Our lives are filled with the shadows of stories unwritten. Our lives are filled with waiting and hoping and putting off and stuffing the cracks with papers from other people’s lives.

If you KNEW without a doubt that your decisions were the measure of who you are – and make no doubt that they are – are you PROUD of your decisions? Are you living the story you want to live?

And what will you do with tomorrow that you haven’t done with today? What lighthouse will you point yourself towards? And what flag will you fly?

Live now. Don’t wait. And fill in some of those shadows with stories you’d want to see written about you.

Chris Brogan's guest post on @julien's blog today really made me stop, think and wonder.

How many of you are out there waiting for something to happen?

Think of the drug pipelines to move, the new indications to drive... Are you moving them forward purposefully or sitting back in the dog days of summer?

This is our busiest time of the year, when catching a moment to take a breather and reflect is harder, but judging by our clients some folk are out there pushing things along and trying to make a difference to the lives of people with various diseases.

Carpe Diem.

There is a lot going on in the world of Pharmaceuticals.  Drugs are being discovered, being marketed, and, far too often it seems, being recalled.

How much will a new medication sell?  Will it make through the clinical trials without being thrown out for lack of efficacy, toxicity, or other issues?

Well, I had a nice surprise this morning - it seems that Pharma Strategy Blog is #7 out of the top Pharma Analysis blogs. The leaders are Ed Silverman's Pharmalot, Jack Friday's Pharma Gossip and Derek Lowe's In the Pipeline.

I was delighted and honoured to even be in a list with such company, but was most amused to see that a sex change appears to have occurred in the process :-).

Astellas announced Monday that it has made an unsolicited offer to acquire all outstanding shares of OSI Pharmaceuticals in a deal worth $3.5 billion. The Japanese company's CEO Masafumi Nogimori said that the "offer follows attempts over the past 13 months to engage OSI in meaningful discussions," adding that "as recently as February 12" OSI rejected an offer from Astellas, saying it "very significantly undervalues" the company.

Whoa! Interesting news to start the month of March in Pharmaland.

On Astellas' website, the press release further stated that:

"The all-cash offer, set forth in Astellas’ letter to OSI delivered this morning, represents a significant premium of over 40% on the closing price of OSI’s common stock of $37.02 per share on February 26, 2010, a 53% premium to its three-month average of $34.01 per share, and a 31% premium to its 52-week high of $39.66 per share. Astellas’ offer is not subject to any financing conditions."

Source: Astellas US

My guess is that the bid will be turned down again and a higher bid will need to be made.

Astellas is clearly keen to expand beyond their urology and immunology focus and build its oncology franchise. It has already completed a deal with Medivation to develop MDV3100 in prostate cancer, so OSI's Tarceva franchise and an interesting pipeline would be attractive to Astellas.

Beyond an improved offer, who knows what will happen. There are no guarantees as the previous offer for CV Therapeutics fell through. It could get very interesting in the next few weeks.

With Medicare reimbursement rates to physicians set to drop by more than 20 percent Monday, Vicksburg physician Randy Easterling, president of the Mississippi State Medical Association, is warning that elderly patients could find themselves with no doctor able to afford to treat them.

Easterling said the 21.2 percent decrease in Medicare reimbursements to doctors will automatically go into effect Monday unless Congress votes to stop it.

“They didn’t vote to stop it last night (Thursday night),” Easterling said Friday. “Maybe they’ll do it this weekend, but if they don’t, doctors won’t be able to see these patients.”

The U.S. House passed H.R. 4691, a “Temporary Extension Act,” Thursday, postponing the reimbursement cuts until the end of the month, but the measure, tied to other legislation, did not pass in the Senate. The Senate adjourned just before noon Friday and wasn’t expected to reconvene until Monday afternoon, according to a floor schedule on the Senate’s Web page. The site indicated no votes had been cast.

A domino-effect could also impact the state’s low-income patients on Medicaid, because Mississippi Medicaid reimbursement is a percentage of Medicare, Easterling said. If one goes down, so does the other.

 

 

 

Impact of Medicare reductions:

In the past, AMA surveys have shown that the threat of reducing the reimbursement for Medicare can have several impacts:

• Physicians have seen their profits from treating Medicare patients fall to just covering their costs, and in some cases where treatment or required tests are expensive, it would mean treating those patients at a loss.

• Some physicians have limited the number of Medicare patients they would be willing to treat and this may increase.

• Other physicians stopped taking Medicare patients altogether and referred them to other doctors or clinics able to take them. This too, may also increase unless the reimbursement system is fixed rather than patched.

Of course, the AMA always threaten these actions annually and thus significant lobbying takes place to pressure lawmakers to provide a solution, yet the system remains flawed and broken. The current Government appears to recognise this, but has been unable to broker a solution and is mired in partisan bickering.

Ultimately, a new plan may emerge in 2010 as part of the ongoing health care reform, but so far, a bipartisan agreement has not been possible to attain. Any proposals being reviewed now may not be the final form that is eventually enacted as law.

The next 10 days may well determine what happens with Medicare reimbursement this year and are likely to have a significant impact on areas such as cardiology and oncology.

New results from a phase II clinical trial of the prostate cancer drug abiraterone suggest that it may help men with advanced disease who have tried standard treatments.

However, a Cancer Research UK clinician cautioned that there were still questions to be answered from ongoing studies about how best to use the drug.

Abiraterone was discovered in the Cancer Research UK Centre for Cancer Therapeutics at The Institute of Cancer Research (ICR) and is taken once a day as four pills.

The latest trial, which was led by the ICR and the Royal Marsden NHS Foundation Trust, is the first to investigate the drug in men with such advanced prostate cancer.

A total of 47 men were recruited for the trial, all of whom had late-stage castration-resistant prostate cancer, which means that their disease was advanced and their tumours were no longer responsive to androgen deprivation therapy. In almost all cases, the men's cancer had spread to their bones.

All of the participants had already received hormone therapy and the chemotherapy drug docetaxel, but were no longer responding to those treatments.

By the end of the study period, researchers found that around three-quarters of men had experienced a drop in levels of prostate specific antigen (PSA), which is often raised in men with prostate cancer and can be used to measure disease activity.

In around half of the men, PSA levels fell by at least 50 per cent, while three-quarters of participants also had a drop in the number of tumour cells circulating in their blood.

Three years after the start of the trial, five of the patients were still taking abiraterone and benefitting from the treatment.

New phase II data on abiraterone was reported this week in the Journal of Clinical Oncology from the researchers at the Royal Marsden.

Standard chemotherapy with docetaxel (Taxotere) improves survival by 2 to 3 months, so if the 6 months seen with abiraterone is repeated in a phase III trial, J&J and Cougar could well have an approval drug on their hands. The other benefit is that the side effect profile is much milder than chemotherapy, which can cause severe myelosuppression in the majority of patients receiving it.

It should be noted that these are advanced patients who have received already several hormonal therapies. The data from this trial will likely provide impetus for larger scale phase III trials, which could be used to seek regulatory approval from the US and EU authorities.

It is clear that the investigators are unclear yet what role and where abiraterone will eventually be used in the treatment paradigm, but traditional research approaches require that trials investigate advanced disease and then more up the continuum as more data and experience with the treatment is gained.

Of course, there is no guarantee that phase III trials will mirror promising phase II results, especially in the cancer arena, but now, it's nice to report on positive data after a bad run of disappointing trials in oncology of late.

Source: JCO (Abstract)

In December 2009, 86% of the total US online population, or 178 million people, viewed video content, compared to 150 million people in December 2008. Americans also viewed a significantly higher number of videos in 2009 compared to the prior year, due to both increased content consumption and a growing number of video ads being delivered. The average online viewer consumed 187 videos in December 2009, up 95% from 96 videos in December 2008.

The number of videos viewed grew almost 150%, from 14.3 billion to 33.2 billion, while the duration of the average video viewed grew 28%, from 3.2 to 4.1 minutes.

Increasing use of video was something that came up at the ePharma conference the other week, which left me wondering:

"Despite the high volume of video use online, the views of Pharma videos are relatively low. What are patient needs in this space?"

Of course, for health information most people would probably prefer to read rather than watch it, but given the popularity of YouTube as shown in the ComScore Digital Year in Review, perhaps it's more a question of understanding more about what people, in this case, consumers and patients actually want.

At the the moment, the available Pharma videos tend to be rather corporate and bland. What if they were used as an education tool to help explain more about the science, the disease, how treatments work or practical, sensible advice on side effect management or how to use the drug if given as an injection?

Thoughts?

Source: ComScore Report accessed at: http://www.comscore.com/layout/set/popup/request/Presentations/2010/The_2009_...

As you may already be aware, one of the primary reasons the National Cancer Institute is building the new Riverside Research Park is to provide space for “synergistic partners” from academia and Industry to work together to cure cancer.  I was just alerted to several new opportunities by my friends at FITCI

A new collaboration opportunity, “Gene Expression Signature Predictive of Response to Chemotherapy” has been added to the NCI Technology Transfer Center web site. Please go to: http://ttc.nci.nih.gov/opportunities/opportunity.php?opp_id=1881

A new collaboration opportunity, “Antibody and Immunotoxin Treatments for Mesothelin-Expressing Cancers” has been added to the NCI Technology Transfer Center web site. Please go to: http://ttc.nci.nih.gov/opportunities/opportunity.php?opp_id=1883

A new collaboration opportunity, “Knockdown and Enhanced Expression of P53 Isoforms to Treat Age-Related Disorders and Cancer” has been added to the NCI Technology Transfer Center web site. Please go to: http://ttc.nci.nih.gov/opportunities/opportunity.php?opp_id=1885

A new collaboration opportunity, “Engineered Biological Pacemakers” has been added to the NCI Technology Transfer Center web site. Please go to: http://ttc.nci.nih.gov/opportunities/opportunity.php?opp_id=1884

A new collaboration opportunity, “Novel Kinase Inhibitors Targeting the PH Domain of AKT for Preventing and Treating Cancer” has been added to the NCI Technology Transfer Center web site. Please go to: http://ttc.nci.nih.gov/opportunities/opportunity.php?opp_id=1882

Interested? Or know someone who might be?

Click on the links to see more details. Spread the word!

(HT Jim Hardy @fredcobio)

At a session at the American Psychoanalytic Association meeting here, Leli said he conducted his first Skype analysis with a Chinese patient in 2004.

"When I did my first Skype analysis, I had many doubts," he said. "Will the analytic process develop? Will there be language differences? Cultural differences?"

He soon began to feel that the Skype analysis was "similar to any type of analysis."

Modern technology can be used to reach and help patients around the world, not just in the doctors office. This example involved a Physicians office in New York and a patient in China for psychoanalysis, both talking on Skype via phone and video.

It's amazing what can be done these days. And then I recall that my own PCP insists on office visits and will barely even use the telephone, except in dire necessity for phoning in a prescription to the local pharmacy. SMS? Never, which is a great shame.

That said, I think it's great that Skype is a great start - imagine what could be done down the line with Cisco's Telepresence?

A team of UK scientists has made the discovery that drugs that target a fault in a protein called BRAF could actually fuel the progression of cancer in some cases.

The findings of the study, which was jointly funded by Cancer Research UK, the Institute of Cancer Research (ICR) and the Wellcome Trust, are published in Cell.

Malignant melanoma is the most deadly form of skin cancer and is difficult to treat successfully once it has spread to other organs.

The BRAF gene is faulty in about half of malignant melanomas and many other cancers, making it a suitable drug target.

Drugs that block BRAF function in cells are already showing positive results in early clinical trials in melanoma patients in the US.

Hot on the post earlier today about anti-angiogenic drugs causing accelerated tumour invasion when used in the short term, this article on BRAF inhibition was also timely and relevant. One BRAF inhibitor in development, sorafenib (Nexavar) also inhibits VEGF.

The consequence of the CRUK research is that patients need to be carefully screened before deciding upon therapy. Those without a faulty RAS gene could be better candidates for BRAF therapy and those with may encourage the cancer to grow. This may provide a good biomarker in diseases such as melanoma.

The findings give new insights into how the drugs work, and ultimately, how the underlying biology affects tumourigenesis and growth.

The cancer stem cell (CSC) concept has important implications for understanding carcinogenesis as well as for the development of cancer therapeutics. According to this concept, tumors are initiated and maintained by a cellular subcomponent that displays stem cell properties. These properties include self-renewal, which drives tumorigenesis, and differentiation (albeit aberrant), which contributes to tumor cellular heterogeneity. The existence of CSCs has been described in a variety of hematologic and solid tumors including those of the breast, brain, colon, pancreas, lung, liver, and head and neck

Cancer stem cells are thought also to contribute to tumor spread (metastasis) and recurrence after treatment, so many researchers are looking at ways of targeting them therapeutically.

Why is this important? According to the article (click on the jci.org link above to access it):

"In addition to intrinsic pathways regulating stem cell functions, normal and malignant stem cells are regulated by extrinsic signals generated in the microenvironment or CSC niche."

What does this mean in simple terms? Well, in breast cancer, the niche is composed of immune cells, mesenchymal cells (fibroblasts, endothelial cells etc) and these aspects play a important role in both normal breast development and carcinogenesis. Thus, if the microenvironment plays a critical role in the regulation of CSC growth, then looking at ways of interfering with the processes could affect the very production of CSC's.

One of the therapeutic strategies being pursued to target CSCs involves inhibition of self renewal or survival pathways in these cells. Normal cells die due to a process known as programmed cell death or apoptosis but in cancer, the cells continue to proliferate, thereby producing tumours.

It now appears that critical pathways involved may include NOTCH, Hedgehog, and WNT. Researchers in Michigan, US and Marseille, France have utlised this knowledge to target human breast cancer stem cells, leading to decreased tumor growth and metastasis in mice xenotransplanted with human breast cancer cells using this approach.

In essence, they found that inhibiting the cell surface protein CXCR1, with either an antibody or a small molecule known as repertaxin, selectively depleted the cancer stem cell population in two human breast cancer cell lines in vitro. Loss of the cancer stem cells was followed by extensive death of many of the remaining tumour cells.

Treatment with repertaxin had similar effects in mice xenotransplanted with human breast cancer cells and cancer stem cells were selectively depleted leading to a reduction in tumor growth and metastasis.

It is possible that strategies targeting CXCR1, the soluble protein that binds to it, or the signaling pathways downstream of it, may provide a new approach to deplete breast cancer stem cells, retarding tumour growth and reducing metastasis.

It will be very interesting indeed to see where this research goes in the future.