And so another busy day winds down. We hope yours was as productive as ours. After all, something is always happening. We even had time to catch lunch with a couple of industry types (and, yes, we paid for ourselves). And now, on to the evening and some bedtime reading with one of the short people. Catch you in the morning…

Hundreds of Florida residents who claim Vioxx caused their strokes or heart attacks were squeezed out the $4.85 billion settlement and have filed a motion to be included, the Associated Press reports. If the motion is successful, people in a half-dozen other states - which, like Florida, give residents more than three years to file personal injury lawsuits - might also be added to the deal. But a Merck lawyer and a plaintiffs’ lawyers say Florida residents waited too long to file suit or to get Merck to extend the deadline. “That train has left the station,” says Russ Herman, the plaintifff’s lawyer.

The FDA warned Novartis that a plant in Marburg, Germany made contaminated vaccines, and the drugmaker failed to find the source of the problems. The agency found significant deviations from good manufacturing practices at the plant, which makes a rabies vaccine, and diphtheria and tetanus concentrates, according to a Jan. 24 letter posted on the FDA web site. The FDA letter cited multiple cases of contamination and non-sterility, and failure to test and determine the origins of the problems.

Lilly reported fourth-quarter profit rose more than sixfold on sales of the Cymbalta antidepressant and the Cialis erectile dysfunction med. Net income rose was $854.4 million, or 78 cents a share, up from $132.3 million, or 12 cents, after adjustments. Revenue rose 22 percent to $5.19 billion, fueled by a 48 percent increase in sales of Cymbalta, Lilly’s fastest-growing medicine. Sid Taurel, the ceo, expects sales of Cymbalta to surpass those of the top-selling Zyprexa antipsychotic this year, Bloomberg News writes.

The war between the big drugmaker and Teva Pharmaceuticals just took an interesting turn. Wyeth has launched its own generic version of the heartburn med, five weeks after Teva’s surprise decision to sell a copycat before a nasty patent lawsuit had played out. The move comes two days before the expiration of an extended standstill agreement, which meant the Israeli generic maker agreed not to make additional shipments.

You may recall that, last September, a federal Judge in New Jersey denied a motion by Wyeth and its partner, Altana Pharma, to halt sales of Teva’s generic version, which the FDA approved the previous month. While Teva is not disputing it infringed the patent, the company argued the patent itself is not valid. Wyeth, which still expects a trial to begin in the second half of this year, already filed an appeal over the denied injunction.

“Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients,” Bernie Poussot, Wyeth’s ceo, says in a statement. “We believe the Protonix compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva.”

The Protonix patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007. Meanwhile, Wyeth is examining every aspect of its business to cut costs to offset the impact of a generic launch of Protonix, along with the delay of new drug approvals. The drugmaker recently disclosed plans to cut up to 10 percent of its workforce.

John Lechleiter will soon succeed Sid Taurel at the helm of the big drugmaker. A scientist by training, Lechleiter is wasting little time setting a tone. Although he doesn’t take credit for firing back at The New York Times last week, he clearly revels in the openness he believes was achieved by refuting a story about failing to disclose Prozac clinical trials, which was later corrected.

Today, Lechleiter tells The WSJ Health blog that Lilly and pharma get a bad rap, and so he’s fighting back. “We can talk and talk and talk but we’ve got to walk the talk,” Lechleiter says. “We’ve been forthright. When we’re willing to come back and set the record straight, we’re showing through actions that this is not the stereotype people have of this industry….we’re not hiding secrets in the closet.”

If so, John, then why not release all Zyprexa data that was the subject of so much controversy last year in federal court, where some documents about hidden or undisclosed side effects were leaked but remain under seal? And why wasn’t there a press release issued last week when another 900 Zyprexa personal-injury claims were settled for an undisclosed amount? The deal, by the way, meant Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled.

He also refers to the trumpeted policy of registering all clinical trials for marketed products since December 2004. But Phase IV trials completed before July 1, 2004 aren’t posted. Why that date? That’s when Lilly implemented its policy, after which the drugmaker “discloses publicly all medical research results that are significant to patients, health care providers or payers - whether favorable or unfavorable to a Lilly product.”

But Phase IV trials are conducted to look at side effects and safety; long-term risks and benefits, and how well the drug works when used in a real-world population beyond a clinical setting (and let’s not forget marketing claims). In other words, new info and fresh insights can be learned. For reasons that aren’t clear, Lilly has chosen to use a specific cut-off date and, as a result, patients, health care providers and payers are denied an opportunity to know as much as possible about its meds.

John, if Lilly isn’t hiding anything, perhaps when you officially become ceo, you’ll start releasing more info that your customers want to see.

Hat tip to the WSJ Health blog

According to a Jan. 3 letter the Johnson & Johnson unit wrote to the New Hampshire attorney general, an undetermined number of computers have gone missing and may be stolen from its Horsham, Pa., headquarters. And one or two contained sensitive personal info belonging to an unspecified number of speakers and consultants who were retained for a ‘National Faculty and Rounds on the Road’ program. (Here’s the letter).

Centocor says it was notified of the problem by its IT vendor in early October, 2007, and was provided additional details on Nov. 29th, 2007, although the drugmaker didn’t notify the New Hampshire AG until this month. The letter was written by Michael Schoeck, director of health care compliance at Johnson & Johnson, who also identifies himself as Centocor’s privacy director.

“Based on the subsequent investigation conducted by Centocor, one of the missing computers likely contained a file which included the name, city/state and social security/tax identification numbers of a number of people engaged by Centocor, including one resident of New Hampshire. We have made arrangements to provide 1 year of credit-monitoring services to each of the affected individuals at no cost to them,” the letter states.

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At its hearing this morning, the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations voted unanimously to approve a motion to subpoena FDA officials and investigators over clinical trial data for the Sanofi-Aventis antibiotic, which has been linked to liver failure.

The committee has been looking into whether Sanofi withheld info about Ketek risks, and whether FDA officials disregarded concerns raised by lower-ranking scientists when Ketek approved in 2004. The committee also wants the FDA to fork over FDA commish Andy von Eschenbach’s briefing book to determine whether he misled the committee during testimony last March. David Ross, a former FDA reviewer who worked on Ketek, last year said Andy’s testimony contained inaccuracies.

Committee staffers are frustrated that the FDA redacted an investigative memo from the FDA Office of Criminal Investigations before showing it to the committee. Congressional aides were told the documents summarize the FDA’s investigation of whether Sanofi-Aventis was aware of problems with a safety study before it was submitted to an FDA panel. Subpoenas will be issued to two FDA investigators, another to a former agency investigator, and one to a private individual who once worked for a contractor overseeing a study of Ketek, according to this memo the committee sent to the FDA.

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When several AIDS patients died after a clinical trial at a Beijing hospital five years ago, Viral Generics, a California biotech, was criticized for failing to explain adequately to patients they were taking part in a study rather than receiving a proven drug. There were also questions why some patients were given the experimental compound and others a placebo, The Financial Times writes.

The trial complied with current international standards and a Chinese investigation concluded that there was “no serious violation of ethical principles.” Even so, the paper cites this as an illustration of both the rapid growth in clinical trials in the developing world and what it calls the tensions caused by this latest form of globalization. Irene Schipper from Somo, a Dutch research group, tells the Times that existing guidance from the International Commission on Harmonisation – which governs best clinical practice among regulators in the US, Europe and Japan – “leaves all the options open and gives research efficiency priority over ethical considerations.”

Meanwhile, overseas trials continue unabated. Clinicaltrials.gov shows nearly 50,000 trials under way, and 10 per cent are outside North America, western Europe and Japan. The proportion of principal investigators registered with the FDA, but based outside the US and western Europe, rose from 5 per cent in 1997 to 29 per cent last year, the Times writes. The fastest growth in the past five years has come from India, China, Russia and Argentina. “We’re doubling in size every year and expect to keep doing so in each of the next few years,” Mark Engel of Excel PharmaStudies, a clinical research organization that runs trials in China for big pharma, tells the paper.

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In May 2006, David Peng, a dermatology professor at the University of Southern California, was disturbed by claims made by an Amgen district manager, who was trying to boost Enbrel at the expense of an older psoriasis med, methotrexate. And so Peng banned Amgen reps from doing ‘lunch-in-learns’ with residents at his clinic at USC’s Keck School of Medicine, and decided to use a med by Genentech for an investigator-initiated study.

We know this after reading an e-mail from an Amgen rep, Matt Mitchell, who was at the May 2006 sales call. He wrote this follow-up note to his manager: “During our call, he (Peng) expressed to me that the call you and I made on him in May really upset him. He took issue with some of the information you expressed to him about MTX: its safety and relative cost. He felt that the data was not properly represented. He stated that he has always had a lot of respect for Amgen and thinks that Enbrel is the best biologic. However, he thought that some of the claims you were making were not what he had come to expect from Amgen.”

His district manager, Sonya Grant, is the same Amgen manager who allegedly urged reps to pull patient files in physician offices so coding could be used to solicit psoriasis patients. The effort, which you can read about here, raises questions about violating patient privacy and are among allegations of improper marketing made by former Amgen sales reps, who claim they suffered retaliation after complaining about the practices and are now locked in arbitration with Amgen.

Some of those practices, by the way, involved Amgen reps being instructed to coordinate patient-outreach programs in which docs were paid to discuss psoriasis with patients who received mailings that were written by Amgen, and sometimes mailed by Amgen reps. One former rep - Marc Engelman - alleges the patients targeted were those with mild psoriasis, even though Enbrel was approved only for moderate to severe psoriasis.

Unlike some other docs who allegedly had no trouble allowing patient files to be pulled and solicitations mailed, USC’s Peng (in the photo at left) was put off by Amgen’s hard sell, which is the kind of behavior that interests the New Jersey attorney general, the Florida attorney general and the US Senate Finance Committee.

In response to messages, Peng wrote back to thank us for “your efforts to ensure that pharmaceutical companies hold to ethical and honest standards of marketing.” But he declined to discuss the episode.

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In fact, the agency is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators, The New York Times reports.

Computer systems are so inadequate that it can only guess the number of the plants, and can’t produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where FDA. inspections are few. The findings come from a series of reports by the Government Accountability Office scheduled to be released at a hearing at 10 am EST today of the House Energy and Commerce Committee’s subcommittee on oversight and investigations. (Here’s the witness list, and you can watch by going here).

The reports and a recent assessment by the agency’s Science Board conclude that the FDA is so overwhelmed by a flood of imports that it is incapable of protecting the public from unsafe drugs, medical devices and food. “This is a fundamentally broken agency, and it needs to be repaired,” Peter Barton Hutt, a former top lawyer with the agency who will testify Tuesday before the committee, tells the paper.

In the last 14 years, the FDA lost 1,311 employees and nearly $300 million in appropriations to inflation while Congress has passed more than 100 laws defining or expanding its regulatory responsibilities. The agency now regulates about $1 trillion worth of goods, or 25 cents of every dollar spent by consumers. And while 80 percent of the nation’s drug supply is now imported, the FDA last year inspected only 30 of more than 3,000 foreign drug plants, the Times notes.

UPDATE: During the hearing, Gail Cassell, a Lilly vp and head of the agency’s Science Board, tells the committee “we have concluded that American lives are at risk. Without urgent action, injury and death are certain.”

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They’re lining up. First, the House Energy and Commerce Committee, then the Senate Finance Committee and then the New York Attorney General begin investigations into the handling of the controversial Vytorin trial. Now Richard Blumenthal, Connecticut’s attorney general, has joined the parade of lawmakers probing how Merck and Schering-Plough handled the study data and the marketing of the expensive cholesterol med.

“We are investigating whether state funds were spent on false assurances about the safety and effectiveness of these drugs,” Blumenthal tells The Wall Street Journal. He’s referring to Vytorin and Zetia, which Merck and Schering co-market in a joint venture. The state’s Medicaid program was the main public source of money spent on the drugs, although he didn’t offer a specific amount.

The Vytorin study has attracted enormous attention because the drugmakers delayed results for nearly two years; briefly changed the primary endpoint without consulting their lead investigator; named an independent panel to review data without releasing names and three panel members were later learned to have financial ties; and some Schering-Plough execs sold lots of stock during all this time.

The FDA, meanwhile, is also reviewing the data, which showed Vytorin lowered LDL cholesterol better than the much cheaper Zocor - which like Zetia is part of the Vytorin combo therapy - but didn’t reduce plaque in the carotid artery.

Rise and shine. Another day, another deadline, or another bunch of meetings, or another project to complete. It’s always something. So to help you along, we’ve gathered a few items. Grab the coffee or the tea and catch up. Have a good one…

A Nigerian court adjourned legal proceedings against Pfizer, Agence France-Presse reports. A criminal case was adjourned a criminal case until Feb. 4 due to the absence of the judge and three of Pfizer’s Nigerian employees, who were summoned by the the court, were also absent at the hearing. Las month, the court had issued arrest warrants for them for ignoring earlier summons. Separately, the Kano state high court on Monday adjourned the civil case against Pfizer to March 3 when the prosecution and the defence would be expected to argue on the court’s jurisdiction in the matter. The charges stem from a controversial clinical trial of Pfizer’s meningitis drug, Trovan, that was carried out in the northern Nigerian city of Kano in 1996. The government alleges Pfizer officials played crucial roles in the clinical trial, which resulted in the deaths of meningitis patients.

The nation’s largest pediatricians’ group wants ABC to cancel the first episode of a new series because it perpetuates the myth that vaccines can cause autism, The New York Times reports. ABC’s new drama, ”Eli Stone,” debuts on Thursday and features a lawyer who argues in court that a flu vaccine made a child autistic. His client, an exec at the fictional vaccine maker, didn’t allow his own child to get the shot. A jury offers the exec a big award. The American Academy of Pediatrics says: ”A television show that perpetuates the myth that vaccines cause autism is the height of reckless irresponsibility.”

Data from ongoing colon cancer therapy studies could shift the cancer drug market, analysts say, as some drugs appear more effective at treating patients who have the K-ras gene, which is typically associated with cancer, The Boston Globe notes. In an investor note, Rodman & Renshaw analyst Michael King writes that Amgen’s Vectibix, ImClone’s Erbitux, and OSI Pharma’s Tarceva could gain broader use based on new data. The colon cancer treatments are part of the ongoing attention given to the K-ras gene and info showing it’s a good determinant of how well a patient will respond to the class of drugs called EGF receptor inhibitors.

One other thing, we initially forgot to note that Amylin Pharmaceuticals reported a widened fourth-quarter loss after Monday’s market close but surprised investors with stronger-than-expected revenue and sales of its Byetta injection for type II diabetes. You can read more in TheStreet.com.