When I first heard the news in my Twitter stream (from @sciam) that Ruth Bader Ginsburg has pancreatic cancer, I immediately thought 'uh-oh'. It's usually a deadly disease because the symptoms are caught late and is one of the most malignant and deadly carcinomas unless caught early. The last year has seen the loss of Randy Pausch and Gene Upshaw to the disease, while Patrick Swayze is still valiantly fighting it and Steve Jobs has a much rarer form of neuroendocrine tumour associated with the islets of langerhans that can be treated with surgery, although it can lead to disruption in metabolism.
The good news is that on my return, I checked the news updates and found that she was attending Memorial Sloan Kettering Cancer for surgery to remove a small 1cm lesion from her pancreas. When caught early, like most carcinomas, pancreatic cancer is curable, so the signs are fortuitious at least. The Wall Street Journal Health Blog has a nice synopsis of the disease and what it means for anyone interested.
Ginsburg previously had chemotherapy and radiotherapy back in 1999 for colon cancer and recovered strongly. It will be an interesting term in the Supreme Court without her as she will likely be out of action for a period. In an increasingly conservative court, she will be much missed. Back in 2007 she vented her frustration with the court's
increasingly right tone by writing two sharp dissents and reading them from the
courtroom.
recently, asking in the wake of the Wyeth-Pfizer news what strategic decisions we would like to see taken. His own take?
"I'd love to see companies:
Admitting that giant R&D is insufficiently productive, and working to leverage Open Source research business models
Basing its future business model around the fact that the U.S.
private healthcare system is going to fold in the next few years, and
thinking up innovative pricing models
Focusing on deep expertise in certain diseases, especially chronic disease
Pioneering new ways to relate to doctors, accepting that the sales rep/advertising model is close to extinct."
All very good points indeed and ones I agree with.
If we look at some of the interesting developments in oncology recently, they have come from Genentech, an independent biotechnology company partly owned by Roche. Small is sometimes better, more nimble and more productive. Except that Roche are now signalling aggressive hostile action to snap up the remaining 44% they don't own.
Over the last few years, Genentech have been busily searching out cool technologies and licensing them from smaller biotechnology companies such they they now have an interesting pipeline that makes many big pharma companies green with envy. Some of them will be long shots, some might make it through to market and make a difference, but the important thing is thinking big picture for the long run.
I'd like to see more pharma companies look at their pipelines and think about stocking up on licensing some of these technologies and products as opposed to the traditional approach of dinosaur mergers, which are often great for the short rather than the long term.
What else might be a positive step forward?
Greater involvement in health and medical education
Rekindling sponsorship in basic research and science, which leads to greater innovation and better, more targeted therapies
Reducing bureaucracy; as companies get bigger systems and procedures often grind creativity and innovation to a halt
Smaller, more nimble business units with greater integration from bench to bedside. Scientists, clinicians and marketers can all learn together and work as fully functioning team rather than being bogged down in silo and turf protection mentality
Less 'me-toos' and more risk taking
A sharper focus on strategy and not size for the sake of it
What I see is a dearth of innovation, both in drug development but also the science and technology driving it.
Meanwhile, the innovative pricing models that Eric mentions are already happening now, as seen by companies such as Genentech, Celgene and Pfizer in their approach to the UK's NICE pricing negotiations (see yesterday's blog post). We have yet to see the US move to a more price sensitive market, but the European countries are already leading the way in this area, with a strong focus on demonstrating pharmacoeconomic and quality of life benefit.
As big pharma moves towards less competition and greater consolidation (viz Pfizer, Roche, Merck and sanofi-aventis to name a few), the medium sized pharma and biotechnology companies are taking a more focused approach and looking for biotechnology companies to replenish their pipelines. With the economy tanking, they should gets good deals and hopefully, some blockbusters for the future.
Sometimes though, the world is not enough, as James Bond found. When everyone zigs, it might be more successful to zag rather than follow the herd.
"The company has received a preliminary positive recommendation from NICE for the use of REVLIMID in the NHS in England and Wales. The recommendation specifies the use of REVLIMID, in combination with dexamethasone, as an option for the treatment of patients with multiple myeloma who have received two or more prior therapies."
What was interesting about the decision was that a deal was clearly reached after the initial rejection last August, when the agency baulked at the £4,400/month price tag. Revlimid is an oral therapy normally taken for 26 treatment cycles of 28 days per cycle, giving a two year regimen.
Under the terms of the pricing arrangement with the company, the NHS will pay for treatment with Revlimid for the first two years in patients who have received at least one prior therapy, but should treatment be required after this time then Celgene will cover any costs for patients who continue to benefit, thereby reducing the financial burden on the health service.
This approach is very similar to that taken with Genentech last year.
NICE also reversed an earlier decision not to fund targeted therapy for renal cell cancer when it announced that Pfizer's Sutent is considered cost-effective as a first-line treatment, after taking into account the added value society puts on treatments that extend life at the end of life, in addition to Pfizer's proposal to provide the first cycle of the drug free to the NHS. The average daily cost of sunitinib is £74.74, with an average six-week cycle costing £3,139 per patient.
Those patients who fail Sutent first line therapy, however, will have no other options since NICE rejected Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth) as first-line treatments, as well as Sutent and Nexavar as second-line treatments. In the light of the EMEA's forthcoming review of Novartis's Afinitor (everolimus), it will be interesting to see how they handle that product since the trials were performed in patients who had failed either Sutent or Nexavar.
Rather than limiting the choice of drugs, my own view is that it might make more sense to approve several, since there is little difference between them in efficacy, and find a way to encourage discounting between the companies to encourage uptake. Competitive tenders are another approach which encourage price negotiation in a free market economy. Paying full price for a limited selection of products makes little sense from afar.
It's interesting how different cultures and systems manage limited resources and budgets. In the US, for example, the costs are borne by the Insurers, Companies, Governments and patients. While there is a greater choice, this being the free market, patients increasingly make choices on their prescription co-pay costs.
The more socialised health care systems in Europe rely on the Nationalised health service budgets to be managed by the Government based on national insurance contributions to the kitty. In the system, resources and hence choices, are much more limited but few patients are required to take out a second mortgage to extend the life of a family member by a few months.
In other areas of the world such as China, India and Africa, the UN and WHO have a greater role to play in access to medicines especially for the indigent or the patient pays if they are ineligible for manufacturer patient assistance programs.
Caveat emptor. There is no perfect system; each country can only offer patients the best it can within the constraints and limited resources it has.
“There are no secrets, only information you don’t yet have.”
Drop.io blog
Sometimes random thoughts on the internet can stimulate us in most unexpected ways, as this quote did with me today. In many ways, the statement is very true, at least as far as pharma competitive intelligence (CI) is concerned. Much of the information about products and companies is already out there, hidden in the huge mass that is the world wide web. Often, it is just a matter of superior search skills to ferret out crucial information or key people who may have access to the data you need.
Four things then become critical:
1. An in depth knowledge of the subject area in order to process what is important and what is not. 2. A logical and creative mind to find the information in the first place. 3. A relevant and useful network of contacts. 4. An ability to process both linear and non-linear data into valid patterns and trends as a commentary.
Is it an art or a science?
In the final analysis, like marketing, CI is a bit of both and one should never misunderestimate the power of intuition and gut feel. They sometimes make more sense than logic.
To me, it doesn’t matter if you use cool modern web tools or traditional methods as long as the data gathered is relevant and appropriate. Sometimes a mix of the two works well in tandem, sometimes one or the other is more useful.
However, there is nothing worse than getting a huge ‘book’ or summary sheets of data upon data and no analysis or interpretation. That’s NOT what CI is or should be, it’s undisciplined and inexperienced data gathering, much like imitation and processed cheese is very different from a crafted artisanal cheese. The old chestnut of quality over quantity still applies to CI to this day.
This morning I was searching my Google Reader for a missing article on genetics and advanced prostate cancer when I came across this interesting article entitled, "Masturbation and Prostate Cancer Risk", which was a bit of an eye opener on a Monday morning to say the least. The opening paragraph boldly declared:
"Frequent masturbation in young men is linked to higher risk of early prostate cancer, but it lowers prostate cancer risk for men in their 50s, a study shows."
WebMD reported that the author of the paper, published in the Brit J of Urology, told them that:
"Frequent masturbation during men's 20s and 30s increased their risk of
prostate cancer, but men in their 50s who
masturbated frequently had decreased risk."
Different results like this always leave me suspicious of meta data manipulation. Thinking this was a large scale longitudinal study of 800 odd men, I was disappointed to discover they merely used questionnaires and apportioned risk. Well, that's a poorly controlled study and it's anyone's guess what the real risk actually is. Random associations and spurious findings are highly likely with this approach, especially given that different studies using different methodologies have elicited different results.
My conclusion? An amusing, but likely spurious finding, unless a longitudinal epidemiology study can verify what, if anything, is really happening.
As for genetics, well I'm still looking for that particular paper…
Sources:
Sources: Polyxeni Dimitropoulou, Artitaya Lophatananon, Douglas Easton, Richard Pocock, David P. Dearnaley, Michelle Guy, Steven Edwards, Lynne O’Brien, Amanda Hall, Rosemary Wilkinson, Rosalind Eeles, Kenneth R. Muir (2009). Sexual activity and prostate cancer risk in men diagnosed at a younger age BJU International, 103 (2), 178-185 DOI: 10.1111/j.1464-410X.2008.08030.x
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