pharma

AstraZeneca asks judge to nullify $215M drug-price lawsuit

Thu, 12 Jun 2008 06:59:56 -0400

Drugmaker AstraZeneca has asked an Alabama judge to nullify a jury verdict that ordered it to pay the state $215 million in damages in a Medicaid drug-price fraud suit. The state's 2005 suit accused the pharma with overcharging Medicaid by inflating drug prices. The jury awarded the judgment in February, but AstraZeneca appealed, saying that the state's attorneys hadn't proved their case, and had also violated a state law capping punitive damages. If the current judge doesn't throw out the verdict, the firm will appeal the judgment to the state's Supreme Court.

To learn more about the case:
- read this Modern Healthcare article (reg. req.)

Related Article:
Drugmakers cut deals in price-inflation lawsuit

Pharma gift disclosure law wins Eli Lilly support

Wed, 14 May 2008 06:59:58 -0400

While its peers appear to be firmly opposed to such rules, pharmaceutical giant Eli Lilly has decided to support federal legislation that would require drugmakers to disclose payments to doctors. Although such initiatives have floundered in the past, Lilly's support may give the new law--which would go into effect beginning March 31, 2011--a better shot at passing.

Lilly got on board with The Physician Payments Sunshine Act, as the measure is known, when legislators agreed to raise the minimum reportable payment from $25 to $500, and extended the legislation to apply to all drug and medical devicemakers rather than only those with more than $100 million in annual revenue.

Another factor that swayed Lilly is that the federal law would pre-empt similar laws currently in affect in a few states. Lilly president John Lechleiter has said that such pre-emption was important, as it would help companies like his by establishing one uniform reporting standard.

To learn more about the bill, and Lilly's position:
- read this Associated Press piece
- read Lilly's statement on the subject

Related Articles:
Drug companies plan to disclose grant funding
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Doctors weigh in on the pros and cons of accepting drug/device freebies

ALSO NOTED: Plavix copycat on the rise in Europe; Hospital bills for services to dead patient; and much more...

Fri, 09 May 2008 06:59:50 -0400

> Pharma giants Sanofi-Aventis and Bristol-Myers Squibb are preparing to battle a copycat generic to its Plavix brand. FiercePharma

> Talk about a nasty billing conflict: A deceased patient's husband and the hospital that cared for her went through a months-long wrangle over services delivered after his wife died. FierceHealthFinance

> Experts are wondering whether vaccines can provide immunity in the absence of natural exposure to those diseases. FierceVaccines

> California hospital upstart Prime Healthcare has joined the Premier healthcare alliance to begin reporting quality data. Article

And Finally... Wow. People will do just about anything for pizza. Article

Trend: Medical schools discourage use of demeaning slang

Wed, 07 May 2008 06:59:55 -0400

Getting through medical school is a tough indoctrination into a close-knit fraternity, so it's no surprise that people develop their own culture. One aspect of that culture is the adoption of workplace slang. Unfortunately, medical educators say, these are often terms that would offend patients if they knew what the terms meant. Calling a patient a "rock" (who is neither getting better nor worse, but staying 'stuck' in the bed) or referring to patients as "that gallbladder in room 208" is bad enough; suggesting that a dying patient is "circling the drain" may be worse. These terms may serve to vent frustration or simplify the care process, but it also takes the focus off the humanity of patients, says Gregory Makoul, director of Northwestern University School of Medicine's center for communication and medicine. To address these concerns, schools are increasingly discouraging students from adopting jargon that might demean patients, or ideally, any jargon at all.

To learn more about this trend:
- read this Chicago Tribune piece

Related Article:
Study: Med school pharma limits affect attitudes

College group urges ban on drug, devicemaker freebies

Mon, 28 Apr 2008 06:59:58 -0400

The association representing U.S. medical colleges has come out with a proposed ban on pharma and device-maker gifts on medical college campuses. The group, the Association of American Medical Colleges, would like to prevent drug and medical device companies from handing out free food, gifts, travel and ghost-writing services on these campuses, not only to doctors, but also to staff members and students. To protect patients who need free samples, it's recommending that medical schools set up centralized systems for accepting the samples.

The group also thinks med schools should discourage their faculty from participating in industry-funded speaker's bureaus, under which doctors get paid to promote the benefits of key drugs and devices. While any of the nation's 129 medical colleges would be free to ignore the proposal, most are likely to follow its lead, observers say.

To learn more about the proposal:
- read this article in The New York Times

Related Articles:
MA lawmakers mull ban on pharma gifts to doctors
NJ mulls pharma, device maker gift reporting
Reader feedback: Is limiting industry gifts a smart policy?
NY bill would require pharmas to report MD gifts

Louisiana MDs win legal battle over patient record disclosure

Fri, 18 Apr 2008 06:59:56 -0400

A group of Louisiana physicians have won their battle to keep their patients' records out of the hands of a pharmaceutical company--though they may face future challenges on the issue. The dispute comes as part of the Louisiana attorney general's suit against Janssen Pharmaceutic, which the state says has been illegally promoting off-label uses of Risperdal. The AG also is arguing that in so doing, Janssen defrauded the state's Medicaid program. Though no doctors or patients are parties to the suit, Janssen got a court order allowing it to subpoena physicians for the medical records of up to 6,000 Medicaid beneficiaries who received Risperdal prescriptions. The order also allowed the pharma to depose individual doctors on their Risperdal prescription decisions. However, the state's physicians contested the order, with judges concluding that Louisiana's laws governing medical privacy would invalidate the request.

To learn more about the case:
- read this AMNews article

Related Articles:
Lilly accused of promoting off-label Zyprexa use
Schering fined $435M for off-label marketing
Health plans target off-label use
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SPOTLIGHT: Survey: Direct-to-consumer pharma ads work

Wed, 05 Mar 2008 06:59:52 -0500

A new study confirms what most of us suspected already: that pharma direct-to-consumer advertising works. According to the study, nearly one-third of Americans ask their doctors about a drug they've seen in an ad, and 82 percent get a prescription. What's more, 53 percent of patients surveyed said that drug advertising is mostly a good thing. Article

Who will pay for DTC pharma ad oversight?

Mon, 25 Feb 2008 06:59:54 -0500

Right now, there's a little-watched debate underway on the Hill which could have a meaningful influence on the growth of direct-to-consumer pharma advertising. The question is whether Congress should continue to fund such oversight, or whether the pharmas should fund DTC ad reviews with "user fees." Officials with the FDA, which has a $6.1 million budget for determining the accuracy and fairness of DTC ads, are concerned that it won't have enough funding to review the growing influx of ads. Right now, it has 13 employees who review the ads, but they were swamped with a staggering 12,616 ads to review last year.

To boost employee rolls, President Bush has requested $14 million in user fees from the pharmaceutical industry in his FY 2009 budget. The problem with having the pharmas fund the research, critics say, is that this might give them undue influence over the process.

To learn more about the debate:
- read this Kaiser Daily Health Policy Report item

Related Articles:
FDA expected to announce review of review of DTC ads. Article
FDA begins study of images in drug ads. Article

FDA rules on off-label article distribution issued

Wed, 20 Feb 2008 06:59:57 -0500

The FDA may soon be loosening its guidelines for distribution of journal articles discussing unapproved uses of approved drugs and devices, a move which some consumer advocates (and some legislators) say would all but open the floodgates to off-label marketing. The rules, which are in their comment period, will soon become final.

Under the previous rules, which actually expired in 2006, the FDA had some fairly tough standards in place. If pharmas and device-makers wanted to distribute journal articles promoting off-label uses of their products, they had to submit the articles to the FDA in advance for approval. What's more, they had to file a supplemental new drug application for the use they wanted to promote within three years of doing so. The new draft guidelines don't impose these limits, though they recommend against distributing articles funded by one of the manufacturers of the products discussed. All told, it sounds like the new FDA rules are a big step away from where they were in the past. With hard-and-fast rules being softened into "recommendations," it's hard to imagine that pharmas or device-makers will bother to follow them. After all, there's a ton of money to be made on off-label use of these products, which are, after all, more common than approved uses. The question is, is it more likely that someone will be hurt by an inadequately researched off-label prescription under the new system?

To learn more about this issue:
- read this Modern Healthcare piece (reg. req.)
- read this FiercePharma piece

Related Articles:
Too much off-label regulation? Report
Rep decries off-label marketing "loophole." Report
Did pharma ask the FDA for off-label rule change? Report
New warning for off-label Fentora. Report

Merck agrees to pay$650M+ to settle suits

Fri, 08 Feb 2008 06:59:58 -0500

Merck has agreed to pay more than $650 million to settle two whistleblower suits, the U.S. Justice Department has announced. One of the suits claimed that the pharma paid providers to use its products, disguising kickbacks as compensation for training, consulting and market research. The other suit claimed that Merck gave hospitals volume discounts on Zocor, Vioxx and Pepcid while failing to offer Medicaid the same discounts. (Nevada, for example, concluded that Merck was charging hospitals less than 8 percent of its reported price on Zocor, while failing to give the state's Medicaid program the same price.) Former Merck sales manager H. Dean Steinke will get about $68.2 million for his role in the suits, while the other whistleblower, New Orleans physician William LaCorte, will receive $24.1 million.

To learn more about the suit:
- read this Modern Healthcare article (reg. req.)

Related Articles:
Providers settle whistle-blower suits. Report
Merck posts $1.6 billion loss. Report
Merck settling Vioxx claims for $4.85B. Report