Hello, everyone. We apologize for the absence this afternoon, but we had an interesting meeting with an industry type. Every so often, we do try to escape the confines of the Pharmalot corporate campus. Now, though, we are playing catch up and want to leave you with these few items. Have a good night and see you tomorrow. Cheers…

Bristol-Myers Cuts DeWitt Workforce (Central New York Business Journal)

Cigna Cuts Lipitor Cost By Half (Bloomberg News)

FDA Panel Backs Novartis Malaria Drug (Reuters)

That’s the charge by a watchdog group known as The Prescription Project, which today petitioned the FDA and asked the agency to enforce its rules by requiring Abbott Labs, Medtronic and Stryker to withdraw YouTube.com video ads for medical devices used in heart, hip and neck surgeries (see full petition and videos here).

The group claims that four Abbott videos on YouTube promote its XIENCE V drug-coated stent for use in coronary angioplasty surgery, but fail to mention federally-mandated warnings. Similarly, the Medtronic videos tout the use of its Prestige Cervical Disk for surgery for degenerative disk disease and the Stryker video promotes its Cormet hip resurfacing technology without required warnings.

“The videos raise serious questions about whether drug and device companies are using the Internet to skirt laws that safeguard consumers,” Allan Coukell, director of policy for the Prescription Project, says in a statement. Here is the Abbott petition, the Medtronic petition and the Stryker petition.

The group is calling for the FDA to advise drug and device makers that online and Internet ads and promotions are subject to the same requirements pertaining to other media, and recommend they conduct compliance reviews. They also want the agency to issue a “Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet” to clarify how federal law and FDA regs applying to online drug and device promotions.

We await comment from the device makers. UPDATE: A Stryker spokesman declines to comment. We have still not heard from Abbott. But a Medtronic spokesman writes us this: “We are committed to U.S. Food and Drug Administration guidelines on direct-to-consumer advertising. Unfortunately, Medtronic content also can be posted to other web sites by third parties. The video in question has been removed from the Internet. Any additional video produced by, or on behalf of, Medtronic that does not comply will be addressed immediately.”

Once again, the TV drama makes a bid for being renamed Boston Pharmaceutical. In the latest episode of this dressed-up soap opera, a leading character at the Brahmin law firm played by William Shatner is diagnosed with moderate Alzheimer’s and wants to get an experimental Pfizer drug, which appears to be Dimebon.

But Shatner is denied - his doctor won’t get the drug for him and the clinical trial appears to be closed. And so he goes to court, where the judge is sympathetic: “A patient, even a dying patient, has no constitutional right to an experimental treatment. Do I agree with that precedent? Not really.” Even so, she boots the case, which the US Supreme Court agrees to hear, although in real life, we know the court earlier this year refused this morning to review a ruling that terminally ill patients have no constitutional right to be treated with experimental drugs (back story).

Another plot running through the episode involves a young woman who sues Harvard University, because she was denied admission after it became known she used Ritalin to boost her chances of getting high SAT scores. The university admissions officer tells the court that a ‘moral’ decision was made about the use of ‘brain-enhancement drugs.’ One of her defenders admits to the court that he also uses medication to get through the day and declares that we are an overmedicated society.

Maybe. But meds certainly make for good drama these days. Two months ago, Boston Legal mentioned an unnamed Harvard Univerity psychiatrist who helped fuel the boom in antipsychotics for kids and took more than $1 million from drugmakers, but failed to report the income to his employer. Sound familiar? The US Senate Finance Committee is investigating several academics for allegedly violating disclosure rules.

{To watch the latest episode, please go to this link, although you may need to install a plug-in).

When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Hardy is British, and UK health authorities refused to buy the drug. If the Hardys lived in the US or another European country, he would most likely get the drug, although he might have to pay part of the cost, The New York Times writes about the UK controversy over paying for meds.

A clinical trial showed the Pfizer pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000. But at that price, Hardy’s life is not worth prolonging, according to the UK’s National Institute for Health and Clinical Excellence, which has decided that, except in rare cases, the government can only afford about $22,750 to save six months of a citizen’s life.

After substantial protest, UK authorities are reconsidering decisions on various drugs, after years of being almost alone in using evidence of cost-effectiveness (back story). But skyrocketing prices have led more countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer. Top health officials in Austria, Brazil, Columbia and Thailand say NICE strongly influences their policies (click on the chart to enlarge).

“All the middle-income countries - in Eastern Europe, Central and South America, the Middle East and all over Asia - are aware of NICE and are thinking about setting up something similar,” Andreas Seiter, a senior health specialist at the World Bank, tells the Times.

Read more »

The prominent research center is about to publicly report business relationships between any of its 1,800 staff doctors and scientists have with drug and device makers, The New York Times reports.

The move appears to be the first such step by a major medical center to disclose such relationships and, as the Times writes quite pointedly, comes as doctors and hospitals are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.

The disclosures, which will be made on the organization’s web site, are part of an effort to address conflict-of-interest issues after some of its leading docs came under fire several years ago following reports of financial links, the paper continues. The clinic’s work for drugmakers, for instance, has been used to criticize, Steve Nissen, who chairs the clinic’s cardiovascular medicine department but says any payments are given away as donations.

“They are breaking a new path here,” David Rothman, the president of the Institute on Medicine as a Profession, a nonprofit group based at Columbia University that studies potential conflicts of interest, tells the Times.

Read more »

Goldman Sachs is in talks to provide hundreds of millions of dollars of funding to a large drugmaker, in what appears to be an attempt to create a new business model that will see financing shifting towards co-development of specific meds, The Financial Times reports.

Jon Symonds, managing director at the investment bank in London and former finance director at AstraZeneca, says a first deal to create a new hybrid model of R&D should be finalized early next year and reflected the desire for even large drugmakers with strong sales on existing drugs to seek funding for future development, according to the FT.

The Goldman Sachs model would form a “research pool” into which drugmakers would place a range of experimental drugs in a single therapeutic area in early-stage phase 1 and 2 trials, where their staff would work alongside external experts including scientists, chemists and clinical research organizations. The hope is to create more flexible, transparent and cheaper drug development, freed from large bureaucracies and heavy overheads, while sharing risks with outside partners.

He explains the model would potentially allow competing drugmakers working on similar drugs and duplicating research areas to pool resources. “If we deliver one, there is huge appetite because capital is in pretty short supply,” he says.

Read more »

This likely does not come as a surprise, given that FDA staff reviewers raised concerns about allergic reactions last spring (back story) and the agency subsequently issued a ‘not approvable’ letter this past summer (back story). Additional trials were expected and this has now been confirmed.

In a posting on its web site late yesterday, Schering-Plough wrote that “in order to address issues which primarily related to hypersensitivity/allergic reactions, the company plans to conduct an allergy sensitivity trial in healthy volunteers that will include repeat exposure to sugammadex. The study protocol is being developed, and the company anticipates conducting the trial in 2009.”

There was no info, though, on exactly when the trial should be completed and, if successful, when FDA approval for the drug, known as Bridion or sugammadex, might occur. The FDA rejection undercut Schering-Plough’s decision to pay $14 billion for Organon, where the drug originated. Schering-Plough repeatedly pointed to Bridion as one of several key reasons for the deal and some Wall Street analysts had forecast annual sales for the drug of up to $1 billion.

You may recall that, last week, Schering-Plough touted the drug as one of five “stars” of its research pipeline at a meeting with investors. UPDATE: Now, Leerink Swann analyst Seamus Fernandez says Schering-Plough was now unlikely to seek FDA approval before 2010, according to Reuters.

Hat tip to Shearings Got Plowed

For those of you who like to watch the comings and goings at the highest ranks at the drugmaker, we thought we would share with you the memo sent by Pfizer ceo Jeff Kindler to announce the impending departure of one of the more visible faces on his team.

As chief medical officer for the past decade or so, Feczko was involved with numerous efforts to champion such drugs as Viagra, Chantix and Celebrex. He was also on hand when Pfizer scuttled development of the torcetrapib cholesterol pill. Prior to his run as cmo, Feczko was senior vp for medical and regulatory operations for global pharmaceuticals (a brief bio). He leaves in a few months after a search for a replacement is conducted.

Dear Colleagues,

After 22 years of leadership in advancing Pfizer science - and 26 years total in the global pharmaceuticals business - Joe Feczko, our Chief Medical Officer and a member of the ELT - has decided to retire. I want to take this opportunity to reflect on some of Joe’s career achievements and to extend our heartfelt thanks to him for his work on behalf of our company, customers and patients.

Read more »

‘Tis the middle of the week and that can mean only one thing - the need to dig out from under meetings, deadlines and projects. To help you cope, we have unearthed a few items of interest. Hope your day goes well, no matter what…

Merck Shifts Seattle Chief To Boston Lab (Bio-ITWorld)

Gardasil Allergic Reactions Are Uncommon: Study (Yahoo/Reuters)

Glaxo To Cut 200 Jobs At UK Plant (BBC)

Asthma Sufferers Concerned Over New Inhalers (Arizona Republic)

Despite concerns expressed by some doctors and patients that generics are inferior products, there is no evidence brand-name meds are clinically superior, according to a meta-analysis of 47 studies of various cardiovascular drugs published in the Journal of the American Medical Association.

Researchers from Brigham and Women’s Hospital in Boston looked at studies published from 1984 to August 2008, as well the content of editorials published during that time to gauge expert opinion. Of the 47 articles, 38 (or 81 percent) were randomized controlled trials, according to a JAMA statement. Here’s what they found…

Clinical equivalence was noted in 100 percent of RCTs of beta-blockers; 91 percent of RCTs of diuretics; 71 percent of RCTs of calcium-channel blockers; 100 percent of RCTs of antiplatelet agents; 100 perent of RCTs of statins; 100 percent of RCTs of angiotensin-converting enzyme (ACE) inhibitors, and 100 percent of RCTs of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT of class 1 anti-arrhythmic agents and five out of five RCTs of warfarin.

Meanwhile, of 43 editorials and commentaries that met study criteria, 23 (or 53 percent) expressed a negative view of the interchangeability of generic drugs compared with 12 (or 28 percent) that encouraged generic substitution (the remaining 8 did not reach a conclusion on interchangeability). Among editorials addressing NTI drugs specifically, 12 (or 67 percent) expressed a negative view while only four (or 22 percent) supported substitution.

“One explanation for this discordance between the data and editorial opinion is that commentaries may be more likely to highlight physicians’ concerns based on anecdotal experience or other nonclinical trial settings. Another possible explanation is that the conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed. Approximately half of the trials in our sample (23/47, 49 percent), and nearly all of the editorials and commentaries, did not identify sources of funding,” the researchers wrote.

Read more »