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Marching Band Changing Guard LondonToday marks a year since we put up a paywall on Biotech Strategy Blog. While we were sorry to have to restrict access in this way, our decision reflects what is happening in the wider digital media arena, it’s simply not possible to go to conferences and generate quality content for free!

It was Warren Buffett who said, “Price is what you pay, value is what you get” and that’s how we feel about charging for access to Premium Content on the blog.

When we put a paywall up on the blog last September, many thought it would not last. All those who bet on its early demise are still waiting 😉

What the paywall has done is create an exclusive club that have access to our insights and analysis. Other traditional media organizations are now following suit, by charging a membership fee for premium access.

There is a wealth of free data on the Internet, and lots of media folk do a good job of sharing or curating this, but raw data is not intelligence, nor do they tell you anything about context or meaning. Insights also require knowledge, expertise and thought to generate.

Journalism and digital media are going through a revolution as those who create original content seek to get paid for it. We are part of that vanguard. So this post is a big thank you for all our subscribers from around the world who have supported our initiative.

Our thanks also to Tinypass, who as our technology partner, creates the paywall and administers the payment processing system. We could not have achieved the success we have had without them.

Year in Review:

Looking back at this year, we’ve covered remotely or on site 10 conferences or scientific meetings:

  • ECCO 2013 (Amsterdam)
  • AACR-EORTC-NCI Molecular Targets (Boston)
  • World Lung (Sydney)
  • ASH 2013 (New Orleans)
  • SABCS (San Antonio)
  • JPM 2014 (San Francisco)
  • ASCO GI (San Franciscso)
  • ASCO GU (San Francisco)
  • Miami Breast
  • AACR 2014 (San Diego)
  • AUA 2014 (Orlando)
  • ASCO 2014 (Chicago)

Funding from our subscribers enabled us to attend most of these meetings in person. In addition we’ve followed interesting new stories e.g. by going to Paris to interview the senior management of Cellectis about their CAR-T cell therapy.

By my calculation we’ve written approximately 120 premium content posts of the past year, so the cost per post at the current annual rate is about $10. Those who signed up for special offers got them for even less.

So thanks to everyone who has supported us over the past year, we greatly appreciate you being part of the journey with us. We look forward to welcoming new subscribers over the coming year.

For a limited time only (until end of October) we are offering a special anniversary offer where you can lock in your rate for 2 years. Just click on any post and scroll down to sign up in the box under the post.

Check it out!

 

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A survey of patients who had their prostate removed showed there was no significant difference in complication rates between open retropubic radical prostatectomy (ORRP) and robotic assisted laparoscopic surgery (RALRP).

This is an important finding because 85% of prostatectomies in the United States are undertaken using robotic-assisted techniques, yet there has been little published data to show that this technique improves functional outcomes.

At the European Association of Urology (EAU) annual congress last year in Vienna some of the challenges and opportunies with robotic surgery were raised:

  • lack of data on improved functional outcome
  • need for licensing of robotic surgeons
  • high learning curve – it takes 250 patients to become proficient

In reality, we see hospitals marketing their robotic surgery to patients in shopping malls and with advertisements on the side of buses.  You can read Gary Schwitzer’s thoughts on some of the recent marketing claims & “gizmo idolatry.”

This is why a survey comparing the results of open to robotic assisted prostate removal surgery is important evidence based medicine. Published online first in the Journal of Clinical Oncology, Barry and colleagues randomly surveyed 800 men who filed Medicare claims between August and December 2008.  685 completed surveys were returned, and information on adverse events was obtained.

The data highlights the dramatic effect on quality of life that prostate cancer surgery can have, irrespective of the surgical technique. The men rated themselves:

31.1% – moderate or big problem with continence  (95% CI 27.5 to 34.8%)

88.0% – moderate or big problem with sexual function (95% CI 85.4% to 90.6%)

Breaking this down by technique (robotic surgery versus open prostatectomy):

Continence: 27.1% of men (Open) versus 33.3% (Robotic) – not significant (P=0.113)

Sexual Function: 89.0% of men (Open) versus 87.5% (Robotic) – not significant (P=0.57)

The authors conclude in their JCO paper:

Our results do not demonstrate a lower risk of problems with incontinence or sexual function after RALRP compared with ORRP.

In fact, after adjusting for potential confounders, there was at least a strong trend toward a higher risk of patient-reported moderate or big problems with incontinence following RALRP.

The authors in their discussion do raise the interesting question as to whether patients were led to believe that they would have fewer side effects with robotic surgery, which may have impacted the survey findings.  This merits further investigation.

There is clearly a need for patients to give informed consent, and be aware of the risks and complications of prostate cancer surgery, particularly with regards fundamental quality of life issues such as continence or sexual function.

The accompanying JCO editorial by Matthew Cooperberg and colleagues from UCSF is well worth reading and raises the question as to whether men with prostate cancer should expect better outcomes than those reported in the survey?

What the survey by Barry et al did not do is look at the volume of procedures and experience level of the surgeon, both of which are associated with outcomes.

Cooperberg noted that “surgeons performing fewer than 5 prostatectomies per year account for approximately half the national volume.

A chilling statistic, and if you factor in the learning curve of more than 200 procedures to be competent at robotic surgery, it is perhaps not surprising that some men experience higher complication rates than others.

Which brings me back to the importance of the PIVOT (Prostate Cancer Intervention versus Observation Trial) data presented in the plenary session at the 2011 annual meeting of the American Urological Association (AUA) in May last year.

Why has this practice changing data not been published in a peer-reviewed journal yet?

The fact that the updated PIVOT study results presented at AUA 2011 have not been published (to the best of my knowledge) is a disservice not only to the medical and scientific community, but to men with prostate cancer whose treatment should be guided by evidence-based medicine.

The long-term results of the PIVOT trial presented by Professor Wilt showed no benefit of radical prostatectomy over watchful waiting, except for high-risk patients.  Yet, the reality is that many men end up having surgery. This may be considered overtreatment and an exposure of more men than is necessary to the complications of prostatectomy, irrespective of whether this is robotic or open surgery.

The decision to undergo radical prostatectomy should be an informed one, not only as to the risks and benefits of the surgical technique, but also whether the surgery should be performed in the first place as compared to “watchful waiting.”

I hope the paper and editorial published in the JCO this month will generate some debate. Next month I will be at the European Urology Association annual congress in Paris.

References

ResearchBlogging.orgBarry, M., Gallagher, P., Skinner, J., & Fowler, F. (2012). Adverse Effects of Robotic-Assisted Laparoscopic Versus Open Retropubic Radical Prostatectomy Among a Nationwide Random Sample of Medicare-Age Men Journal of Clinical Oncology DOI: 10.1200/JCO.2011.36.8621

Cooperberg, M., Odisho, A., & Carroll, P. (2012). Outcomes for Radical Prostatectomy: Is It the Singer, the Song, or Both? Journal of Clinical Oncology DOI: 10.1200/JCO.2011.38.9593

Update August 12, 2012 – Paper published in European Urology shows lower incontinence and greater rate of erection recovery with robot-assisted radical prostatectomy

A paper published online (July 20, 2012) in the journal, European Urology by Franceso Porpiglia provides some evidence that robot-assisted radical prostatectomy offers functional benefits to patients. I have not read the full paper only the freely available abstract.

The clinical trial evaluated the functional outcomes of 120 men in a randomized clinical trial where half (n=60) received radical prostatectomy (RARP) that was robot-assisted and the other half (n=60) who had the operation laparoscopically without robot assistance (LRP).

Following the surgery performed by Dr Porpiglia, the functional outcomes between the two groups were compared. Those men operated on with robot assistance showed:

  • Lower incontinence. “Continence after 3 mo was 80% in the RARP group and 61.6% in the LRP group (p = 0.044), and after 1 yr, the continence rate was 95.0% and 83.3%, respectively (p = 0.042)”
  • Better erection recovery. “Among preoperative potent patients treated with nerve-sparing techniques, the rate of erection recovery was 80.0% and 54.2%, respectively (p = 0.020).”

The challenge of this study is that although it was randomized, it reflects the results of only one surgeon with a small number of patients.

Dr Matthew Cooperberg (@cooperberg_ucsf) was quoted by Reuters saying that this was likely the best study we were going to get showing the benefits of RARP over LRP. On twitter he said the real question was now between radical prostatectomy and external radiation therapy (XRT).

https://twitter.com/cooperberg_ucsf/status/233427660708126721

For those readers who would like to access Biotech Strategy Blog on their Kindle, this is a quick post to let you know it is now available on the Amazon Kindle Store for $0.99/month.  You can also continue to read it for free on the web.

Biotech-Strategy-Blog-Amazon-Kindle-StoreOf course, after Amazon takes its cut there is a (very) small royalty fee that ends up coming my way, so I have vested self-interest in promoting this.  However, it’s not something I anticipate getting rich from!

In a world of multi-channel marketing, it is good to try out new ideas that may make it easier for people to access content and information.

Radium-223 (Alpharadin) is a novel bone targeted treatment for advanced prostate cancer.

At the recent European Multidisciplinary Cancer Congress in Stockholm (EMCC 2011), Dr Chris Parker from The Royal Marsden Hospital presented results of the phase 3 ALSYMPCA trial that showed both delayed time to first skeletal-related event (SRE) AND an overall survival (OS) benefit for those men with advanced prostate cancer taking radium-223.  This is the first time a product in the bone category has shown such a survival benefit – neither denosumab or zoledronic acid can claim that distinction.

Unlike the recent regulatory approvals for cabazitaxel (Jevtana) and abiraterone acetate (Zytiga), which focused on the post-docetaxel setting, the ALSYMPCA trial included not only those who had already received cytotoxic therapy, but also pre-docetaxel patients, who were unable to take chemotherapy.

As Dr Parker mentions in the interview that he kindly gave in Stockholm (the first video interview on Biotech Strategy Blog), radium-223, assuming it gains regulatory approval, will provide a new treatment option for the considerable population of men with bone metastases who may be too weak, too old or otherwise unable to take chemotherapy such as docetaxel.

Radium-223 is, therefore, potentially good news for this “neglected” population of prostate cancer patients.

In the video interview, Dr Parker talks about why he believes combining radium-223 with abiraterone acetate (Zytiga) makes sense.

He also talks about some of the challenges that radium-223 still faces, such as how to monitor treatment and work out the optimal dose.  It is hard to believe that Algeta/Bayer would undertake a phase 3 registration study of a novel bone targeted agent without any bone imaging in the protocol!

As Cora Sternberg mentioned in the educational session at EMCC 2011, in advanced prostate cancer, “80% of the disease is in the bone.radium-223 is an exciting radiopharmaceutical that is likely to be “practice changing” once approved.

That’s not to say there are not going to be challenges and issues with its commercialization.  Algeta/Bayer have a lot of work to do now that it is clearly on fast track for FDA approval next year.

Dr Parker also mentions in his interview that radium-223 is a weak alpha emitter and the radiation can be blocked by paper or glass. It therefore requires no special facilities, such as lead lined rooms, for its administration, unlike beta emitters.  The latter have been challenging commercially in the past for this reason.

However, it does require a radiopharmaceutical license, which means that community based oncologists and urologists in the United States will most likely have to refer patients to receive their injection at an approved facility where there is a nuclear medicine/radiology department or equivalent expertise.  In Europe, this is less of an issue given most cancer patients are treated in outpatient clinics associated with hospitals, whereas in the US, the majority of patients are seen in the community setting.

Despite that, it is hard to believe that radium-223 (Alpharadin) will not have a major impact on the advanced prostate cancer market if it can be commercially supplied without difficulty and the details are worked out on how to use it optimally and monitor progress. I am sure we will hear more on these issues at cancer conferences next year.

Looking at the other indications for bone targeted agents such as denosumab and zoledronic acid, radium-223 or a similar radiopharmaceutical could offer potential benefits in other tumor types such as breast cancer, were there are also skeletal related events (SRE’s) associated with treatment.

The video interview I did with Dr Chris Parker is well worth watching, and I am grateful to him for taking the time out of his busy schedule at the recent Cancer Congress in Stockholm. Since this is a first for Biotech Strategy Blog, do let me know if this is something you’d like to see more of moving forwards.

Challenges & opportunities for radium-223 (Alpharadin) in advanced prostate cancer – an interview with Dr Chris Parker 

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The patient advocacy session on “Cancer and the Internet” at the 2011 European Multidisciplinary cancer congress (#EMCC2011) in Stockholm was well attended by patient advocates from across Europe, as well as industry and communications professionals.

The session focused on building online communities, how the internet can help patients with rare diseases have a voice with policy makers and showcased the new European cancer portal: ecancerHub.

Chaired by CML advocate, Jan Geissler (@jangeissler) the session heard from ACOR founder Gilles Frydman (@gfry), Denis Costello from Eurodis (@rarecare) and Richard Sullivan from Kings College London.

Earlier this year, the PEW Internet & American Life Project reported that 80% of internet users have looked for online health information around a disease or major health topic. The internet continues to grow in its importance to patients and how the pharmaceutical/biotechnology industry reaches them.

One of the challenges expressed in questions from the audience was the plethora of information available on the internet to patients, and how the number of available sites continues to grow, leading to overwhelm.  Knowledge, as Gilles Frydman wryly observed, is always in beta.

ecancerHub is a new online global cancer community and knowledge portal

Superportals such as the ecancerHub are likely to play an increasing role in how patients share information and research the internet, especially if they can curate reliable, accurate and independent sources of information.

Funded by the European Commission’s eurocancercoms project, ecancerHub aims to become a leading knowledge base for cancer information and also where online communities of patients can easily meet to share experiences and learn from each other.

Other than a quick visit, I have not yet had the chance to check the site out fully, but it looks promising. I was particularly interested by the future developments that were discussed, such as focused search engines that will help people find clinical trial or cancer information.

Ultimately, ecancerHub will only succeed if it gains a critical mass of users and to do this, not only must it become widely known, but it also has to offer superior content, ease of use and an online experience that promotes patients to preferentially build enduring and valuable communities on it as a one stop hub, rather than elsewhere.

If you are a cancer patient or have an interest in healthcare social media, ecancerHub is worth a visit.

Yesterday, it was announced that Google had reached a settlement with the United States Department of Justice and would forfeit $500M in gross revenue received from Canadian online pharmacies advertising to US consumers through the Google AdWords program.

According to the Government, these advertisements then led US consumers to buy and illegally import prescription drugs from Canada.

The settlement with the Department of Justice (DOJ) was in many ways inevitable.  Once the Government decided to go after Google to the extent of submitting fake online ads on behalf of fake online pharmacies, that Google ran and provided customer support to, the question was not if Google would settle, but for how much?

$500 million sounds a lot, but in the context of 2010 revenue of $29.3 billion, it’s only 1.7% of last year’s sales (if my calculations are correct).  It comes across as a slap on the wrist as Google is only required to forfeit to the Government the “illegal” revenue they obtained over the course of several years.

When Google advised investors earlier this year that they had accrued $500M in anticipation of a possible settlement, the company noted (emphasis added):

“Although we cannot predict the ultimate outcome of this matter, we believe it will not have a material adverse effect on our business, consolidated financial position, results of operations or cash flows.

There is no fine or punitive damages. Reaching a settlement to avoid a criminal prosecution makes sound business sense.

In the Google AdWords case, the reality is that many prescription drugs are cheaper in Canada. Many senior citizens living close to the border go to Canada to obtain their drugs. Although open to abuse, there is nothing inherently wrong in consumers wanting to buy the same product cheaper, if they can readily do so. The power of the internet to reach consumers wherever they may be has brought the power of economics and market forces to all of us.

What the Google/DOJ settlement doesn’t do is address the underlying reason why are many prescription drugs more expensive in the United States compared to Canada?  In other words, it shoots the messenger rather than deal with the underlying problem. If prescription drugs were the same price in both countries, this problem simply would not exist – there would be no market for online pharmacies in Canada.

The settlement announced yesterday and all the compliance features included within it will not stop the practice of US consumers looking to Canada for cheaper drugs. It just means that one advertising and marketing channel has been eliminated.

As Sally Church noted recently on Pharma Strategy Blog, the increasing price of new oncology drugs in the United States is unsustainable.

Why should US consumers pay more for drugs than their neighbors in Canada? After all the currencies are similar in value, and I’d argue the countries are comparable in terms of industrialization, wages and society i.e. we are comparing similar countries in terms of economic development. We are not comparing the price of drugs in a developed country to the price in the third world.

As the world’s largest market for pharmaceuticals, why does the US have the highest prices for prescription drugs? The difference is in the health care systems – the US is a free market where the price is what the market will sustain. Drug prices are not regulated, imports from cheaper countries are prohibited, and the payors (insurance companies) are able to pass on the cost of higher drugs direct to the consumer through higher insurance premiums.

In Canada, the Provincial governments are the payors and they regulate and control the price of drugs.  The United States is a great market for pharmaceutical companies (maximum profits) but poor for the consumer who picks up the price of branded prescription drugs whether through high co-pays or higher insurance costs.

As a result the healthcare system in the United States remains fundamentally broken, despite recent attempts at reform, and to me the Google/DOJ settlement is yet another reminder of this.

With the collapse of the Dendreon share price today following poor sales data (Adam Feuerstein on The Street has an excellent write up about this), attention has again focused on the prostate cancer market.

Zytiga (abiraterone acetate) was recently approved by the European Medicines Agency (EMA), following FDA approval earlier this year.

The EMA Committee for Medicinal Products for Human Use granted the marketing authorization for Zytiga at it’s July 2011 meeting.  The approval noted,

“The poor prognosis of the target patient population represents a high unmet medical need while the novel mechanism of action of abiraterone has the potential to offer an alternative therapeutic option for these patients.”

What does this mean for sales of sanofi-aventis’ cabazitaxel (Jevtana), which was approved in Europe earlier this year?

Given that both drugs have approval in the same indication for metastatic castrate resistant prostate cancer (mCRPC) post-docetaxel chemotherapy, and the price is likely to be comparable, my guess would be that Jevtana sales will take a big hit.

After a sick prostate cancer patient has undertaken several cycles of chemotherapy with docetaxel, why would they not want to take an oral pill as opposed to another chemotherapy drug, which does have a less than stellar adverse-event profile.  The answer is they will probably take a chemo-holiday and use Zytiga.

Jevtana simply came to the market too late in Europe, and Zytiga gained accelerated approval.  It’s a reminder that we live in a dynamic pharmaceutical market place, as the news last night from Dendreon has also reminded us.

Although I had to leave BIO 2011 early due to illness, I did shoot some video during the time I was at the meeting, and have now put this together into a short 2 minute video that you can watch below.

This post wraps up my coverage of the 2011 BIO international convention in Washington DC. Next week, I’ll be writing more about innovative science and new products in the pipeline that have caught my attention.

A happy holiday weekend to everyone in North America.

Bevacizumab (Avastin®) should be withdrawn for metastatic breast cancer. That is the unequivocal recommendation of the Oncology Drugs Advisory Committee (ODAC) yesterday.

Despite the passionate patient advocacy in favor of continued approval, withdrawal is the right decision and it is hard to see the FDA overruling ODAC, given the safety issues such as bowel perforations and relative lack of efficacy.  The patient advocacy at this week’s public hearing was fundamentally biased, those who died early and who received no treatment benefit are not alive to stand up and share their experiences.

The bottom line is that Genentech were unable to identify the sub-set of patients who might benefit from the drug.  They simply did not have the data, and the reality is that treating all potential HER2- patients in the hope of finding the few who might respond is not a rational drug development or marketing strategy, especially when those that don’t respond may do worse on the drug.

Personalized medicine requires a thorough understanding of the science and molecular biology of a disease.  Pfizer recently showed an excellent example of this with crizotinib that targets ALK mutations in non small cell lung cancer (NSCLC).

It is disappointing that a scientifically orientated company such as Genentech would continue to try and push Avastin in Breast Cancer when the data is clearly unconvincing to ODAC.   But, if we look at how Genentech approached the Lucentis v Off-label Avastin issue in AMD, with a 40x higher cost for using Lucentis, then what we see is that commercial decisions, and maximization of profit has become more important than doing what’s right for patients.

BIO 2011 Presentation Personalized Medicine Payment Sessions

This is a flawed long-term strategy in my opinion. Society cannot afford to pay for treatments that don’t work in many patients or pay for treatments that are excessively priced. We are already seeing “pay for results” being introduced in Europe, notably England and Italy where payors are reimbursing companies only for those patients that respond.

Personalized medicine is the future. This requires targeted therapies that are aimed at patients who we can predict will have a good chance of responding based on our understanding of mutations, molecular biology and biomarkers.

Avastin in metastatic breast cancer is not an example of personalized medicine and should be withdrawn from the market for this indication.

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