Chemotalk Newsletter, Vol. 85: May 1, 2015
Let's get right to it...
DISCOVERY MAY CHANGE THE PRINCIPLES FOR TREATING CERTAIN CANCERS
The discovery relates to the so-called telomeres that constitute the ends of human chromosomes. Short telomeres are related to unhealthy lifestyles, old age and the male gender -- all of which are risk factors in terms of high mortality. Up until now, the assumption has been that short telomeres are related to ill health. The challenge for researchers worldwide has therefore been to find out whether or not the short telomeres were indeed a signifier or an indirect cause of increased mortality.
By studying more than 64,000 Danes from the Oesterbro Study and the Herlev/&Oesterbro Study -- the largest telomere-study ever conducted -- the researchers have reached the conclusion that the genetically determined length of telomeres has no influence on mortality in general. However, humans with genetically long telomeres have an increased risk of dying from CANCER -- which is the exact opposite of what the researchers expected to find. And this new knowledge may thus influence future cancer treatments.
"People have long telomeres because their cells are very apt at maintaining and repairing them. The disadvantage is that cancer cells are also very apt at maintaining and repairing their telomeres, which then prohibits the growth-inhibition that short telomeres would normally induce. If you are able to specifically target this repair process, in principle, you are then better able to stop cancer," says Stig Bojesen, Professor at the Faculty of Health and Medical Sciences at the University of Copenhagen and Chief Physician at Herlev Hospital, who has conducted the study in collaboration with Registrar Line Rode and Professor Boerge Nordestgaard.
The method is called telomerase-inhibition and has been studied as a possible cancer treatment since the mid-00s.
"So far, the method has not managed to fulfill the great expectations initially entertained. However, our discovery highlights that the principle of telomerase-inhibition should be afforded an important place in cancer treatment. The next challenge will be trying to locate more precisely, which cancer patients may benefit the most from such treatment," Stig Bojesen concludes.
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From the Editorial Page of The New York Times:
QUICKER ACCESS TO EXPERIMENTAL DRUGS
The Food and Drug Administration has proposed a greatly simplified process for doctors to obtain experimental drugs for patients who are suffering from serious or life-threatening illnesses and have no other alternative. In a breathtaking reduction of red tape, the simplification should reduce the time it takes a doctor to apply for experimental drugs from 100 hours to less than one hour. Their desperately ill patients can only benefit.
Instead of making doctors provide 26 separate types of information and seven attachments, the new form asks for only eight elements of information, one of which requires the patient's clinical history and the doctor's rationale for wanting to use the experimental drug, and a single attachment.
Although the proposed simplified form won't become final until after a 60-day comment period, the F.D.A. says it won't turn away doctors who want to use it before then.
The proposal was announced by Dr. Peter Lurie, associate F.D.A. commissioner for public health strategy and analysis. Dr. Lurie described the new form as a continuation of a policy that started in the early years of the AIDS epidemic to allow "compassionate use" of experimental drugs even though their safety and efficacy had yet to be demonstrated. That policy has since been broadened but, in the process it has become too complex.
Not every patient who wants an experimental drug can get it. Patients are eligible only when there is no other product that can diagnose monitor or treat the patient's disease or condition and the patient cannot be enrolled in a clinical study testing it. The doctor must determine that the probable risk from the experimental drug is not greater than the probably risk from the disease. And the doctor must ensure that the manufacturer is willing to provide it. The F.D.A. can't compel the manufacturer to provide the drug to an individual; it simply offers guidance on how to do it. Once an application has been filed, the F.D.A. authorizes a vast majority of requests within days or even hours.
The new policy comes on the heels of a campaign by the libertarian Goldwater Institute to persuade states to pass "right to try" laws to make it easier for terminally ill patients to obtain unapproved drugs. So far, "right to try" is now law in five states -- Colorado, Louisiana, Michigan, Missouri and, most recently, Arizona. Some 26 other states have had legislation introduced.
The laws give terminally ill patients the right to try experimental drugs that have passed at least the first of three phases of F.D.A. testing (to determine safety) but are still years away from reaching pharmacy shelves. The laws don't require manufacturers to provide the treatment or insurers to pay for it.
Instead of relying on the F.D.A. to move quickly, the "right to try" laws seek to speed up access by eliminating the F.D.A. from the process entirely. Once a doctor and patient decide that an experimental drug is the right choice, the laws let them apply to the drug company directly.
There are downsides to that approach. Many manufacturers prefer to keep the F.D.A. in the loop. And there could be safety issues in some cases. The F.D.A. has more information about potential risks and benefits of drugs under development than a doctor or patient is apt to know. Thus far, the laws have not helped anyone obtain a drug, but backers are hopeful that some patients will gain access in coming months.
The F.D.A. has no position on the stat "right to try" laws but encourages patients to use its new simplified process for obtaining experimental drugs.
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GENE VERIANTS SHOW POTENTIAL IN PREDICTING RHEUMATOID ARTHRITIS DISEASE OUTCOMES
Arthritis Research UK-funded scientists at The University of Manchester have identified a new way in which genotyping can be used to predict disease outcomes among sufferers of RHEUMATOID ARTHRITIS.
New cohort studies have shown that certain genetic variants are associated with higher or lower risks of increased disease severity. The findings, published in the Journal of the American Medical Association, (JAMA) could in future lead to those patients who are at risk of severe disease being identified early, and also predict who will respond best to treatment.
Data from three independent multi-centre prospective cohort studies were used in the analysis, including a total of nearly 4,000 patients in total. It was found that the amino acid valine at position 11 of the HLA-DRB1 gene was the strongest independent genetic determinant of radiological damage in rheumatoid arthritis. Moreover, it was revealed that positions 71 and 74 represented independent predictors, with the three positions together - 11, 71 and 74 - strongly associated with disease outcomes.
Scientists have long suspected that different genotypes affect arthritis progression in a number of ways, given the condition's variable occurrence rate among different ethnic groups.
The new research also revealed that HLA-DRB1 haplotypes associated with rheumatoid arthritis susceptibility and severe outcomes were also predictors of good treatment response with anti-TNF therapy, an important class of biological drugs pioneered and developed by Arthritis Research UK.
Lead author Dr Sebastien Viatte, of the Arthritis Research UK Centre for Genetics and Genomics at The University of Manchester, said: "This major advance in genetics might allow stratification of rheumatoid arthritis patients at the onset of their disease to identify those at risk of joint damage and early death, and also those who are more likely to respond to anti-TNF biological therapy."
Dr Stephen Simpson, director of research at Arthritis Research UK said: "To treat patients with rheumatoid arthritis more effectively and to prevent them being given drugs which won't work for them, it's important to know who is most likely to respond best to which drug, when and at what dose. This new research takes us a step closer to that goal."
The paper, 'Association of HLA-DRB1 Haplotypes With Rheumatoid Arthritis Severity, Mortality, and Treatment Response,' appeared in the Journal of the American Medical Association.
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This is what can happen when health issues become politicized:
WALKER ADMINISTRATION THREATENS WOMEN'S ACCESS TO CANCER SCREENING AND TREATMENT
By Sara Finger
As a women's health advocate, I celebrated and breathed a great sigh of relief when the Affordable Care Act (ACA) was signed into law in March of 2010. We had finally turned a corner in which being a woman was no longer a pre-existing condition and women could finally afford and access the quality health care we needed and deserved. While I knew my enthusiasm and appreciation was not shared by all, I hadn't quite anticipated the extent to which the law's opponents would quickly use it as an excuse to dismantle other valuable health programs.
In December of 2013, an announcement was made by members of the Wisconsin Department of Health Services (DHS) to dramatically restructure and downsize the Wisconsin Well Woman Program -- a program which has successfully provided CERVICAL and BREAST CANCER screenings to over 70,000 women in our state for over two decades. Under this amazing program, each of Wisconsin's 72 counties had a local coordinating agency to help these tens of thousands of women connect to cancer screening services and treatments from a rich network of area health care providers in their community. With this announcement, leaders under a Republican led administration were justifying a proposal to severely reduce the number of local coordinators and Well Woman Program providers in just six short months by noting that Wisconsin women could now simply find access to cancer screenings and treatments through the federally run health care Marketplace or Medicaid, thanks to the ACA. This new found faith in "Obamacare" was especially ironic coming from Governor Scott Walker's administration, which has very openly taken every measure possible to undermine the ACA in Wisconsin. The same administration that refused to set up a state health care exchange, refused to accept the federal Medicaid expansion, and requested that our attorney general join a lawsuit challenging the constitutionality of the law, was now positioning the ACA as a life boat to help low-income women detect and treat cancer.
Advocates, program coordinators, cancer survivors and health care providers -- none of whom were consulted when designing the program's restructure -- immediately called for the proposed changes to be delayed, fearing that a drastic restructuring of the program would blow up a critical "bridge" during a time of enormous health care coverage transition for thousands of disadvantaged women in the state. Architects of the program redesign failed to provide any details related to which of the current women served by the program would now be eligible for the Marketplace or Medicaid. In a state that rejected full Medicaid expansion, no one could guarantee that low income women wouldn't fall through the coverage and affordability gaps without the Well Woman Program. No one could point to a specific plan to help program clients navigate new options and enroll in new coverage. Fortunately, in response to public pressure, initial restructuring plans were delayed -- until now.
After a year of stalling and going through the motions of gathering stakeholder input, state DHS leaders are now moving ahead with plans to (surprise!) minimize the number of local coordinating agencies and to limit the number of health care providers eligible to serve Well Woman Program clients. Still void of details or data, DHS administrators are still putting their blind faith into in the ACA life boat, in which the Walker Administration seems eager to pop holes -- especially now that the Governor has found himself in the national presidential campaign spotlight.
Some will argue that Wisconsin women have and will continue to stumble and find their way to new health care coverage and that BadgerCare (Wisconsin's Medicaid program) and the Federal Marketplace will pick up the pieces of the Well Woman Program. But for those of us with eyes wide open watching the Governor make additional damaging changes to BadgerCare in the state budget and waiting for the Supreme Court to decide the fate of the Marketplace subsidies with the King v. Burwell Supreme Court case, we have never been more fearful about compromising a life-saving program like the Well Woman Program.
The current state budget actually maintains funding for the Well Woman Program. As of today, all 72 local coordinating agencies are still in place and operational and the rich network of local health care providers are still in contract to provide services. That being said, our state leaders have a small window of opportunity to do the right thing by once again delaying any changes to the program and maintaining the integrity of the program as is. If our leaders can't guarantee that women won't fall through the coverage and affordability cracks and that women won't come surging back to a compromised Well Woman Program if changes are made to BadgerCare and the Marketplace subsidies, then they shouldn't be so quick to pull the trigger on their unfounded plans. Women's health and lives should come before political posturing. You can't root for a law to fail while depending on that same law to meet the critical needs of women. Leaders must maintain the integrity of the Wisconsin Well Woman Program and ensure Wisconsin women can access the life-saving cancer screenings and treatments they need and deserve.
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And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com.