Comparative Effectiveness Research--Blessing or Curse for Life Sciences Industry?

We welcome a new author to our blog, Dr. Joel Studebaker who discusses an issue that is certain to have an impact on the entire Life Sciences Industry assuming the Obama administration is able to get this legislation passed. Joel's biography is appended the end of this article.

Comparative Effectiveness Research:

The $1.1 billion in funding for comparative effectiveness research (CER) in the federal stimulus plan has considerable significance for the pharmaceutical and medical device industries. This funding will support studies of the effectiveness of alternative therapies – pharmaceutical, device, or medical procedure – for particular medical conditions. The studies will focus on outcomes like improvements in patient status or adverse effects but they will not currently consider the costs of treatment. Proponents of CER assert that it provides opportunities to control health care costs without sacrificing quality and to give physicians systematic, unbiased data about outcomes for competing therapies. Opponents believe the results will determine which therapies receive reimbursement from government and private insurance and thus effectively dictate medical decisions to physicians. In addition, there is concern that CER studies may lead to studies that do consider cost, with the result that treatments that are effective but relatively expensive will not qualify for reimbursement. In the United Kingdom, the effectiveness studies of the National Institute for Health (NIH) and Clinical Excellence (NICE) currently take cost into account.

Clinical trials represent the most rigorous approach to CER, and pharmaceutical companies sometimes publish the results of trials demonstrating that their products produce better outcomes than competing alternatives. The expense of clinical trials limits the number of patients they can include and the length of time they can cover, however. A second approach is to compare the reported results of clinical trials of products aimed at the same clinical condition. The major challenges in this approach are that different studies may use different methods and significantly different patient populations. A third approach is to analyze data available in medical and pharmacy claims. The data in medical claims submitted to insurers, managed care organizations, and government programs includes codes identifying the patient’s diagnoses, the procedures carried out, and the provider for each claim. Pharmacy claims submitted to pharmacy benefit managers provide data on drugs a patient is taking. Some private plans and government programs cover millions of members, and thus they have data on larger populations than a clinical trial can enroll. When membership in these programs is relatively stable over time, it’s possible to study long term effects. Large populations also make it possible to study sub-populations, preserving a measure of personalized medicine in CER.



Referring to studies based on claim records, a 2007 paper from the Congressional Budget Office noted that “A central difficulty in such studies, however, is accounting for the differences in patients’ health status that play a role in determining which treatment they get… Insurance claims typically do not include any information about health status.” To overcome this difficulty, one may use a software package that classifies individuals by health status on the basis of their claims. One should recognize, however, that there are limitations to using claims for CER. Unlike a clinical trial, a study of claim data lacks demographic data beyond age and gender, results from laboratory tests (though diagnoses may reflect laboratory results), or medical charts. Precedents for using claim data in comparative research include a Lilly study of cost effectiveness for the antipsychotic olanzapine and a Pfizer study comparing patients taking Lipitor® to patients taking Merck’s Zocor.



Currently, it’s not clear what new insights future CER activity will produce or what impact they will have on health care. It is possible that a body similar to NICE will come into existence in the US or that the FDA will begin to consider CER comparing products submitted for approval to products already on the market. One observer has suggested that CER results may eventually be the only way for a particular product to succeed in the marketplace in competition with less expensive alternatives.



Dr. Joel Studebaker's – Biography



After finishing graduate school, Joel Studebaker began his career at the IBM Watson Research Center in Yorktown Heights, NY. He then moved to IBM Biomedical Systems, a small division that made centrifuges for separating blood into components, where he established the laboratory for chemistry and hematology. After IBM sold that division, he worked on an IBM project at Princeton University for three years and then worked with Larry Rothman at the IBM Engineering/Scientific support center and the Pharmaceutical Industry Center.



Since leaving IBM in 1992, he has worked as a developer and project manager in databases and software development for several small systems integration firms. His pharmaceutical/biotech experience has included two tours of duty with the American Red Cross Blood Banks, an assignment managing the discovery software support group at J&J PRD in Raritan, NJ, and a position as Associate Director of Informatics at Orchid BioSciences. More recently, he has worked in medical and pharmacy claim analysis at CareAdvantage and Integr-eCare.



His current interests include comparative effectiveness research and single nucleotide polymorphisms in personalized medicine. He holds a BS in chemistry from Stanford and a PhD in chemical physics from Harvard.

Pharmaceutical Industry Consolidation-And the Winner is Pfizer, Merck or Roche????

And the Winner is Pfizer, Merck or Roche????

We promised our view on the potential results of the 3 "super-mega-global-mergers" that have taken place in the last 60 days and we don't wish to disappoint. As we don't want to keep you in suspense, we think that Roche is getting the most “bang for the buck”, BUT it is highly dependent on the non-integration of Genentech.

Let's start with the contenders-first Pfizer-Wyeth. No surprise here, we think PFE vastly overpaid to get a potpourri of businesses with a dog's breakfast of vaccines, biotechs, consumers and some underwhelming pipeline potential. It seems to us that the major drive here is “synergy”, that is reducing workforce size by nearly 20,000 while plugging some of the $11-13 billion hole that Lipitor going off patent in 2011 creates. The stock market has not exactly been “irrationally exuberant” about Pfizer's 10 year $258 billion spending spree for Warner Lambert, Pharmacia and now Wyeth and has inversely rewarded share holders with a nearly 70% reduction in market capitalization from the day of the Warner Lambert deal close (Pfizer's market cap about $300 billion) to this week's $95 billion. Need we say more?

Merck strikes as a version of more of the same. Paying a 30%+ premium (about $41 billion) to combine 2 feeble pipelines and some redundancy (maybe another 20,000 people reduced), "diverse" and/or non-intersecting cultures doesn't strike us as “happy days are here again”. In fact while Pfizer-Wyeth pretends to be a “diversification” play as opposed to a "consolidation", Merck-ScheringPlough doesn't even try to excuse itself with such rhetoric. There is Dick Clark's (Merck's CEO) trying to convince us that Schering Plough is somewhat of an international powerhouse (try telling that to executives of any of Europe's Big 3 pharmaceutical houses), and that Remicade will drive sales of several billion more-can you spell J&J? The reverse acquisition route seems spurious at best-we're no lawyers but can't imagine the transparency of this shenanigan and how it may play with the legal eagles of J&J in New Brunswick. Can we forget about potential in fighting between Fred Hassan (Schering's CEO) and the aforementioned Mr. Clark?

So, back to Roche-Genentech. Sure $95 a share is rich and many a scientist in South San Francisco is going to feel more like a Microsoft Millionaire from the 1980's and therein may lie Roche's opportunity and challenge. Genentech's pipeline is deep and rich with well over two dozen promising candidates and more to come. Much of this has been attributed and rightly so to a combination of brilliant scientists and a laissez faire culture with heralded beer blasts, parties and freedom to explore favorite projects, some of which have become major drugs. The trick is whether Roche's CEO, Franz Humer and his merry band from Basel can convince Art Levinson and Genentech's San Francisco based minions that it's business as usual and that things can only get better from here. We're going to guess that while this is a classic consolidation play, the boys of Basel will do it right.

As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.


Contributed by Larry Rothman

The Pfizer-Wyeth Merger - We Were Wrong – They are WRONGER

OK, I was wrong, but there is no mea culpa needed. The Pfizer (NYSE: PFE) and Wyeth (NYSE: WFE) deal has been announced and somehow financing was arranged. The hubbub in the media seems to support my opinion that this a bad deal for Pfizer’s shareholders, especially if you’re one of the 19,000+ employees who will likely lose their job in this deal. (Wanna bet that after President Obama gets through bashing banks for paying out $18 billion in TARP funds for bonuses, he’ll be setting his sights on Big Pharma.) Although, Jeff Kindler may still be trying to put a positive spin on things. Jeff better be good at spin meistering with a 50% reduction in Pfizer’s dividend-anyone notice that after an initial run up, both PFE and WYE retreated rather significantly based on some on Wall Street who don't view this merger as a layup after all.

Mike Huckman’s been busy doing the post-game review on this deal. Check out his blog (http://www.cnbc.com/id/15837675 ), in particular, his January 27th and 28th blogs. He offers some interesting perspectives and also links to a Wall Street Journal analysis of the deal. Other than the companies themselves and their hired flacks, I haven’t come across any serious commentators who think that this is a good deal.

I’m going to keep sticking my neck out on this one though. The virulent press reaction and Kindler’s ability to keep the financing together for this deal are my two main reasons.

First, the press reaction. Pfizer is simply buying revenue (at a very high price we add) to offset its looming loss of Lipitor to the generics. Kindler’s been trying to keep his job and has been shuffling assets around in a corporate finance version of three card monte. More people are going to be looking at this deal and start questioning it. I don’t expect anyone to be riding to the rescue with a counteroffer. Anybody remember Boston Scientific (NYSE: BSX) and Guidant? Let’s see, how many billions in overvalued assets did Boston write off the other day? Many pundits (and we agree) think that Pfizer would have been far better off buying several biotechnology companies (e.g., Biogen-Idec, Gilead, Genzyme or as we have advocated Amgen all would have helped) and why justify re-entering the Consumer business when two years ago, Kindler and company claimed they were selling the Pfizer Consumer business to J&J (NYSE: JNJ) so they could "focus' on Pharmaceuticals.

Next, let’s talk about that bank financing. I haven’t come across any details about which financial institutions or investors are behind the $22.5 billion in external financing or its terms. In these times of credit crisis, I’m sure that they are very interesting. By the way, another $47.5 billion will come from internal financing. One commentator noted that Pfizer would probably have to repatriate offshore cash to help with the deal. I suspect that this could mean paying US corporate taxes. Again, not a great deal for shareholders. Given the lack of value that deal produces along with the job losses noted above, I wonder if banks might start rethinking their loan arrangements. Sooner or later, Washington, DC is going to start asking what’s happening with all the money being forked over to the financial services sector. Executive bonuses and job losses don’t seem like a good return for taxpayers’ money. Somebody’s going to start paying attention here.

As always, we welcome your feedback. Please contact us at larryrothmansblog@gmail.com. We look forward to hearing from you.

Contributed by Guy de Lastin

Pfizer-Wyeth-Are We Kidding? If Not, Who and What is Next??

A Pfizer Wyeth Merger—Are We Kidding? If not, Who's Next??

This morning, January 23rd, The Wall Street Journal “speculates” that there have been talks between Pfizer and Wyeth about a combined company, although they quickly point out that there is nothing imminent. My colleague Guy de Lastin recently wrote in this blog that there isn't a rational business reason for big pharmaceutical company mergers this year and has been notably supported in The Journal with "The record of big mergers and acquisitions in big pharma has just not been good. There's just been an enormous amount of shareholder wealth destroyed," said Gary Pisano, a Harvard Business School professor who has written about the issue.

Admittedly there are contravening forces at play here-Pfizer among others has been notably non-productive in its R&D sector spending over $7.5 billion a year with little tangible payoff—in fact they announced 800+ layoffs for this particular group in the last week or so. On the other hand, Wyeth has had a bit more success with a newly re-engineered R&D organization—having said that, both companies have major blockbusters, Lipitor and Enbrel come from acquisitions, not in house development. Clearly there are enormous “synergy targets” should two such massive businesses merge. Combine these factors with an investment community that is pushing for consolidation, and a lower market cap this year than last mixed together with a cash position of over $25 billion for Pfizer and a market capitalization of just over $50 billion for Wyeth—maybe, just maybe this could happen.

If Pfizer-Wyeth becomes a reality, we enter a new realm of what we call “Super-Mega-Global” Pharmaceutical giants. This may force other merely mega-globals into a merger frenzy. Europe's big 3, Glaxo, Novartis and Sanofi may view the world in a different way and look in their backyards at the likes of AstraZeneca, Bayer and even Roche as feeding fodder. How about the likes of Merck, J&J, Abbott or BristolMyers looking over the landscape at each other or such potentially delectable morsels as Amgen, ScheringPlough or others or each other or some large generics, or...... You get the point, in an industry known for follow-the-leader mentality, the investment bankers, lawyers and our friends the consultants are in for some major paydays.



Contributed by Larry Rothman