Saturday, May 26, 2007

Glaxo's Large Avandia Clinical Study In Question Because of Patients Dropping Out

Article in the New York Times -- Test of Drug for Diabetes in Jeopardy, by Stephanie Saul.  Here's an excerpt:

A large clinical study meant to test the heart safety of the diabetes treatment Avandia may be in jeopardy as a result of recent reports of the drug’s risks, according to an executive for its maker, GlaxoSmithKline.

Dr. Ronald L. Krall, the medical director for GlaxoSmithKline, said in a telephone interview yesterday that some of the 4,450 patients enrolled in the drug trial, called Record, have dropped out this week because of safety concerns about Avandia.

Dr. Krall said he did not yet know how many patients have withdrawn, but said Glaxo was now worried about whether it could complete the drug trial, which has been scheduled to run through next year. The company has been counting on a successful outcome from the study to dispel widespread concerns that Avandia carries a higher risk of heart attacks than other diabetes drugs.

Now, though, the independent research committees overseeing the study “are concerned about the ability of the study to continue” and are “considering what to do to prevent people from dropping out of the trial,” Dr. Krall said.

BGS

May 26, 2007 in Avandia, FDA | Permalink | Comments (0) | TrackBack (0)

Contact-Lens Solution Linked to Rare, Serious Eye Infection

Article in the Wall Street Journal -- Contact-Lens Solution Is Tied to Eye Infection, by Jon Kamp.  Here's an excerpt:

U.S. health investigators have linked a contact lens solution made by Advanced Medical Optics Inc. to the outbreak of a rare but serious eye infection that can cause blindness.

The news comes just a day after Advanced Medical Optics said it's interested in exploring an offer for rival Bausch & Lomb Inc., which was hurt from the world-wide recall of a lens solution last year amid links to a different infection. The Advanced Medical Optics product at issue is called Complete MoisturePlus, one of several all-in-one-bottle solutions on the market.

As of Thursday, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention has identified 138 "culture-confirmed" cases and has interviewed 46 patients.

Research shows 36 of those people wore soft contact lenses, 21 reported using the Advanced Medical Optics product a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC's division of parasitic diseases.

BGS

May 26, 2007 in Medical Devices - Misc. | Permalink | Comments (1) | TrackBack (0)

Friday, May 25, 2007

Glaxo Courts Doctor Support for Diabetes Drug Avandia

Article in the Wall Street Journal -- Glaxo Courts Doctor Support of Avandia: No Plans Currently Set To Run Consumer Ads To Defend Drug's Safety, by Jeanne Whalen and Anna Wilde Mathews.  Here's an excerpt:

GlaxoSmithKline PLC, under pressure to protect its diabetes drug Avandia, is reaching out to physicians to defend the drug's safety, but isn't currently planning a similar ad campaign for consumers.

In meetings with doctors, Glaxo sales representatives are focusing on data from a large clinical trial called A Diabetes Outcome Progression Trial, or ADOPT. "We are reassuring physicians about the safety data we have, particularly looking at ADOPT," said Alice Hunt, a Glaxo spokeswoman.

Monday, the New England Journal of Medicine released an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. Glaxo disagrees with the finding, which it says is contradicted by data the company considers stronger, including ADOPT data.

Congressional investigators are examining the Food and Drug Administration's and the company's handling of the drug. Yesterday, Republican Sen. Charles Grassley of Iowa said that the FDA's division of drug-risk evaluation had recommended a tough "black box" warning about heart-attack risk for the label of Avandia, which hasn't been added. He and Senate Finance Committee Chairman Max Baucus, a Montana Democrat, introduced a bill that would grant researchers access to Medicare data on medical treatments.

BGS

May 25, 2007 in Avandia, FDA | Permalink | Comments (0) | TrackBack (0)

Wednesday, May 23, 2007

Glaxo's Agreement to Disclose Publicly Clinical-Trial Results Lead to Finding of Avandia Risk

Article in the New York Times -- For Drug Makers, a Downside to Full Disclosure, by Barry Meier.  Here's an excerpt:

When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.

The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.

This week, GlaxoSmithKline learned what that greater disclosure could mean.

A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

“It was a treasure trove,” Dr. Nissen said about the Web site.

BGS

May 23, 2007 in Avandia | Permalink | Comments (0) | TrackBack (0)

Concerns About Glaxo Drug Avandia and PPAR Drugs

Article in the Wall Street Journal -- Avandia Concerns Reopen a Wider Debate, by Anna Wilde Mathews and Jeanne Whalen.  Here's an excerpt:

The assertion that GlaxoSmithKline PLC's widely used diabetes drug Avandia is tied to a risk of heart attacks will reopen debate over a potentially valuable, but problem-plagued, type of drugs.

Avandia and the competing diabetes medication Actos, made by Japan's Takeda Pharmaceutical Co., are known as PPAR drugs. They work by affecting receptors in a cell's nucleus that can affect a broad range of human genes. (PPAR represents the name of the receptors, which are called peroxisome proliferator-activated receptors.)

The upshot can be valuable treatment benefits for serious conditions such as diabetes but also an enormous range of sometimes unpredictable side effects that have sidelined many treatments before they reached the market. Among the companies still working on possible new PPAR drugs are Glaxo, AstraZeneca PLC and closely held Metabolex Inc., which has partnered with Johnson & Johnson.

"It is a challenging class of drugs," said Robert Meyer, who heads the Food and Drug Administration office that oversees diabetes medications. "These are drugs with many effects and many targets" in the body.

BGS

May 23, 2007 in Avandia, FDA | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 22, 2007

Bush Bars Federal Government from Using Lawyers on Contingency-Fee Basis

Article on May 17 in the Wall Street Journal -- U.S. Policy on Attorneys Fees Sparks Debate at State Level, by Amir Efrati.  Here's an excerpt:

President Bush yesterday signed an executive order barring the federal government from using lawyers on a contingency-fee basis, an arrangement where lawyers don't get paid until a matter is resolved and then claim a portion of any winnings.

Such arrangements rarely occur on the federal level, but the action quickly sparked debate about the practice on a state level, where it is more commonly used by state attorneys general and has become part of a wider debate on the civil legal system.

The order states that lawyers hired by the federal government should be "compensated in amounts that are reasonable, not contingent upon the outcome of litigation or other proceedings."

President Bush has long had an informal policy against contingency-fee arrangements with outside lawyers, said Jeff Rosen, general counsel of the White House's Office of Management and Budget. Now, that policy is "being institutionalized," he said.

The practice is part of a wider issue about civil litigation in the U.S. So-called tort reformers say the system is getting overwhelmed and imposes too many costs on society. Plaintiffs' lawyers argue that lawsuits are often the only way to give ordinary citizens a chance to protect their rights.

The Wall Street Journal Law Blog had a related post, Bush Bars Gov’t From Using Contingency-Fee Lawyers, by Peter Lattman.  Thanks to Richard Nagareda for pointing us to the WSJ Law Blog post.

Howard Erichson previously posted on this blog about the issues surrounding the government's use of outside counsel reimbursed by contingency fees.  And the Drug and Device Law Blog has a helpful post with many links to various other comments on Bush's executive order barring government use of contingency-fee lawyers.

If a particular law is written giving the government discretion in the prosecution of an action, then handing over control to outside counsel compensated by contingency fee is problematic.  Yet interestingly, we tolerate those problems in the regular tort suit where the plaintiff has discretion over settlement of the suit, and one would think that sophisticated government lawyers as "clients" would be better able to restrain outside counsel than unsophisticated tort claimants.  Indeed, corporate counsel sometimes retain outside law firms to represent the corporation on a contingency fee basis -- if we trust corporate counsel to supervise, can't we trust government lawyers to do the same?

My broader concern is that the government is being deprived of an efficient method of bringing talented lawyers to bear to further government representation.  The irony here is strong -- the Bush administration and Republicans generally are big fans of privatization of services because it brings best quality for lowest cost; but when the service at issue is lawsuit representation against corporate defendants, then it's a different matter.  I would keep to a more consistent line, and embrace the benefit of private markets across the board -- with all the disclosures and ethical rules necessary to prevent corruption in the award of government contracts.

BGS

May 22, 2007 in Procedure | Permalink | Comments (0) | TrackBack (0)

FDA Warns Novartis's Drug Exjade Could Cause Kidney Failure

Article in the Wall Street Journal -- FDA Warns Novartis's Exjade Could Cause Kidney Failure, by Jennifer Corbett Dooren.  Here's an excerpt:

The Food and Drug Administration warned health-care providers Tuesday about kidney failure and deaths possibly associated with Exjade, a Novartis AG drug that removes excess iron in patients undergoing regular blood transfusions.

In a May 14 letter to health-care professionals posted Tuesday to the FDA's Web site, Novartis said it received reports of kidney failure, some with a fatal outcome, in postmarketing reports of Exjade. The drug was approved in November 2005.

In a statement, Novartis said there were eight deaths associated with acute renal, or kidney, failure. More than 13,000 patients have been treated with Exjade since the drug was approved in November 2005.

Novartis said most of the patients had multiple illnesses and were in the advanced stages of their blood disorders. The company also said it received reports of patients developing a range of other blood disorders such as cytopenia, which is when the body stops producing or severely cuts back on making one or more type of blood cells, some of which led to additional patient deaths.

Although Novartis noted that patients already had preexisting blood disorders, the company said that "a contributory role for Exjade cannot be excluded."

BGS

May 22, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)

Prominent Doctor Publishes Study Showing Heart Risk from Glaxo Diabetes Drug Avandia

Article in the Wall Street Journal -- Sequel for Vioxx Critic: Attack on Diabetes Pill: Glaxo Shares Plunge As Dr. Nissen Sees Risk To Heart From Avandia, by Anna WIlde Mathews.  Here's an excerpt:

An analysis linking the widely used diabetes drug Avandia to higher risk of heart attacks represents a serious blow to GlaxoSmithKline PLC and underscores how outside critics have been empowered to challenge big-selling drugs after the outcry over the withdrawn painkiller Vioxx.

Glaxo rang up more than $3 billion in world-wide sales of Avandia last year. Its share price fell more than 7% after the New England Journal of Medicine released the analysis by prominent cardiologist Steven Nissen of the Cleveland Clinic, who helped raise early safety concerns about Vioxx. The analysis suggested that people on Avandia have a 43% higher chance of suffering a heart attack.

Glaxo said it "strongly disagrees" with his conclusions, which come from a "meta-analysis" in which results from many trials are combined. Glaxo said data sources it considers more reliable suggest that Avandia is no riskier for the heart than other diabetes medications.

Here's a link to the related article in the New England Journal of Medicine -- Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes, by Steven E. Nissen, M.D., and Kathy Wolski, M.P.H.; and a link to the related New England Journal of Medicine editorial --
Rosiglitazone and Cardiovascular Risk, by Bruce M. Psaty, M.D., Ph.D., and Curt D. Furberg, M.D., Ph.D.   

BGS

May 22, 2007 in Avandia, FDA | Permalink | Comments (0) | TrackBack (0)

Monday, May 21, 2007

WSJ Editorial On Shell Gasoline Class Action, and Some Ruminations in Response

Editorial in the Wall Street Journal -- A Tort Riot.  Here's an excerpt:

The depredations of the trial bar are legion. But sometimes a case is so exquisite in revealing the character of the modern tort industry that its details deserve national distribution. Such is the case of the 79 lawyers fighting like a hyena pack over the spoils of a $10 million Shell Oil settlement in New Orleans.

Back in 2004, Shell sold misformulated gasoline to tens of thousands of customers, fouling their fuel gauges and creating a class-action bonanza for four-score plaintiffs lawyers. Our readers won't be surprised to learn that most of the $10 million that Shell coughed up went to the lawyers. The plaintiffs got "a new fuel gauge and a 100 bucks," says Dane Ciolino, a law professor at Loyola University in New Orleans who's now involved in the case.

The lawyers, on the other hand got -- well, no one really knows exactly what they got, except for the judge and the handful of lawyers who divvied up the pot. The total amount that Shell agreed to pay the lawyers was about $6.9 million, but the rest of the details are under seal. The 79 lawyers who shared in that windfall are barred from discussing their take with anyone, according to a January gag order.

While the editorial does a fine job of pointing to problems with regard to division of the plaintiffs' counsel fees, I would disagree with one point: the Wall Street Journal suggests that all 79 lawyers "really didn't do anything for the common benefit."  By the Journal's own account, Shell's "misformulated" fuel "foul[ed] ... fuel gauges."  The new fuel gauges that were part of the settlement therefore seem important compensation.  Moreover, Shell was was deterred from future misconduct because it had to pay $10 million for misformulating its fuel and bothering consumers with broken fuel gauges. 

At base, however, the Journal as well as much of the public misunderstand the notion of the small-claims/negative-value class action.  When defendants harm many people in small amounts -- say a few dollars a piece -- traditional one-on-one litigation is not workable because the cost of each lawsuit exceeds the possible recovery.  No plaintiff's lawyer would accept such a small case on a contingency fee because the plaintiff's lawyer would spend more money trying the suit than the lawyer could recover -- hence the suit would produce "negative value."  Class actions offer one solution to this problem: by aggregating many individuals' claims together in one single proceeding, the total value at stake justifies the cost of bringing suit.  The small-claims class action thus provides one route to satisfying tort goals of deterrence, corrective justice, and compensation that would be abandoned if defendants who harmed in small amounts could simply continue on without fear of any lawsuits.

In such small-claims class actions, the attorneys fees are always going to loom large --  "You mean my lawyers got $3 million, when I got $3!"  But if lawyers didn't get paid, no one would have brought the lawsuit, no class member would have received anything, and liable defendants would have harmed without class members without any penalty.  Is that better?  While there may be many troubling aspects of class actions, the notion that plaintiffs' counsel fees greatly exceed each individual class member's recovery in a small-claims class action, or even the entire recovery of the class, is not a problem, as long as the fees themselves are reasonable given plaintiff's counsel's work (which is what court scrutiny of fees is intended to ensure).

Of course, it remains bothersome that there is no real market for class members' claims.  Ideally, each client should agree to the fees being charged by the lawyers.  Class members face three problems  First, notice of the class action and opt-out rights likely doesn't reach many class members.  Second, even those class members who receive notice may not understand it or meaningfully pay attention -- yet they will be included in the class if they fail to act affirmatively to opt out.  And third, those class members who pay attention to a class notice will likely only see a provision that a court will approve counsel fees when it's all over.  How can class members evaluate the benefit of the service against its cost, when they are not given clear information about how much it will cost? 

These ruminations lead to some tentative reform proposals to jumpstart a market in small-claims class actions.  First, provide more detailed information about fees to putative class members -- such as hourly rates (including any multiplier) or percentage of the fund.  Second, require that class members affirmatively show their agreement to the bargain by having them opt-in to the class.  One could foresee multiple plaintiffs' counsel competing against each other on price, and class members evaluating price against the perceived competence and experience of a particular law firm.  There's a free-market solution the Wall Street Journal should support.

BGS

May 21, 2007 in Class Actions, Ethics, Mass Tort Scholarship, Settlement | Permalink | Comments (0) | TrackBack (0)

Insurers Win Asbestos Ruling Against "Prepackaged" Bankruptcy

Article in the Wall Street Journal -- Insurers Win Asbestos Ruling, by Nathan Koppel.  Here's an excerpt:

Insurers scored a win Friday when a New Jersey court held they didn't have to pay asbestos-related claims that had been negotiated as part of a "prepackaged" bankruptcy.

The case, concerning the 2003 bankruptcy of Congoleum Corp., has been followed closely by combatants in the asbestos-litigation arena. Some companies that have faced asbestos liability have tried to control their exposure by filing prepackaged bankruptcies, which are negotiated ahead of a filing, potentially allowing a company to reorganize in an expedited fashion. Critics have argued that asbestos "prepacks" let plaintiffs' lawyers collect damages for dubious asbestos claims at the expense of insurers.

Congoleum is a manufacturer of flooring products. Asbestos-related injury suits against the Mercerville, N.J., company prompted it to file a prepackaged bankruptcy plan under which it agreed to pay more than $200 million in asbestos claims, Friday's ruling said.

Here's the decision: Download congoleum_asbestos_decision.pdf .  The WSJ Law Blog has a related post, Win for Asbestos Insurers, by Nathan Koppel.  Here's a link to the related post from Point of Law.

BGS

May 21, 2007 in Asbestos | Permalink | Comments (0) | TrackBack (1)