Saturday, December 23, 2006
Point of Law notes that Eli Lilly has responded to the New York Times articles discussing Zyprexa misconduct. Here are links to Eli Lilly's response to the 12/17 NYT article, Eli Lilly's response to the 12/18 NYT article, and Eli Lilly's response to the 12/21 NYT article.
Article in the L.A. Times -- NIH researcher is ordered to forfeit Pfizer payments, by David Willman:
A federal judge on Friday spared a convicted National Institutes of Health researcher, Dr. P. Trey Sunderland III, any prison time but ordered him to hand over $300,000 in illicit payments he took from a major drug company.
U.S. District Judge J. Frederic Motz also sentenced Sunderland to two years of supervised probation and 400 hours of community service.
"Obviously, this was unacceptable conduct," Motz said.
Sunderland had pleaded guilty Dec. 8 to a criminal conflict of interest related to his payments from Pfizer Inc. The sentence matched a plea agreement in November between prosecutors and Sunderland's lawyers.
Sunderland took Pfizer's money from 1998 to 2003 while he collaborated with the company in his official federal role as a researcher of Alzheimer's disease.
Friday, December 22, 2006
Article in the Chicago Tribune -- Chrysler recalls vehicles to reprogram brake system computers, by the Associated Press:
DaimlerChrysler AG's Chrysler Group said Friday it was recalling more than 60,000 vehicles to reprogram a brake system computer to avoid the loss of antilock brakes and traction control.
The recall involves 62,369 model year 2007 Chrysler Sebring, Chrysler 300, Jeep Commander, Jeep Compass, Jeep Grand Cherokee, Jeep Liberty, Jeep Wrangler, Dodge Nitro, Dodge Magnum, Dodge Charger and Dodge Caliber vehicles.
The automaker said that in a small number of vehicles, the instrument panel warning lamps might illuminate and be followed by the loss of its Electronic Brake Distribution, antilock brake system, traction control and speedometer functions. That could lead to a loss of vehicle control.
Article in the Wall Street Journal -- Texas Jury's Vioxx Finding Stands, But Plaintiff Award Is Lowered, by Heather Won Tesoriero:
In a Vioxx case that has taken a number of unexpected twists and turns, a Texas state judge entered a judgment in favor of a plaintiff, although it reduced the $32 million award to $8.7 million under state law.
The judge rejected Merck & Co.'s request to reverse the jury's decision that Vioxx caused the plaintiff's heart attack.
In April, a Rio Grande City, Texas, jury awarded Felicia Garza and her sons $32 million after finding Merck liable for the death of Leonel Garza. In the months following the verdict, a woman not connected to the trial came forward and said that she had witnessed Mrs. Garza exchanging money with juror Jose Manuel Rios. In depositions, Mr. Rios said that he had borrowed thousands of dollars from Mrs. Garza over the years, but didn't have any outstanding debts at the time of the trial.
Merck conducted post-trial discovery in the matter and after reviewing bank and phone records, asserted that Mr. Rios borrowed $12,700 from Mrs. Garza and that there were more than a dozen calls between the Rios's phone and Mrs. Garza during the case.
Article in the New York Times -- Court Cuts Valdez Judgment Against Exxon, by the Associated Press:
A federal appeals court on Friday cut in half a $5 billion jury award for punitive damages against Exxon Mobil Corp. in the 1989 Valdez oil spill that smeared black goo across roughly 1,500 miles of Alaskan coastline.
The case, one of the nation's longest-running, non-criminal legal disputes, stems from a 1994 decision by an Anchorage jury to award the punitive damages to 34,000 fishermen and other Alaskans. Their property and livelihoods were harmed when the Valdez oil tanker struck a charted reef, spilled 11 million gallons of crude oil.
It's the third time the 9th U.S. Circuit Court of Appeals court ordered the Anchorage court to reduce the $5 billion award, the nation's largest at the time, saying it was unconstitutionally excessive considering U.S. Supreme Court precedent.
This time, in its 2-1 decision, the court ordered a specific amount in damages, while its previous rulings demanded a lower court to come up with its own figures.
Op-ed in the L.A. Times -- The myth of the big bad drug companies, by Professor Richard Epstein of University of Chicago Law School:
THE PHARMACEUTICAL industry is getting bad press. Recent books by Marcia Angell, the former editor of the New England Journal of Medicine, and Jerome Kassirer, another former editor of the journal, have harshly condemned the industry for recklessness, insensitivity and all-consuming greed. They gain sales by spicing up their titles with inflammatory phrases about "deception," "complicity" and how drug companies "endanger your health."
I take a different approach. I don't defend every business decision made by the great pharmaceutical research houses. To the contrary, much recent commentary suggests that many such companies have committed themselves to a blockbuster-drug model — in which a company's success or failure depends on a few vital, high-selling drugs — that may prove unsustainable over the long haul. If so, I believe that those firms should suffer the financial consequences of their mistaken business choices. Government bailouts are no more appropriate for Merck and Pfizer than they are for Chrysler or Ford.
Nonetheless, critics like Angell and Kassirer are absolutely wrong to portray the nation's big drug companies as heartless, avaricious behemoths that act in whatever manner they choose and always get their way. The truth is, the pharmaceutical industry is too heavily regulated. Its big problem today is not that it's free to run roughshod over the needs of consumers, but that it operates in a hostile and excessive regulatory environment that frustrates sound business decision-making and keeps down pharmaceutical company share prices in the stock market.
Professor Epstein has also recently written a book on the same topic -- Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (Yale Univ. Press 2006). Here's the book description from the publisher:
This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry.
While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.
Thursday, December 21, 2006
Another investigative article in the New York Times about Eli Lilly's conduct with Zyprexa -- Disparity Emerges in Lilly Data on Schizophrenia Drug, by Alex Berenson:
For at least a year, Eli Lilly provided information to doctors about the blood-sugar risks of its drug Zyprexa that did not match data that the company circulated internally when it first reviewed its clinical trial results, according to company documents.
The original results showed that patients on Zyprexa, Lilly’s pill for schizophrenia, were 3.5 times as likely to experience high blood sugar levels as those taking a placebo, according to a February 2000 memo sent to top Lilly scientists. The memo is one of hundreds of internal Lilly documents provided to The New York Times by a lawyer in Alaska who represents mentally ill patients.
But the results that Lilly eventually provided to doctors until at least late 2001 were very different. Those results indicated that patients taking Zyprexa were only slightly more likely to suffer high blood sugar as those taking a placebo, or an inactive pill.
Another Lilly report, from November 1999, shows that Lilly found after examining 70 clinical trials that 16 percent of patients taking Zyprexa for a year gained more than 66 pounds.
The company did not publicly disclose that figure, instead focusing on data from a smaller group of clinical trials that showed about 30 percent of patients gained 22 pounds.
Article in the New York Times -- Addictions: Smoking Again After Lung Cancer Surgery, by Eric Nagourney:
What does it take to get smokers to give up the habit? For some, not even lung cancer surgery does the trick.
In a study of lung cancer patients, researchers found that almost half started smoking again within a year after surgery -- most within two months of the operation.
It's interesting that the Times assumed the decision to keep smoking stemmed from addiction, even though the article didn't report any discussion of addiction by the underlying study. Although clearly lung cancer would challenge anyone's decision to keep smoking, it's not impossible that someone would choose to continue smoking out of enjoyment. Moreover, while the article notes that smoking after lung cancer increases one's health risks, the article does not discuss the background rate of survival from lung cancer without smoking. If the survival rates from lung cancer are still extremely low even with quitting smoking, it's conceivable one might decide to keep smoking to enjoy the remainder of his or her life.
Article in the New York Times -- Vioxx Award Cut to $7.75M, by the Associated Press:
A judge in a Texas widow's lawsuit over the Merck & Co. drug Vioxx on Thursday reduced a $32 million jury award to about $7.75 million so that it conformed to state law.
A state jury in April found Merck & Co. liable for the death in 2001 of Leonel Garza, a 71-year-old man who had a fatal heart attack within a month of taking the since-withdrawn painkiller.
After the verdict was issued, the company was ordered to pay the Garza family $7 million in noneconomic compensatory damages and $25 million in punitive damages.
But Judge Alex Gabert, in a Rio Grande City courtroom, ordered the punitive damage reduced to conform to a 2003 Texas law that caps punitive damages at twice the amount of economic damages -- lost pay -- and up to $750,000 on top of noneconomic damages.
Because Garza was retired, the jury awarded no economic damages, so Merck was ordered to pay the most the family could receive under state law.
In this case, the defense is also seeking a new trial based on upon financial contact between the widow plaintiff and one juror:
Merck attorneys in September were granted access to bank and cell phone records they said would show an improper financial relationship between juror Jose Manuel Rios and Felicia Garza, the widow.
Rios, who earns $22,000 a year as a school janitor, testified in a post-trial deposition to borrowing up to $10,000 interest-free from Felicia Garza. He said the loans included $2,500 that was paid off just weeks before jury selection in the case.
Article in the New York Times -- NRC: Nuclear Workers Fear Retribution, by the Associated Press:
Some workers at a nuclear power plant complex just north of New York City are reluctant to raise safety concerns because they fear retribution, the Nuclear Regulatory Commission said Thursday.
During an inspection of the Indian Point complex in September, ''We found out that there were workers who perceived that they would be treated negatively by management for raising issues and consequently some of the workers expressed reluctance to raise issues under certain circumstances,'' said NRC spokesman Neil Sheehan.
Article in the New York Times -- Vegas Judge OKs Part of Smoking Ban, by the Associated Press:
Smoking in Sin City bars might get you a ticket from now on, but it won't get you thrown in jail, a judge ruled Thursday.
Clark County District Judge Douglas Herndon said he would allow a voter-approved smoking ban to take effect immediately, but he barred police from enforcing it. Health inspectors, however, will be able to issue $100 tickets, he decided.
The ban covers some bars and the areas around slot machines at supermarkets, gas stations and convenience stores.
Tuesday, December 19, 2006
Editorial in the New York Times -- Playing Down the Risks of a Drug. Here's an excerpt:
It was bad enough when studies showed that the newest and most heavily promoted drugs for treating schizophrenia weren’t worth their high cost. Now the disturbing tale of their excessive use has taken a tawdry turn with revelations that Eli Lilly, a pharmaceutical giant, has consistently played down the risks of its best-selling antipsychotic drug, Zyprexa, and has promoted it for unapproved uses.
The details were spelled out in The Times this week by Alex Berenson, who drew on hundreds of internal Lilly documents that have surfaced in legal proceedings. Although Lilly says the documents present an inaccurate picture, they offer persuasive evidence that the company engaged in questionable behavior to prop up its best-selling drug, which creates almost 30 percent of Lilly’s revenue.
Article in the New York Times -- Money to Treat 9/11 Workers Will Run Out, Officials Say, by Sewell Chan:
The roughly $40 million that was set aside by the federal government to treat rescue workers, volunteers and firefighters who became ill after helping with the 9/11 cleanup and recovery will run out in months, physicians and federal officials said yesterday.
Members of Congress from New York and New Jersey secured $75 million a year ago to pay for health care expenses — including $40 million for treatments like drugs and medical procedures — for about 32,000 workers who reported ailments after working at ground zero. Distribution of the treatment money did not begin in earnest until October.
Officials at the two major monitoring and treatment programs, one run by Mount Sinai Medical Center and the other by the Fire Department, said yesterday that at the current spending rate, the treatment money would run out by spring or summer. They told top federal health officials that unless more financing was provided, they would be forced to notify thousands of patients that their treatment could soon end.
Monday, December 18, 2006
Article in the Wall Street Journal -- FDA Issues Warning For Cancer Treatment, by Heather Won Tesoriero:
Two patients taking a drug commonly used to treat cancer and rheumatoid arthritis died from a rare brain infection, the Food and Drug Administration and the drug's makers warned yesterday in an announcement that instructed doctors prescribing the drug to watch for signs of the problem.
The patients who died were receiving the drug, Rituxan, as a treatment for lupus. Rituxan, sold by Genentech Inc. and Biogen Idec, isn't approved for lupus, though doctors are allowed to prescribe medications as they see fit. The patients contracted viral brain infection known as progressive multifocal leukoencephalopathy (PML).
In a public safety alert, the FDA warned that PML may be a risk for patients taking Rituxan for any reason. And in a letter to health-care professionals, Genentech said that doctors prescribing Rituxan should be on alert, particularly in patients with lupus or certain cancers.
Another interesting, detailed, and troubling article in the New York Times about Eli Lilly and Zyprexa -- Drug Files Show Maker Promoted Unapproved Use, by Alex Berenson:
Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.
The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.