Show up at the emergency room or your doctor’s office with symptoms of a serious infection, and there’s a good chance you’ll get an antibiotic. You might even get a few.
But antibiotics don’t work on viruses. And a particular antibiotic may be suited for one kind of germ, but not another.
The problem for your doctor — and you — is that it can take days to grow enough of the germs afflicting you to identify them conclusively using traditional tests. And if you’re really sick, the doctor may try a bunch of antibiotics right away, just to be sure one of them starts getting you back on the road to health….
Faster, more specific tests would help. And the Food and Drug Administration has recently approved some. This week, while you might have been distracted by the Supreme Court, the agency cleared a test for a dozen bacteria that cause infections in the blood.
“Bloodstream infections are always treated with antimicrobial drugs, and it is essential to identify which antimicrobial drug is appropriate for a specific patient as quickly as possible,” FDA’s Alberto Gutierrez said in a statement. “This new test is an important tool that will help physicians treat patients quickly with the correct antibiotics.”
The test, made by Nanosphere, works in a few hours instead of days. It fingerprints the germs’ DNA and can even detect when the bugs carry genes that render them resistant to some antibiotics. The test costs less than $100….
- Fast Tests Are Latest Weapons Against Infections (wnyc.org)
- FDA Approves Bloodstream Bacteria Test (medicalnewstoday.com)
- Germs Behind Urinary Tract Infections Becoming More Resistant to Drugs (nlm.nih.gov)
- Antibiotics binge helping superbugs spread (abc.net.au)
- WHO demands action on drug-resistant gonorrhoea (newscientist.com)
DNDi welcomes World Health Organization expert recommendations to begin negotiations for an R&D convention at the World Health Assembly
After a decade-long process of analysis and deliberations on ways to better address the health needs of developing countries, a recently released report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) will be discussed this week at the 65th World Health Assembly (agenda item 13.14). The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, welcomes the experts’ conclusion that ‘the time has now come for WHO Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries’.
A decade ago, R&D for poverty-related neglected diseases was at a virtual standstill. Since then, there have been significant changes in the landscape for these diseases, with now some 150 new R&D projects, including for drugs, diagnostics, and vaccines, in the pipeline. This progress stems from international pressure and the engagement of new public and private actors and donors in both endemic and non-endemic countries, as well as initiatives such as product development partnerships (PDPs), which were set up to fill the gaps left by policy and market failures.
However, despite incremental progress, the essential health needs of the vast majority of the world’s population are still largely unmet, current R&D efforts are still too fragmented, and financing is still far too fragile. Genuine therapeutic breakthroughs that are adapted to the needs of patients in resource-limited settings and that have the potential to fundamentally transform the treatment of many neglected diseases, notably those with the highest death rates, have yet to make their way through costly clinical trials and reach patients in need.
- Expert Group Recommend That World Health Assembly Should Adopt An International Convention On Global Health R&D (medicalnewstoday.com)
- WHO: Sixty-fifth World Health Assembly (crofsblogs.typepad.com)
- Global Health R&D Needs To Be Harmonized (medicalnewstoday.com)
- World Health Assembly should adopt an international convention on global health R&D: Expert group (medicalxpress.com)
- An international treaty is needed to improve medical research worldwide (eurekalert.org)
- We need a global treaty on health research for the poor (scidev.net)
Unnecessary reliance on screening tests and the underuse of personalized medicine are two major concerns I have with the present practice of medicine. Hence the selection of this article for a blog item.
Mayo’s Dr. Victor Montori and his team argue that medical intervention success is best be measured in holistic terms as death, quality of life, and ability to function. This is in direct opposition to current industry and professional guideline standards which emphasizes narrow (and often misleading) outcomes as blood pressure reduction, lipid levels, and glucose levels.
The team’s analysis with “10 commandments” for physicians is published in the 28 December 2011 article The idolatry of the Surrogate. The article, unfortunately, is only available through paid subscription through the BMJ (British Medical Journal – Helping Doctors Make Better Decisions).***
The commandments basically encourage physicians to be careful with statistical results from clinical trials, information from industry experts, and to treat and respect the patient as individual with treatment related statistics as guides.
On a related note, I am very impressed with folks who empower themselves in treatment decisions by keeping up with biomedical breakthroughs, new treatments, and new ways of looking at diseases. I have posted related blogs as ePatients: The hackers of the healthcare world and Meet e-patient Dave – a voice of patient engagement.
Here is the abstract of the article
Easier to measure surrogate outcomes are often used instead of patient important outcomes such as death, quality of life, or functional capacity when assessing treatments. John Yudkin, Kasia Lipska, and Victor Montori argue that our obsession with surrogates is damaging patient care
Diabetes care is largely driven by surrogates. The US Institute of Medicine defines surrogates as “biomarker[s] intended to substitute for a clinical endpoint [and] expected to predict clinical beneﬁt (or harm . . .) based on epidemiologic, therapeutic, pathophysiologic, or other scientiﬁc evidence.”1 In diabetes, concentrations of glycated haemoglobin (HbA1c) are used as a surrogate marker for outcomes that are important to patients, such as blindness or amputation. Other surrogates such as blood pressure, lipids, albumin excretion rates, and C reactive protein have been used to predict outcomes of cardiovascular disease and to guide clinical practice in people with or without diabetes. Much of the evidence for clinical interventions is based on their effect on surrogate outcomes rather than those that matter to patients such as quality of life or avoidance of vision loss or renal failure. Moreover, because these “hard” end points generally show much smaller responses to interventions than surrogate markers, many of the widely accepted strategies for diabetes may be based on artificially inflated expectations.
Recent studies have challenged the assumption that reliance on surrogates can accurately predict the effect of treatment on hard outcomes. There are the oral hypoglycaemic drugs that reduce HbA1c but increase the risk of cardiovascular events,2 antihypertensive drugs that do not reduce the risk of stroke,3 and drugs that improve cholesterol profiles but do not reduce cardiovascular events.4 Explanations for such phenomena include unwanted effects of the drug or an incomplete understanding of the pathophysiology of the disease.5 But why have …
Below are listed the the ten commandments**** with definitions and paraphrasing. I have forgotten much more than I have remembered from a college statistics class 30+ years ago! The “explanations” are a result of finding quality information on the Internet.
(For a great “translation” with less math, please go to the blog posting …Get Your Doctor to Treat You Right)
The New Therapeutics: Ten Commandments
- Thou shalt treat according to level of risk rather than level of risk factor.
Level of risk - these levels are experienced by everyone, not just those having the disease being treated [good summary of risk levels (minimal, less than minimal, greater than minimal) ]
Risk factor -anything that makes it more likely you will get a disease, either something you do (smoking)or something you have no control over (as being over 50 makes it more likely you will get colon cancer. People should be given treatments based on the risks associated with the treatment on anyone,not individual factors (age, blood pressure, other conditions)
- Thou shalt exercise caution when adding drugs to existing polypharmacy.
Polypharmacy - (poly is Greek for many) Whenever a person is taking a drug, any additional drugs may interact and cause bad reactions, including death.
- Thou shalt consider benefits of drugs as proven only by hard endpoint studies.
Endpoint study – research study involving humans where the outcomes (results) directly address the question. For example, if a drug was tested on how it reduced heart disease, the hard endpoint would be the reduction of heart disease. However, hard endpoint studies are usually not accomplished in short periods of time, because it takes time for diseases to develop. This paragraph sums up endpoint workarounds well.
From Deciphering Media stories on Diet (Harvard.edu)
4. Did the study look at real disease endpoints, like heart disease or osteoporosis? Chronic diseases,
like heart disease and osteoporosis, often take many decades to develop. To get around waiting that
long, researchers will sometimes look at markers for these diseases, like narrowing of the arteries or
bone density. These markers, though, don’t always develop into the disease.
- Thou shalt not bow down to surrogate endpoints, for these are but graven images.
Surrogate endpoint – a substitute endpoint in a clinical trial. It is not the item being measured directly (as heart disease), but an item related to what is being studied (as blood pressure). During the study these substitutes will be used to check on the health of the people in the clinical trial, the usefulness of the drug being treated, and if there are any complications. Surrogate endpoints are substitutes for (true) clinical endpoints (as survival for 5 years after the treatment). Surrogate endpoints don’t always guarantee a clinical endpoint (just because blood pressure goes down, heart disease may not be treated). However studies with good endpoints are expensive (require testing on many people) are take long periods of time. [Adapted from an eHow article with good references]
- Thou shalt not worship Treatment Targets, for these are but the creations of Committees.
Correlation doesn’t always meant causality!A treatment target is a goal of a treatment intervention. An example would be to reduce a specific protein in order to prevent a specific cancer (Potential New Treatment Target for Retinoblastoma, 13 January 2012 Medscape article) . The “cause/effect” relationship between something measurable (as a protein) and a disease may not truly exist. It is also possible that the presence of the protein and the onset of a disease may be due to other factors in a web of events.
- Thou shalt apply a pinch of salt to Relative Risk Reductions, regardless of P values, for the population of their provenance may bear little relationship to thy daily clientele.
Relative Risk – The number of times more likely (RR > 1) or less likely (RR < 1) an event is to happen in one group compared with another. [From the BMJ glossary] P value – a number used to show how a variable (as a drug treatment) has a different result thano variable (no treatments). So, a high P value would seem to point to an effective drug treatment.
- Thou shalt honour the Numbers Needed to Treat, for therein rest the clues to patient-relevant information and to treatment costs.
The Numbers Needed to Treat (NNT) tells how many patients need a specific treatment in order to prevent an additional bad outcome (as a heart attack or stroke). So if a drug has an NNT of 10, 10 people have to be treated with the drug in order to prevent one additional bad outcome.
For example, if a drug is found to reduce the risk of a bad outcome from 50% to 40%, the absolute risk .1 (the difference). And the NNT is the inverse of the absolute or 10. [From Numbers Needed to Treat (Patient.co.UK)
- Thou shalt not see detailmen, nor covet an Educational Symposium in a luxury setting.
Detailmen are pharmacy representatives who present doctors with their company’s drug information with the aim of persuading the doctor to presribe their drugs. These representatives often sponsor educational talks (often “focusing” on conditions rather than drugs) at physician meetings. These “luxury settings” may included free buffets and hospitality rooms. [From Influencing Doctors :How Pharmaceutical Companies Use Enticement to 'Educate' Physicians (ABC News)]
- Thou shalt share decisions on treatment options with the patient in the light of estimates of the individual’s likely risks and benefits.
- Honour the elderly patient, for although this is where the greatest levels of risk reside, so do the greatest hazards of many treatments.
*** Click here for suggestions on how to get this article for free or at low cost.
In past blogs I have posted items on initiatives for the wider sharing of scientific articles to the public with subsidies, open access, etc.
****Richard Lehman’s Journal Review – 3 January 2012
As part of its ongoing efforts to ensure safe, effective and appropriate medical imaging, the American College of Radiology has joined the ABIM Foundation and eight other medical specialty societies in Choosing Wisely. The new campaign promotes wise choices by physicians and patients to improve health outcomes, avoid unnecessary interventions and make efficient use of healthcare dollars.
The ACR will develop a list of five things to reduce unnecessary imaging exams ordered by physicians and improve quality of care. The list names imaging exams whose necessity should be discussed before being ordered. The list also equips providers with steps to help ensure safe, appropriate use of scans.
“Medical imaging exams are a perfect fit for Choosing Wisely. Scans lower healthcare costs by replacing more invasive surgeries and allowing for shorter hospital stays. Although imaging use is down significantly since 2008 and Medicare spending on imaging is the same as in 2004, opportunities remain to ensure appropriate ordering of scans. As greater access to imaging is directly tied to increased life expectancy, ACR will identify areas where care can be improved without restricting patient access,” said John A. Patti, MD, FACR, chair of the ACR Board of Chancellors……
The ACR list, and those of other Choosing Wisely partners, will be released in April 2012. To learn more, visit ChoosingWisely.org.
This series of six video vignettes featuring physicians and patients emerged from research the ABIM Foundation conducted to better understand public and professional attitudes about stewardship of finite resources. Watch the videos.
- ACR in Choosing Wisely campaign to promote wise use of resources among physicians and patients (medicalxpress.com)
According to a story in today’s New York Times, a study conducted by reaserchers from the University of Oxford and the Kenya Medical Research Institute demonstrated that texting treatment tips to healthcare workers increased the number of cases that they handled correctly and six months later, the effect was still there.
“Since each text cost less than a penny, every nurse in rural Kenya could get reminders for $39,000, the study said. That is far cheaper than sending trainers or brochures, neither of which improved care much, the authors said.”
The original report was published in The Lancet.
- Study finds text messages help smokers quit (pakistannewsupdate.wordpress.com)
- Cellphones Boost Health Across Globe (livescience.com)
The US Agency for Healthcare Research and Qualtiy (AHRQ) publishes a wealth of information for consumers and patients on staying healthy, choosing medical care, understanding diseases and conditions, and comparing medical treatments.
For example, Explore Your Treatment Options gives sound advice on
- Why one should explore treatment options
- Tips on how to start the conversation about treatment options with doctors
- Rating health priorities through a check list type tool. The questions ask you to rate ease of every day activities, concerns about treatment side effects, and basic questions about treatment time, cost, and effort. Results may be printed to share with your doctor.
- Links to Treatment Guides (cancer, diabetes, heart conditions, and more)
(Garrison, NY) In a feature article in The New Republic,(subscription only, check your local public library for availability) Daniel Callahan and Sherwin Nuland propose a radical reinvention of the American medical system requiring new ways of thinking about living, aging, and dying. They argue that a sustainable—and more humane— medical system in the U.S. will have to reprioritize to emphasize public health and prevention for the young, and care not cure for the elderly.
An interesting twist on their argument, which would aim to bring everyone’s life expectancy up to an average age of 80 years but give highest priority for medical treatment to those under 80, is that Callahan and Nuland are themselves 80 years old. Daniel Callahan, Ph.D., is cofounder and president emeritus of The Hastings Center and author most recently of Taming the Beloved Beast: How Medical Technology Costs Are Destroying Our Health Care System. Sherwin Nuland, M.D., is a retired Clinical Professor of Surgery at the Yale School of Medicine and author of How We Die and the Art of Aging. He is also a Hastings Center Fellow and Board member.
“The real problem is that we have medicine excessively driven by progress, which aims to rid us of death and disease and treats them as the targets of unlimited medical warfare,” said Callahan and Nuland. “That warfare, however, has come to look like the trench warfare of World War I: great human and economic cost for little progress. Neither infectious disease nor the chronic diseases of an aging society will soon be cured. Cancer, heart disease, stroke, and Alzheimer’s disease are our fate for the foreseeable future. Medicine and the public must adapt it to that reality, one that has mainly brought us lives that end poorly and expensively in old age.”
The article notes that the Affordable Care Act might ease the financial burden of this system, but not eliminate it. It reports, for example, that the cost of Alzheimer’s disease is projected to rise from $91 billion in 2005 to $189 billion in 2015, and to $1 trillion in 2025 – twice the cost of Medicare expenditures for all diseases now.
“We need to change our priorities for the elderly. Death is not the only bad thing that can happen to an elderly person,” the authors write. “An old age marked by disability, economic insecurity, and social isolation are also great evils.” They endorse a culture of care, not cure, for the elderly, with a stronger Social Security program and a Medicare program weighted toward primary care that supports preventative measures and independent living.
Callahan and Nuland point the way to a more sustainable path that reprioritizes the entire system. Among their recommendations:
- improve medicine at the level of public health and primary care, while reducing its use for expensive high-tech end-of-life care;
- shift resources for the elderly to greater economic and social security and away from more medical care;
- subsidize the education of physicians, particularly those who go into primary care, and decrease medical subspecialization;
- train physicians better to tell the truth to patients about the way excessively aggressive medicine can increase the likelihood of a poor death;
- shift the emphasis in chronic disease to care rather than cure;
- conduct a top-down, bottom-up, long-range study of the entire American system of health care, including the training of physicians, with a view toward reconstituting it along systematic lines that take science, humanistic concerns, economics, and social issues into account.
- Andrew Reinbach: Health Care Could Kill Us: We Don’t Have to Let It (huffingtonpost.com)
- New at Reason: Ronald Bailey on Health Care Reform (reason.com)
ScienceDaily (Apr. 11, 2011) — The act of making a recommendation appears to change the way physicians think regarding medical choices, and they often make different choices for themselves than what they recommend to patients, according to a survey study published in the April 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals…
[For suggestions on how to get this article for free or at low cost, click here]
..”In conclusion, when physicians make treatment recommendations, they think differently than when making decisions for themselves,” the authors conclude. “In some circumstances, making recommendations could reduce the quality of medical decisions. In at least some circumstances, however, such as when emotions interfere with optimal decision making, this change in thinking could lead to more optimal decisions. In debating when it is appropriate for physicians to make treatment recommendations to their patients, we must now recognize that the very act of making a recommendation changes the way physicians weigh medical alternatives.”
Proteomics Research Heading Towards Personalized Treatments For Cancer, Diabetes And Inflammatory Diseases
NeoProteomics Inc., a biomarker development and software company, has secured an exclusive option agreement with Case Western Reserve University. The deal has potential to enhance various forms of treatment of cancer, diabetes, and inflammatory diseases. Proteomics is the scientific next step in vital research of protein structures of biological systems. NeoProteomics, founded in 2006 in Cleveland near Case Western Reserve’s School of Medicine, focuses on biomarker identification and validation and seeks to spearhead the development of unique and improved analysis tools…..
- Researchers identify new biomarker for Creutzfeldt-Jakob disease, the human form of mad cow disease (eurekalert.org)