Ten of the 32 U.S. advisers who supported future sales of pain relievers Celebrex, Bextra and Vioxx have consulted in recent years for the drug makers, according to a consumer group analysis of medical journals and other records.

Ten panelists were paid consultants for Pfizer or Merck, according to the consumer group Center for Science in the Public Interest (CSPI).

If those 10 panelists had not voted, the committee would have rejected future sales of Bextra and Vioxx. The Celebrex vote would not have changed because all but one member supported keeping that drug on the market.

The analysis sparked more congressional concerns over the FDA and its policing of drug safety.

"Tthe votes ... are now, justly or unjustly, tainted," said Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee.

The CSPI analysis, first reported by the New York Times, cited references from financial disclosures in medical journals and in public databases such as

Each of the 10 advisers with industry ties voted to keep Bextra on the market. Nine of them voted to let Vioxx be sold again. Merck withdrew Vioxx last September after a study linked the pain reliever to heart attacks and strokes.

If those 10 members had not cast their votes, the committee would have voted 13-7 to recommend that Bextra be withdrawn and 14-8 that Vioxx should not return to the market.

Comment: Is it any surprise in the least that the panel had 10 "professionals" who were paid by Merck for writing about it's products? Thank goodness a Republican was outraged about it.

Friday, February 25, 2005

Non Party Form Interrogatories (Georgia)

Recently the Georgia Assembly passed what is referred to as SB3 - Tort Reform.

Within the statute, a defendant may now assert that some other "party" should be held responsible for the

injuries to your client. The statute provides at 51-12-33, (a) through (c):

In assessing percentages of fault, the trier of fact shall consider the fault of all persons or entities who contributed to the alleged injury or damages, regardless of whether the person or entity was, or could have been, named as a party to the suit.

(d)(1) Negligence or fault of a nonparty shall be considered if the plaintiff entered into a settlement agreement with the nonparty or if a defending party gives notice not later than 120 days prior to the date of trial that a nonparty was wholly or partially at fault.

In Florida, attorneys have lived with a similar statute for years. In what is referred to as
Mesmer Interrogatories, Plaintiffs' lawyers flesh out the so called "non -parties" that the Defendants may seek to inject into the case, and ultimately add to the verdict form.

Florida does not have a duty to supplement Interrogatories. You might want to mail this same set more than once. I can almost guarantee that you will get something like "discovery is ongoing, unable to identify said parties at this time."

By the time discovery closes, I would then move for Summary Judgment and seek fees, stating that there are in fact no such parties.

I use the ones listed below - feel free to use as well:

1. Do you contend any person or entity other than you is, or may be liable in whole or part for the claims asserted against you in this lawsuit? If so, what is the name and address of each person or entity; the legal basis for your contention and the facts or evidence upon which your contention is based and have you notified each person or entity of your contention?

2. If your answer to Interrogatory number 1 is "yes", please state the name(s) of such individuals or entities.

3. If your answer to Interrogatory number 1 is "yes", please state all facts upon which you rely to support your contention that those named in answer to Interrogatory number 2 were at fault.

4. If your answer to Interrogatory number 1 is "yes", please state the names and addresses of all witnesses with knowledge or opinions, or both, to support your contention that those named in answer to Interrogatory number 2 were at fault in causing Plaintiff's injuries and damages.

5. If your answer to Interrogatory number 1 is "yes", please state the percentage of fault you attribute to those named in answer to Interrogatory number 2 and the factual basis for such apportionment.

6. In your Affirmative Defense contained in paragraph , you state that:[add language here]

(a) Please state the factual basis upon which you asserted this affirmative defense.

(b) Please give the names and addresses of any witnesses you are aware of who can substantiate said facts.

(c) If there is any documentation to support that affirmative defense presently in your custody or that of your agents and/or employees, please give the name and address of the person who has custody of the document.

Case law from Florida should be posted in the next few days, but here is a sample:

"If a defendant wants a Mesmer defendant on the verdict form, the defendant must see to it that there is legally sufficient evidence in the record from which the jury can find that the Mesmer defendant was at fault. If there is no such evidence, the defendant is not entitled to have the Mesmer defendant placed on the verdict form . . . Again if the Mesmer defendant is exonerated because there is no evidence of fault, that defendant does not go on the verdict form."

Wednesday, February 23, 2005

England gets it: Misleading ads will be "shamed"

Britain's medicines regulator is planning a crackdown on misleading drug advertising and will "name and shame" offending companies.

The Medicines and Healthcare products Regulatory Agency (MHRA) will also in future vet the entire advertising portfolio of firms which regularly breach the guidelines.

"It is vital that we tackle this type of poor practice swiftly and effectively," he said.

Britain does not allow advertising of prescription medicines direct to consumers, as happens in the United States, but patients are increasingly exposed to adverts because the government is allowing more products to be sold over the counter.

"It is vital that we tackle this type of poor practice swiftly and effectively," he said.

Britain does not allow advertising of prescription medicines direct to consumers, as happens in the United States, but patients are increasingly exposed to adverts because the government is allowing more products to be sold over the counter.

Advertising of medicines -- a boom business in recent years -- has become mired in controversy on both sides of the Atlantic recently, particularly in the light of the withdrawal of Merck's Vioxx pill last year.

COX 2 warnings in the EU:

The European Medicines Agency said last week it would require stronger warnings about the cardiovascular risks posed by a class of arthritis painkillers known as Cox-2 inhibitors.

It stopped short of calling for drugs, which are also being scrutinized by the U.S. Food and Drug Administration, to be taken off the market.

After a meeting in London, the agency's scientific experts said the Cox-2 medicines, used to alleviate the symptoms of rheumatoid arthritis, carry an increased risk of cardiovascular adverse events.

The agency issued a new warning that those who had suffered heart disease or strokes should not take any Cox-2 drugs, and those with uncontrolled high blood pressure should not take the medication etoricoxib, which is sold under the trade name Arcoxia by Merck & Co.

It urged doctors to use care when prescribing Cox-2 painkillers to patients who have risk factors for heart disease, including high blood pressure, high cholesterol, diabetes and smoking.

The agency also said that given the risks, doctors should prescribe the lowest effective dose for the shortest possible time for all patients.

The European agency last reviewed Cox-2 drugs in 2003.

Is Mobic next ?

A pain reliever called Mobic has shown a higher risk of heart attacks in early data than found with Merck & Co. Inc.'s now-withdrawn Vioxx, a veteran U.S. Food and Drug Administration scientist told an FDA advisory panel on Thursday.

The drug, made by privately-held Boehringer Ingelheim Pharmaceuticals, showed the effect in a new, yet-to-be published study, said David Graham, associate director for science and medicine at the FDA's Office of Drug Safety.

Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx, and any possible heart attack risk is important as more patients take the drug, Graham said.

The statistical risk of heart attack was 1.37 for Mobic, compared to 1.32 with Vioxx and 1.09 with Celebrex.

Germany-based Boehringer argued against Graham's claims. "We've taken a look at our post-marketing data and see nothing to indicate excessive cardiovascular risk," the company spokesman said.

Mobic is classified as a Cox-2 in some countries but is not considered part of that group in the United States, where is its only classified as part of the larger NSAID class, a Boehringer spokesman said.

Aspirin, naproxen and other NSAIDs can cause ulcers and dangerous bleeding.

Abbott Laboratories (ABT.N: Quote, Profile, Research) , which co-markets Mobic in the United States, said last month it expected U.S. sales of the drug to hit $1 billion in 2005.

Shares of Abbott closed off 27 cents to $46.56 on the New York Stock Exchange.

JP Morgan analyst Mike Weinstein said this was the first time any heart risk for Mobic has been noted.

"The topic will likely now warrant some extra monitoring," he said in a research note.

The FDA approved Mobic in 2000 to treat osteoarthritis, and in 2004 for rheumatoid arthritis. (Additional reporting by Debra Sherman in Chicago)

Germany to issue COX-2 guidelines

Germany will issue guidelines in the next few days to significantly restrict the use of so-called COX-2 inhibitors to ease pain, the country's drug regulator said on Monday.

Patients who either have had a heart attack or stroke, suffer from circulatory disorders of the heart or are at a high risk of developing such conditions should no longer use the medications, the regulator said in a statement.

The German regulator said patients with high blood pressure that can not be stabilised also should not use etoricoxib, another name for Merck & Co's Arcoxia.

The German regulator said that COX-2 inhibitors-- the general category to which Arcoxia, Vioxx, Celebrex and Bextra belong -- should be taken only in the smallest possible effective dose and only as long as absolutely needed.

It said that a risk evaluation process in the European Union for the class of COX-2 inhibitors was continuing and that a report was expected in April.

News from the FDA

From various sources, including wire sources:

The big question: Will Friday's news change the legal climate surrounding these drugs, especially Merck's Vioxx? There's still a long medical, legal and political path between the advisory committees' votes last week -- endorsing Vioxx and Pfizer's Celebrex and Bextra -- and the Food and Drug Administration's final decision.

The agency doesn't always follow the recommendations of its advisory panels, and the close votes on Vioxx (17-15) and Bextra (17-13 with two abstentions) certainly raise questions among investors as well as doctors and patients. Celebrex was supported by a 31-1 vote.

"We believe the key benefit to Merck is not necessarily generating incremental sales but potentially limiting legal liability," said David R. Risinger of Merrill Lynch, in a report to clients. Merck voluntarily withdrew Vioxx from the market on Sept. 30, saying that research showed a higher cardiovascular risk among patients taking the drug for more than 18 months vs. patients receiving a placebo.