The United States spends more on medical care per person than any country, yet life expectancy is shorter than in most other developed nations and many developing ones. Lack of health insurance is a factor in life span and contributes to an estimated 45,000 deaths a year
Only one man seems to have ever been cured of AIDS, a patient who also had leukemia. To treat the leukemia, he received a bone marrow transplant in Berlin from a donor who, as luck would have it, was naturally immune to the AIDS virus.
I'm getting to the age where the death of family and friends is starting to happen more frequently. Just before the recent American Society of Hematology meeting, the news hit the Pharma grapevine that two old Novartis colleagues had both sadly died in their 40's.
That was a bit of shock. The fragility of life, of light and darkness, really hits you at moments like these.
Ned Calonge, MD, chairman of the USPSTF said the guidelines, which have drawn a “remarkable amount of attention,” were communicated poorly.
The group did not mean to tell the public that women under 50 shouldn’t have mammograms, Calonge said, rather, it meant to convey that the test for women under 50 is supported by only limited clinical evidence, and that all women should discuss the risks and benefits with their physicians.
Interesting that the task force chairman has finally clarified the USPSTF’s position amongst all the misinformation, misinterpretation and miscommunication surrounding the mammogram guidelines.
What’s surprising is that there was:
a) no radiologist on the committee b) no formal communication plan to patients and physicians
The end result?
A major controversy that could have been largely avoided with more thought for the consequences of a “C” grade i.e. limited evidence supporting mammograms under 50 so patients would be informed of the risk-benefit trade-off before deciding upon whether to undergo testing.
Although medical services receiving an A or B grade will likely get compulsorily covered by insurance companies, it is still unclear what will happen with C grade procedures.
Caveat emptor. A storm that surely could have been avoided.
It seems that the lack of attention to risk information was highest in those 55+.
Interestingly, the chief research officer for the study by ORC guideline suggested that:
“As consumers utilize a wide variety of sources to learn about prescription medications, it may not be optimal for the FDA to require that pharmaceutical companies include the same details in each of the channels they use to communicate information about their prescription drug products.”
The value of independent websites in providing accurate and fair balanced information is growing in importance, especially as the study also demonstrated that only half (50%) pay attention to disclosures in print ads. Whether this is due to information overload or the small size of the print is, however, unclear.
On Friday, many of us interested in hematology and oncology will be heading to New Orleans and the annual American Society of Hematology (ASH) meeting. Every year, I like to try and predict what might be hot topics beforehand, although I'm not always right!
So without breaking any embargoes, based on companies, drugs, and data that I've been following this year, here's my list of Pharma companies to watch out for:
Celgene:Revlimid is doing well in the refractory setting and will likely have some stunning data in the front-line setting in multiple myeloma. Data was released in July this year suggesting that patients live longer on the drug, paving the way for maintenance therapy as a viable option. This is not good news for Millennium and J&J in the long run, who promote Velcade. However, in the short term, Millennium still have a huge advantage over their rivals given they they have demonstrated long term survival data in the newly diagnosed setting, which Revlimid does not have. It's clearly time to step up the R&D and marketing efforts a few notches now that the competition is getting hot. Millennium do have a promising neddylation inhibitor, MLN4924, up their sleeve and I'm looking forward to seeing the latest data on that too.
Novartis:Tasigna front-line data is being presented as a late breaking abstract suggesting that is achieves deeper and earlier complete cytogenetic responses than Gleevec, the standard of care. It looks like the company will have likely beaten BMS and Sprycel in the race to file the 2nd generation TKI's in newly diagnosed CML. Afinitor is being developed beyond renal cell carcinoma in many indications, including NHL.
GSK:Arzerra has now been approved for the treatment of chronic lymphocytic leukemia (CLL) in patients who have become refractory to fludarabine and alemtuzumab. Updated data in NHL is expected at this meeting.
Biotech companies also look to be well represented, although most of the data will be phase I and II, rather than big phase III studies:
Onyx/Proteolix: Carfilzomib is a 2nd generation proteasome inhibitor that appears to spare patients some of the peripheral neuropathy associated with Velcade. The agent has been doing well in trials to date and new, mature data is expected at ASH.
Ariad: AP24534 is a TKI which appears to inhibit the T315i mutation not targeted by imatinib, dasatinib or nilotinib. Although this mutation is rare, it is fatal as there are no approved options to target it at present.
AEtena Zentaris/Keryx: Developing perifosine in myeloma. Combination data with Velcade and dexamethasone is expected to be presented at ASH, see the link to the press release on the poster below.
Seattle Genetics: Have had a rocky ride lately with the halting of dacetuzumab in combination with rituximab in diffuse large cell B-lymphomas but are presenting an update at the meeting. They have another compound, brentuximab, in development for CD-30+ lymphomas.
Trubion: TRU-016 is an anti-CD37 small modular immunopharmaceutical (SMIP™) protein in development for CLL, which they licensed from Facet. It's far to early to tell whether this agent has any promise, but worth watching, just in case.
Of course, there are also some others, such as Allos Therapeutics pralatrexate and Gloucester Pharma's romidepsin, but these have been recently approved in rare forms of NHL, ie PTCL and CTCL respectively. It will be interesting to see how and where they plan to expand to other indications outside the orphan drug designated initial approvals.
Calistoga and Semafore are both developing PI3 Kinase inhibitors in hematologic indications such as refractory B-cell malignancies and myeloma, respectively. The data is still very immature, being phase I trials, but worth looking at since many of the big pharma company PI3 kinases are being tested in solid tumours rather than hematological cancers.
I'll be posting daily reports from the ASH meeting, so watch this space!
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
MIT cancer biologists have identified a subpopulation of cells that can give rise to pancreatic cancer. They also found that tumors can form in other, more mature pancreatic cell types, but only when they are injured or inflamed, suggesting that pancreatic cancer can arise from different types of cells depending on the circumstances.
We do believe that we should aim to choose 100% of the benefit. We should not forget that the “benefit” in this situation is reducing deaths from breast cancer. A 30% reduction in saving lives is not acceptable. We also recognize that mammograms are not perfect. We realize that women do have to get additional studies for suspicious lesions. We realize that some women have biopsies that do not show breast cancer. We realize that our predictive tests are not perfect, so that we can’t say with certainty which breast cancers are aggressive and require intensive treatment and which would—if left alone—never cause a problem. We realize that we need better screening tools, and that we must work diligently to improve the quality of screening mammography across the country. Until we have something better, what we have to work with to detect breast cancer early is the screening mammogram. Is it imperfect? Yes. Has it saved lives and reduced deaths from breast cancer? Absolutely.
The role of PI3K/PTEN/AKT/mTOR genetic variation in clinical outcomes following chemoradiotherapy for esophageal cancer – The American Journal of Hematology / Oncology (AJHO)
Key research findings:
● Genetic variation in the core components of the PI3K/ PTEN/AKT/mTOR signaling pathway influences recurrence risk, overall survival, and response to chemoradiotherapy for esophageal cancer patients
● A cumulative effect and higher-order interactions among single nucleotide polymorphisms (SNPs) associated with recurrence risk were identified
● A single SNP in AKT2 — rs892119 — was associated with a poor clinical outcome based on all 3 endpoints
Committee Leaders Call for GAO Analysis of Recent Prescription Drug Price Increases
Leaders of the House Ways and Means and Energy and Commerce Committees sent a letter to the Government Accountability Office (GAO) last night requesting an expedited report on recent trends in prescription drug pricing.
Ned Calonge, who chairs the 16-member panel, defended the recommendations and denied that cost or the debate over health-care reform played any role in the decision. "Cost just isn't a consideration when the task force deliberates," said Calonge, who is also the chief medical officer for the Colorado Department of Public Health and Environment. Twelve of the task force members were seated during the Bush administration, and the remaining four were chosen before President George W. Bush left office, he said.
new study which uses modeling to summarize the benefits and harms of breast cancer screening finds that regular mammography screening for women ages 50 to 74 reduces the risk of dying due to breast cancer, with a smaller benefit for women 40 to 49.
National statistics show that about 18 percent of all breast cancers occur in women aged 40-49, and, at Johns Hopkins, more than one in four breast cancer patients are among this age group. We also know that breast cancers occurring in women under 50 tend to grow faster and more aggressively than in older women and arise in denser tissues, making their early detection more difficult.
The U.S. Preventive Services Task Force (USPSTF) recommends screening mammography, with or without clinical breast examination (CBE), every 1-2 years for women aged 40 and older.
Grade: B Recommendation.
Way back in 1997, a committee of a dozen experts convened by the National Institutes of Health heard testimony, reviewed the scientific literature and mulled what to tell doctors and women in their 40s about screening for breast cancer.
After weighing the risks and benefits, they concluded:
[T]he data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography.
The kinases, Chk1, Wee1, and Myt1 are key regulators of the G2 checkpoint, which act directly or indirectly to inhibit Cdc2 activity. Show that RNA interference (RNAi)-mediated downregulation of Wee1 kinase abrogated an Adriamycin trade mark -induced G2 checkpoint in human cervical carcinoma Hela cells that are defective in G1 checkpoint response. Wee1 downregulation sensitized HeLa cells to Adriamycin-induced apoptosis.
G2 checkpoint abrogation by PD0166285 was demonstrated to kill cancer cells, there at a toxic highest dose of 0.5 muM in some cell lines for exposure periods of no longer than 6 hours. The deregulated cell cycle progression may have ultimately damaged the cancer cells. Used in mouse melanoma cell line model.
The inhibition of Wee1 kinase by a selective small molecule inhibitor significantly enhances the anti-tumor efficacy of DNA damaging agents, specifically in p53 negative tumors by abrogating S-G2 checkpoints, while normal cells with wild-type p53 are not severely damaged due to the intact function of the G1 checkpoint mediated by p53. Since the measurement of mRNA expression requires a very small amount of biopsy tissue and is highly quantitative, the development of a pharmacodynamic (PD) biomarker leveraging mRNA expression is eagerly anticipated in order to estimate target engagement of anti-cancer agents.
Wee1 is a tyrosine kinase that phosphorylates and inactivates CDC2 and is involved in G2 checkpoint signaling. Reported the discovery of a potent and selective small-molecule inhibitor of Wee1 kinase, MK-1775. This compound inhibits phosphorylation of CDC2 at Tyr15 (CDC2Y15), a direct substrate of Wee1 kinase in cells. The data indicate that Wee1 inhibition provides a new approach for treatment of multiple human malignancies.
Where do members of the public turn to understand what genetic tests mean in terms of their own health? Now that genome-wide association studies and complete genome sequencing are widely available, the importance of education in personalized genomics cannot be overstated. Although some media have introduced the concept of genetic testing to better understand health and disease, the public’s understanding of the scope and impact of genetic variation has not kept up with the pace of the science or technology.
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