Pharma’s Cutting Edge

Normally I’d give you a link to the full news story, but in this case I think you’ll find one of the 2300 or so major news-site links on your own. Merck’s lawyers are so far holding to their pre-trial plan to appeal the verdict and the massive punitive damage award. They also claim to have the mandate, the resources and the resolve to try separately each of the 4000+ pending cases. I’m not yet ready to comment on the merits of the case against Merck, the quality of the testimony or the verdict–eventually I will be, after I read a transcript of the proceedings. And I won’t attempt to predict the outcome of the appeal of this case either. I will, however, make one simple prediction on a morning when many Merck emloyees are at home with their loved ones questioning their reasons for joining Merck, for staying there, for staying in the industry anywhere. If Merck is denied an appeal hearing, or if they are granted a hearing and lose the appeal, Merck’s resolve to try all, or even a few, of the pending cases will dissolve as fast as nitro under the tongue. You can bet on it, but then you already knew that.

September is going to be busy for FDA staff as they manage an unusually large number of product-based advisory committee meetings. NDAs (or sNDAs) under consideration include:

Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia (abatacept); Arthritis Drugs Advisory Committee Sept. 6.

Pfizer’s inhaled insulin Exubera and Bristol-Myers Squib’s Pargluva (muraglitazar) for type II diabetes mellitus; Endocrinologic & Metabolic Drugs Advisory Committee Sept. 8 and 9, respectively.

Genetech/OSI’s Tarceva (erlotinib) supplemental indication for pancreatic cancer and Abbott’s Xinlay (atrasentan) for metastatic hormone-refractory prostate cancer; Oncologic Drugs Advisory Committee Sept. 13.

Celgene’s Revlimid (lenalidomide) for MDS and GlaxoSmithKline’s Arranon (nelarabine) injection for acute lymphoblastic leukemia; Oncologic Drugs Advisory Committee Sept. 14.

That’s five NMEs and a novel protein formulation potentially sanctioned for launch in a single month. Not too shabby.

I guess his coverage in the press has slowed enough to leave his ego insufficiently massaged. Peter Rost, the VP at Pfizer whom I last wrote about in these pages June 8th, is now lambasting his boss (Hank McKinnell, CEO Pfizer) in his Amazon review of McKinnell’s book A Call to Action. After you get a kick out of that one, check out his other reviews too. He calls Marcia Angell’s book on the pharma industry a “masterpiece”. He is obviously insane, poor fellow.

Pharma’s Cutting Edge
Vol. 3 Number 8 - August 2005

Hype or Hope: Eliminating Suffering and Death from Cancer by 2015 2010

I finally got around to reading the National Cancer Institute’s Cancer Bulletin for July 19, 2005 written by NCI Director, Andrew von Eschenbach. Dr. Eschenbach devotes the entirety of the two-page bulletin to his reply to the recent question posed by Sen. Arlen Specter (R, PA): “What would it take to accelerate by 5 years the achievement of the 2015 goal of eliminating the suffering and death due to cancer?” For those of you who were already skeptical of the aggressive 2015 goal that Eschenbach set two years ago–believing it was little more than aggrandizement for the purpose of ensuring continuous generous public support of NCI initiatives for the next decade–what must you be thinking now? Never mind the question. I know exactly what you are thinking now; I am probably in agreement with you.

Let’s cut to the bottom line. If there is any chance to eliminate suffering and death due to cancer by 2010 (less than five years away, remember), it would have to mean eliminating suffering and death among those who either are already diagnosed with cancer and are receiving treatment (or watchful waiting) with approved or experimental therapies or those who have cancer lurking somewhere in the body and don’t know it yet. This is because cancer takes years to become established through the processes of initiation, promotion and progression to malignancy. So strategies aimed at actually preventing cancer, by interrupting its initiation or promotion, for instance, will not play a role by 2010. We’re left with two possible interventions: (1) Diagnostics, to detect and treat cancer earlier, after malignant conversion but prior to widespread metastasis, when the disease associated with longer survival and (2) Agents that have already been approved to treat cancer or those that are in the latter stages of development.

I’m not going to focus on diagnostics, because, well, this IS a pharmaceuticals and biopharmaceuticals newlsetter/blog. But I will point out that diagnostics capable of reliably detecting some of the most deadly cancers before they are clinically apparent or dangerous–Eschenbach mentions ovarian and lung–are still years away from routine clinical practice. Yes, progress is being made, and it’s being made at a rapid pace, spurred on by NCI/FDA initiatives and industry incentives to be first to market. Just this past week, for instance, Mian et al published a promising study of a mass spec-based peptidomic assay that could distinguish early- from late-stage melanoma. In a thoughtful editorial accompanying the Mian study, Robbins et al point out the many technical difficulties that must be overcome before a new cancer diagnostic is ready for routine clinical use. Despite reliable predictions of melanoma stage using 205 serum samples, much further work is needed before Mian et al’s assay could be used routinely. From Robbins et al: ” The proof of the potential value of this exciting new approach will be in the ability of disparate groups to reproduce either the entire proteomic patterns generated in other labs or to show that the highly discriminatory peptides have the same amino acid sequences and, thereby, truly qualify as cancer biomarkers. Welook forward to new reports using this technology and validation studies to assure its authenticity. At present, this promising new approach is not yet ready for patient classification or treatment choices.” Similar sentiments might apply to every peptide-or protein-based novel diagnostic test in development. Read the rest of this entry »

Read this follow-up story from the Seattle Times. Here’s the orginal piece. Also see a recent story from Business Week on the same topic. For the record…I run [Editor’s note:  I ceased this activity entirely soon after this piece ran] a company that is considered one of these “matchmakers,” although we operate on a much smaller level than Gerson Lehrman or some of the others and focus on the industry side rather than the clinical researcher side (in industry, obtaining and revealing competitor information is a sanctioned function known as “competitive intelligence”). Do some investors try to get genuinely inside information from experts? I have no doubt after speaking with many investors and researchers that some do. Analysts and investors are under tremendous pressure to perform, and the best way to perform is to have an undeniable information advantage. That said, I believe that most investors act ethically and avoid asking insiders questions that will compromise their confidentiality agreements with industry sponsors. Clinical investigators must be very circumspect when speaking with investors. Every time I have spoken with a clinical investigator on behalf of an investor, I’ve cautioned her not to reveal any confidential information. Every time. I believe that most clinical researchers do not even realize that they could be considered insiders by the SEC and pay severe penalties for disclosing confidential information to investors. Surely, however, all investigators read their contracts and understand that they must not breach sponsor confidentiality. Sponsors should do more to remind investigators of their obligations; usually they do nothing more than deliver the contract. Investors should never tempt investigators to breach confidentiality. It’s illegal and unethical. Let’s hope that this spotlight on the “big boys” of expert access will end the improper behavior.