As tens of thousands of people file in to Denver next week for the Democratic National Convention, one of the many executives lurking about will be none other than the Pfizer ceo. And while he is not expected to address the crowd at Invesco Field, home of the Denver Broncos football team, Jeff will be busy creating a platform for himself as an influential health care policy expert.

On Monday, for instance, he will participate in one of the Rocky Mountain Roundtable discussions at the Denver Performing Arts Complex to hash out the myriad problems with the nation’s health care system, along with the mayors of Boston and San Francisco, the governor of Colorado, and execs from United Health and the Mayo Clinic, among others. The $12 event is sold out. Sorry.

Kindler, you may recall, is a regular contributor to the Democratic Party, and while he backed Hillary Clinton, he fancies himself as the kind of ceo who can successfully execute important policy goals on a wider playing field. And what better forum to raise your profile than the convention?

Of course, plenty of ceo’s hang out at conventions and advancing Pfizer’s cause before politicians who are likely to influence the company’s fortune is important. And so a Pfizer spokesman sends us this comment: “Pfizer leaders will attend both the Democratic and Republican conventions, to advance the discussion on health care reform with key stakeholders and ensure our company positions on this and other policy priorities are well-represented.”

Still, wouldn’t it be interesting if Jeff impresses the right people with his creds? Let’s see now, which jobs will soon be open? Hmm…. How about FDA commissioner? Then again, let’s not say anything. We wouldn’t him to get a big head.

Is it possible? Have Vytorin prescriptions finally hit bottom? Maybe. Back in January, when preliminary results for the Enhance trial were released, scrips were about 1.8 million, but then sunk to 1.33 million in June. Last month, though, scrips rose about 90,000, according to a filing by Schering-Plough with the Securities and Exchange Commission. This happened despite the confusion over the recently released Seas trial, which failed a primary endpoint and, moreover, yielded a puzzling number of cancer cases.

However, there is another way to slice the data (isn’t there always?) Although scrips were up for Vytorin and Zetia, both of which Schering-Plough and Merck co-market in a rather strained joint venture, scrips for the entire cholesterol market also rose to their highest levels since January. You know the rising tide theory…

And so Vytorin’s share of the overall cholesterol market, which stood at 9 percent in January and 6.9 percent in June, fell to 6.6 percent last month. The drugmakers’ combined ‘franchise,’ which amounted to 15.2 percent of the cholesterol market in January and 12.1 percent in June, slid to 11.7 percent last month. Meanwhile, the gossipy reps who love to dish at CafePharma, that electronic bathroom wall, say Schering-Plough is playing musical sales teams to boost scrips. How low can you go?

Nice to see you again. As we ease back into our routine after a long-needed and enjoyable vacation, we are struck by the ongoing pace of events. For those who missed it yesterday evening, please scroll down to read the latest report in the Annals of Internal Medicine about a Vioxx ’seeding’ study. Meanwhile, we are readying ourselves for another day. Hope yours goes well…

Appeals Court To Hear Accutane Lawsuit (Associated Press)

Novo: No Rise In Pancreatitis From Experimental Drug (Reuters)

Medco And FDA To Study Genetics In Prescribing (The Wall Street Journal)

Dishman To Supply Bulk Drugs To Merck & AstraZeneca (Reuters)

A 1999 Merck study of Vioxx, which was touted to participating doctors and patients as easier to stomach than another drug, was primarily a stealth marketing strategy, according to a report in The Annals of Internal Medicine, the Associated Press writes. Here it is.

The true purpose was to get lots of docs and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs’ lawyers preparing for trials in Vioxx lawsuits, the AP reports.

Drugmakers are widely suspected of doing many “seeding,” or marketing studies, but there’s been no “smoking gun” proving it before, according to the Annals of Internal Medicine, which published Merck’s original report on ADVANTAGE in 2003. Here it is.

An accompanying editorial, co-authored by Annals editor Harold Sox, states the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating Vioxx was better tolerated, the AP adds.

Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, tells the AP that “the ADVANTAGE study was primarily a scientific study” designed and executed by the drugmaker’s clinical research unit and that any later use of data for marketing was a separate operation. Here is an open letter from Merck, the amended protocol for the trial, and Merck’s synopsis of the study.

Read more »

Layoffs and restructurings are taking a toll on drug and device makers in New Jersey, which for decades has prided itself on being home to many of the world’s biggest such companies.

However, a survey released today shows employment fell 1 percent in 2007 from a year earlier among the 22 members of the HealthCare Institute of New Jersey. The total state payroll, however, rose 1.3 percent to $7.7 billion, and the statewide economic impact rose 3.8 percent to $27 billion last year. The survey found that members of the group increased R&D spending by 5.3 percent, to $7.9 billion.

Of course, the picture is likely to look very different if Roche succeeds in buying the rest of Genentech and transfers most of its New Jersey operations - including US headquarters and manufacturing - to California (back story and more background on disappearing industry jobs).

The FDA is working on a stronger label for the widely used diabetes drug, which is marketed by Lilly and Amylin Pharmaceuticals after deaths continue to be reported despite earlier government warnings. Six new new reports were received of patients developing a dangerous form of pancreatitis while taking Byetta. Two patients died and four were recovering, the Associated Press reports.

The drugmakers said in a statement that patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” They added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.

The FDA announcement updated an October alert about 30 reports of Byetta patients developing the ailment. Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, which can cause nausea, abdominal pain and potentially deadly complications. More than 700,000 patients worldwide have used the injectable drug since it was launched in June 2005.

In an investor note, Deutsche Bank analyst Barbara Ryan writes that “growth in demand for Byetta has been lackluster in the last couple of years (total prescriptions are up about 7 percent year-to-date) and this development obviously an’t help. The more important question is whether in the current regulatory environment it could impact timelines for development (of a long-acting release formulation). The occurrence of pancreatitis appears to be rare in Byetta users, but in our view, there could potentially be heightened concern regarding pancreatic complications with the longer-acting version of the drug, for which the overall patient database is still fairly small.”

Which drugmaker is projected to replace its thinning pipeline fastest? A new analysis suggests that Schering-Plough, which has suffered this year over clinical trial results for its best-selling Vytorin and Zetia cholesterol drugs.

The above table, courtesy of AVOS Life Sciences, shows the replacement ratio, which the research firm defines as a measurement of how quickly a drugmaker replaces lost sales with sales from new products. This is a direct measure of R&D productivity. In 2012, the top 14 global drugmakers will generate an average of 26 cents from new products (launched during the prior five years) for every dollar lost from declining products. This represents a 65 percent drop from the 2007 level of 77 cents.

Only two drugmakers are projected to maintain a replacement ratio above 1 in 2012 - Schering-Plough (1.58, due to a strong pipeline and minimal patent risk) and Amgen (1.46, due to a portfolio of primarily biologics), according to AVOS.

On the other hand, two drugmakers that rank high in global sales, Roche and Sanofi-Aventis, will fall to the bottom of the rankings in 2012 when it comes to replacing former blockbusters with new, big-selling meds. In fact, AVOS says neither is projected to launch a new product between 2008 and 2012.

Loss of exclusivity is the main driver of the overall low replacement ratio in 2012, with the following major products going off patent: Lipitor (Pfizer), Effexor (Wyeth), Risperdal, (Johnson & Johnson), Zyprexa (Eli Lilly), Topamax (Johnson & Johnson) and Cozaar/Hyzaar (Merck), according to AVOS.

The University of Georgia and a former faculty member stand to make about $70 million from a license on an invention used for the popular Restatis eyedrops, which are sold by Allergan. But for more than a decade, Renee Kaswan, a former professor of veterinary medicine, hs been prodding the institution to be more aggressive in commercializing the invention, The Chronicle of Higher Education writes.

She contends the university would be entitled to substantially more - as much as $230 million in additional cash - were it not for the deal the university’s research foundation cut with Allergan behind her back in 2003, a deal she calls naïve and shortsighted. “They got suckered,” Kaswan tells the paper. The deal allowed Allergan to reduce royalties to the university in exchange for an upfront payment of $23 million and additional payments later.

Sales of Restasis have taken off, but the university is not getting the full benefit because of the 2003 agreement. University leaders have said that their arrangement with Allergan guaranteed the institution a lucrative payday even if the prescription product was later found to be unsafe or was overtaken by a competing drug. The dispute that is now slowly working its way through a state court in Georgia shows why so few university inventions become blockbusters for their institutions.

You can read the background to their ugly dispute right here. A state court judge appears ready to unseal documents showing the arrangement between Allergan and The University of Georgia Research Foundation, which the drugmaker has tried to keep secret, The Atlanta Business Chronicle reports.

Superior Court Judge David Sweat told the Chronicle he will begin the process of unsealing almost all of the documents. A transcript of an April 24, 2007, hearing refers to documents that describe how Allergan orchestrated what Sweat referred to as “a bad deal” for the foundation - one in which it will gain $72 million instead of a potential $294 million, according to an analysis done by Kaswan. We are reaching out to Allergan for comment and will update you when we receive a reply.

Hat tip to PharmaGossip

A federal judge in Texas has ruled that a lawsuit against a device maker can proceed, because preemption - as defined in a closely watched US Supreme Court ruling earlier this year - does not apply in this instance. And the decision suggests device makers may no longer be immune from some cases they have been unwilling to settle.

Here’s some background: Last February, the US Supreme Court voted to 8-1 that patients can’t file lawsuits against device makers when their products were approved by the FDA. Medtronic successfully argued that the Food, Drug, and Cosmetic Act expressly preempts state law claims brought by patients who were hurt by devices that received premarket FDA approval.

The ruling gave device makers an eagerly anticipated defense in product-liability lawsuits and drugmakers are hoping for a similar ruling this fall when the court hears a case involving a Wyeth medication. [Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. Unlike medical devices, however, there is no statute providing for preemption for drugs.]

But in an 8-page ruling last week, US District Court Judge Barbara Lynn wrote that preemption does not preclude a family from pressing a lawsuit against Bionics over two Cochlear devices that were implanted in their son’s ears in 2005. The family charged the implants were adulterated because Bionics failed to use an approved manufacturer for a component; failed to obtain premarket approval for design modifications and manufacturing processes didn’t comply with FDA requirements. The FDA filed suit in 2006.

In her decision, Lynn noted that “the relevant issue here is whether plaintiffs’ strict liability and implied warranty claims impose duties on medical device manufacturers ‘different from, or in addition to’ those arising under the Medical Devices Amendments of 1976, triggering preemption.” She went on to conclude that “plaintiffs’ strict liability claims are predicated solely on violations of federal law,” and as a result, preemption is not warranted.

Forget about distributing medical literature or samples. If sales reps want to engage physicians, they need to develop personal relationships, according to a new survey that measured the effectiveness of sales forces from five drugmakers that sell antipsychotics - Pfizer, Lilly, AstraZeneca, Bristol-Myers Squibb and Johnson & Johnson. How personal? Well, that’s not specified, but use your imagination.

The study identified four segments of physicians: Fully Engaged, Engaged, On The Fence and Disengaged, according to PeopleMetrics Rx. Overall, 31 percent of physicians were Fully Engaged or Engaged, while the largest proportion of physicians - 53 percent - were On The Fence.

And so, the firm advises pharma that “sales representatives must develop personal relationships with their physicians to achieve the highest levels of engagement. In fact, emotional components such as friendship with the reps are the strongest indicators of Fully Engaged physicians. In turn, this has a positive impact on the duration and frequency of meetings and physician prescribing patterns.”

“Our findings will be important for sales forces in pharmaceutical companies,” Gary White, the firms’ executive vp, says in a statement. “Measuring the emotional connection sales reps develop with their physicians is not typically monitored in standard sales force effectiveness research….yet we find that this emotional dimension is key in understanding physicians’ perceptions toward their reps and the pharmaceutical company as a whole.”

So go ahead, tell those reps to ‘hug a doc today.’ Put the saying on a bumpersticker for the fleet of rental cars used by the reps. And throw those studies - whatever their source of funding - in the wastebasket. Just make sure the rep looks like the kind of person a doc would want get to know better.

Hat tip to GoozNews