Lexicillin QD

AHCJ sponsors seminar on conflict of interest issues involving Big Pharma

Besides this discussion about the conflicts of interest involving Big Pharma and clinical studies and how they are reported, I think it's important for journalism student to get a basic grounding in medical statistics and clinical study design. I think I'll mention this to Jeff Jarvis who runs the program who is an Associate Professor at the CUNY J-school to see if he agrees.

The e-mail I received this am:

The Association of Health Care Journalists -- Metropolitan New York Chapter invites you to attend a special program on November 5th: CONFLICT OF INTEREST IN HEALTH CARE: HOW TO SPOT IT, WHAT TO DO ABOUT IT

The drug industry finances research, conducts clinical trials, and doles out "unrestricted educational grants." But as health journalists, we confront a number of questions: Is there really a difference between marketing and education? How does Big Pharma's gift giving to doctors affect their prescribing habits? Can you tell if pharma-sponsored studies are manipulated? How many of your sources have received honoraria or speaker's fees from the industry? Is it ethical to write about a drug company you invest in? Share an informative evening with your health journalism colleagues. Find out how to unearth potential conflicts of interest when reporting on drug treatments -- and what to do once you've uncovered them.

Where:    CUNY Graduate School of Journalism    

230 West 41 Street between 7 & 8 Avenues

When:  Monday, November 5, 6 to 8 pm

MODERATOR Scott Hensley,Editor, Wall Street Journal Health Blog

PANELISTS
Alex Berenson,  Business Reporter, New York Times; Author, "The Faithful Spy: A Novel" (Random House, 2006)

Ed Silverman, Editor, Pharmalot A Star Ledger of New Jersey website [No, it's a blog.]

Joanna Breitstein, Executive Editor Pharmaceutical Executive Magazine

Fran Hawthorne, Author  "The Merck Druggernaut" (John Wiley & Sons, 2003) "Inside the FDA: The Business and Politics behind the   Drugs We Take and the Food We Eat" ( John Wiley & Sons, 2005)

EU approves the Norvartis DPP-4 inhibitor vildagliptin (Galvus)

Novartis is expected to re-submit the once-daily oral drug to the FDA some time before 2009, and to answer concerns about the skin lesions seen in monkeys during a clinical trial. It received an approvable letter for the drug last year.

Although it's forecasted that this drug could achieve more than $1 billion in annual sales, there are about a year behind Merck's sitagliptin (Januvia) which is currently on the market in the US.



Bloomberg.com: Health Care

Technorati Tags: Galvus, vildagliptin, Januvia, sitagliptin, Novartis, Merck,

Novartis using share buybacks to float stock price; dire reports on Prexige and Galvus

[Novartis] is going to spend up to 100% of its free cash flow after dividends and acquisitions on share buybacks in an effort to keep the stock price up. Its previous target for buybacks was up to 50%.

"If you want my personal opinion, I don't expect we'll get approval," says Novartis chief Dan Vasella about his Cox-2 inhibitor Prexige. Along with, "We had a significant number of disappointments."

This comes up top of news that Galvus won't be resubmitted to the FDA until 2009. At one point it looked as if Novartis would beat Merck to market with the first incretin inhancer. Now, Merck's hot selling Januvia has no competition in this drug class.

Health Blog

Technorati Tags: Novartis, Galvus, Prexige, Vasella

Researcher Clifford Rosen challenges the FDA approval process

He's saying that not only should drugs show efficacy with the surrogate markers, such as A1C with the type 2 diabetes meds, but they should also be proven to "enhance long-term quality of life by reducing risks for such serious
side effects as heart attacks, eye and kidney ailments, and amputations."

His opinion, based on his experience as chair for an FDA advisory panel considering Avandia heart risks that emerged eight years after FDA approval, was published as a commentary in the NEJM

Burden of proof - The Boston Globe

Technorati Tags: Rosen, FDA, nejm

Alnylam & Isis = Regulus

Link: WSJ Health Blog : Old RNA in New Bottles?

This is about the announcement that Alnylam Pharm. and Isis Pharm., both big players in the very hot field of RNA interference (RNAi), are launching their joint venture called Regulus.

RNAi is a natural process of gene silencing. The cell uses microRNA (miRNA) to stop the production of protein encoded by a particular gene. In the case of cancer, oncogenes can overcome this inhibition, producing a glut of disease-causing proteins.

The level of naturally occurring miRNA can be raised to help control cancer, or synthetic short interferring RNA (siRNA) can be created for the same purpose.

They've brought in the CalTech Nobel laureate David Baltimore to sit on the board and chair an advisory group.

These companies have a history of collaborating on miRNA technology. Since 2004, they've jointly licensed IP relating to the therapeutic uses of miRNA from the Max Plank society.

Novartis's Tekturna study suggests lower BNP levels

This is the Novartis renin inhibitor for treating hypertension. "Tekturna, known generically as aliskiren, recently went on sale in the United States and was approved last month in Europe, where is it goes under the name Rasilez."

John McMurray of the University of Glasgow, Scotland, said a 300-patient study of patients with heart failure found Tekturna significantly cut levels of B-type natriuretic peptide (BNP), a biomarker associated with worsening outcomes for patients.

To Pharma TV or not TV

This a PDF produced by PharmaVoice about some initiatives that would seek to ban all DTC pharma advertising.

   A DVD created by the European Federation of Pharmaceutical Industries and Associations (EFPIA) ignited unfounded rumors that the industry was preparing to challenge the current ban on DTC advertising in Europe. Although untrue, the allegations sparked a robust discussion around innovative initiatives that can be used to educate patients and consumers.
    On May 21, 2007, The Guardian, a British-based newspaper, reported that Johnson & Johnson, Pfizer, Novartis, and Procter & Gamble were proposing to launch television programming in Europe that would be featured on a dedicated interactive digital channel funded by the industry with health news and features and information about drugs. The Guardian reported it viewed a pilot DVD produced by J&J called the European Patient Information Channel. According to J&J sources and others, The Guardian misunderstood the intent of the presentation...

Pioglitazone, sitagliptin, and exenatide may benefit from rosiglitazone CV risks

The WSJ's health blog has an article "Pharma Box Office: Diabetes Drugs" which speculates that other recently developed non-insuline therapies for type 2 diabetes, the incretin mimetic exenatide, and the incretin enhancer sitagliptin, may take a higher profile considering the meta-analysis suggesting increased CV risks associated with rosiglitazone.

Merck’s push behind diabetes pill Januvia [sitagliptin] and Janumet (a combination [of sitagliptin] with generic diabetes medicine metformin) accounted from 36% of the contacts, or details in industry parlance, that sales reps made with primary care doctors who write the most prescriptions in April, ImpactRx data show. Merck’s U.S. sales of the medicines for the four months ending in April were $115 million, according to data from Wolters Kluwer Health.

Lilly and Amylin's exenatide, lauched 2 years ago, has had sales of $221 million through the end of April.

Takeda Pharmaceuticals’ Actos drugs [pioglitazone, along or in combination with metformin], the closest chemical competitors to Avandia, got 23% of details in the month. U.S. sales of the Actos franchise were $988 million through the end of April, Wolters Kluwer’s data show.

Novartis is still working on resolving an FDA approvable letter regarding vildagliptin and additional studies needed to resolve possible renal dosing issues.

Technorati Tags: diabetes, pioglitazone, sitagliptin, exenatide, metformin

AstraZeneca in the news

The first is the announcement that it is acquiring MedImmune for $15.2 billion. This comes as AstraZeneca is reporting the failure of its fourth experimental drug within the last year. According to this Bloomberg.com article, this price is 11x MedImmune's sales.

MedImmune's Synagis and FluMist will add about $1.2 billion in sales, and the purchase will add to profits starting in 2009, AstraZeneca said. MedImmune also gets royalties from cervical cancer vaccines sold by Merck & Co. and GlaxoSmithKline Plc. The acquisition enables AstraZeneca to meet its target of a quarter of all development projects coming from biotech products from 2010.

On another front, Dr Rost is continuing his coverage of...

...the "Arimidex/Faslodex," "Pharmaceutical Sales Specialist Objection Handler for the Tablet PC," which is a CD that was mailed to the AZ oncology sales force in January 2007.

Two of the audio tracks show exactly how to sell AZ's Arimidex against Novartis' letrozole (brand name FEMARA), by minimizing the efficacy message of letrozole, WITHOUT HAVING ANY COMPARATIVE DATA.

Tags: AstraZeneca, MedImmune, Arimidex, Femara

Analysts upgrade Merck despite Arcoxia disappointment

The WSJ is reporting that analysts were expecting the worst with the FDA committee vote on Arcoxia. Before the vote, a Deutsche Bank analyst is quoted, "We sort of view Arcoxia as dead and we don't have any estimates for it."

But, Merck seems to be doing well despite the Arcoxia disappointment. Their Q1 earnings will be 84 cents and share, well above the 64 cents expected. Plus, some of their recent products have a bright future:

Goldman Sachs, citing Merck’s cervical cancer vaccine Gardasil and diabetes drug Januvia, upped its rating on Merck from sell to neutral, and Merrill Lynch raised its price target for the stock.

There's other potentially good news for Merck: "A ruling from a Texas judge coming as soon as Monday is expected to undercut the legal foundation for all 1,000 Vioxx cases brought against Merck by Texas plaintiffs...."

Tags: Merck, Arcoxia, Januvia, Janumet, Vioxx, Gardasil