Wednesday, October 26, 2011

amednews: Healthy People 2010 misses targets on obesity and health disparities :: Oct. 24, 2011 ... American Medical News

amednews: Healthy People 2010 misses targets on obesity and health disparities :: Oct. 24, 2011 ... American Medical News

The nation's health improved during the past decade as adult cholesterol levels decreased and fewer people smoked cigarettes, according to the final review of Healthy People 2010. Such improvements led to an increase in life expectancy.

But the country fell short of meeting Healthy People 2010 goals in some of the most critical areas, including reducing obesity and health disparities.

Obesity prevalence increased across all age groups during the last decade. Minorities, people with low incomes and those with limited education experienced widening disparities in areas such as coronary heart disease deaths and exposure to tobacco smoke.

"Overall, we did a fabulous job in terms of moving forward and improving health in the past decade. ... I'm proud we made progress, but we still have so much work to do," said Carter Blakey, acting deputy director of the Office of Disease Prevention and Health Promotion in the Dept. of Health and Human Services.

Blakey said primary care physicians play an integral role in improving public health and are key to helping the nation meet the Healthy People 2020 targets, which were released in December 2010. She encourages doctors to counsel patients on good nutrition, physical activity and smoking cessation.

"Physicians are busy and see a long list of patients every day, but ... if they could really counsel on these issues at the individual level, they can help make a difference," Blakey said.

The Healthy People program has been issued by HHS every decade since 1980. The initiative provides benchmarks to track and monitor progress that can guide action to improve the nation's health.

The final review of Healthy People 2010, released Oct. 6, shows that targets were met for 23% of the 733 objectives. For objectives in which the goal was not achieved, progress was made in nearly half of the cases.

The nation's health got worse for 24% of objectives, and there was no change for 5% of the initiatives.

Among the key findings: Life expectancy for the U.S. population increased from 76.8 years in 2000-01 to 77.8 years in 2006-07. That improvement reflects declining death rates for a variety of conditions, including female breast cancer, coronary heart disease, prostate cancer and stroke, the report shows.

Deaths due to prostate cancer decreased beyond the Healthy People target, falling from 31.1 deaths per 100,000 people in 1999 to 23.5 deaths per 100,000 in 2007. Death rates related to other cancers improved, but did not exceed the goals set for them.

The number of adults and teenagers who smoke also declined. In 2008, 21% of adults 18 and older smoked cigarettes compared with nearly one in four in 1998. In 2009, 19% of students in grades nine through 12 smoked, down from 35% in 1999.

"Despite many areas for optimism, addressing health disparities continues to be our greatest challenge," said Edward Sondik, PhD, director of the National Center for Health Statistics.

Reducing health inequalities
Overall, disparities remained unchanged for about 80% of the objectives, according to the report.

For example, minority and low-income groups continue to be less likely to have a regular source of medical care. Cigarette smoking also remains more common among the poor and those with less education compared with college graduates who have higher incomes.

Health disparities worsened in 13% of the objectives. Deaths due to coronary heart disease is one area where disparities increased for minorities and people with no more than a high school degree.

Also concerning to public health experts is that little progress was made meeting nutrition and weight targets.

The amount of obese adults 20 and older climbed from 23% between 1988 and 1994 to 34% between 2005 and 2008. During that period, obesity among children 6 to 11 increased from 11% to 17%.

To help remedy the problem, physicians should give patients more practical ways to improve their nutrition and physical activity, said Thomas LaVeist, PhD, director of the Hopkins Center for Health Disparities Solutions in the Johns Hopkins Bloomberg School of Public Health in Baltimore.

Rather than instructing patients to eat less salt, sugar and fat, he encourages doctors to give them examples of nutritious alternatives.

"We need to do a better job of providing people with information in a way they can understand," LaVeist said.

Friday, October 14, 2011

Cardiac Risk in Diabetes Often Overestimated

Cardiac Risk in Diabetes Often Overestimated

DENVER – Diabetes patients with stable symptoms of coronary artery disease appear to have a lower cardiac event risk than previously thought.

The yearly rate of cardiovascular death or nonfatal MI was just 2.4% in a series of 444 consecutive diabetes outpatients with symptoms suggestive of coronary artery disease (CAD) who underwent exercise treadmill or pharmacologic stress single-photon emission computed tomography (SPECT) myocardial perfusion imaging. The cardiovascular death rate of 0.4% per year and the nonfatal MI rate of 2.0% per year were surprisingly low, given that 39% of subjects had known CAD and the rest had symptoms suggestive of CAD, Dr. Jamieson M. Bourque noted at the annual meeting of the American Society of Nuclear Cardiology.

The explanation may be found at least in part in contemporary evidence-based intensive medical management for risk reduction in this traditionally high-risk population, added Dr. Bourque of the University of Virginia, Charlottesville.

Of the 444 symptomatic diabetes patients, 78.5% had no inducible ischemia on stress SPECT myocardial perfusion imaging, 16.5% had 1%-9% left ventricular ischemia, and 5% had left ventricular ischemia of at least 10%. Again, these are lower rates than would be expected based on historical data taken from the era before aggressive risk factor modification in patients with diabetes and CAD symptoms.

During a median 2.4 years of follow-up, the combined rate of cardiovascular death, nonfatal MI, or revascularization more than 4 weeks after myocardial perfusion imaging was 32% in patients with at least 10% left ventricular ischemia on their presenting SPECT study, 14% in those with 1%-9% ischemia, and 8% in those with no ischemia.

Patients who achieved at least 10 METs (metabolic equivalents) on the treadmill during testing had the best prognosis. The sole event that occurred in this subgroup was a late revascularization.

In all, 60% of hard cardiac events occurring in this study were in patients with no perfusion defects. This points to the need for improved patient selection and risk stratification techniques in diabetes patients, according to Dr. Bourque.

He declared having no financial conflicts.

Interactive Movie - What's in the pipeline? - New Scientist

Interactive Movie - What's in the pipeline? - New Scientist
What's in the pipeline?
We've taken a peek at what products the big vaccine producers have up their sleeves. It's a varied bunch – from a vaccine to protect you against bird flu to one that will help you quit smoking

Tuesday, October 04, 2011

Did a Scrappy Little Startup Just Embarrass the FDA?

By Jan Gurley, MD

Adverse Events is a heath-tech start-up so new, they barely exist. Despite that, they’re getting some major results. This week they announced that they found from their early analysis – of the FDA’s own data – that two epilepsy drugs may be more dangerous in pregnancy than their FDA labeling might suggest. They used the FDA’s adverse event reporting data to compare the adverse events of commonly prescribed epilepsy drugs in pregnancy. What they found was that the FDA’s own labeling wasn’t consistent with their data.

Currently, the FDA classifies drugs used during pregnancy as being anywhere on a scale of safety from class A (“no known risk”), through levels of increasing risk labelled B, C, D, and then one final class X (“danger – do not use”). Specifically, Adverse Events found that two drugs, Lamictal and Keppra, which are Class C, may be “as dangerous to a fetus as drugs currently listed” in a more risky category (D).

In fact, Adverse Events’ analysis showed that an average birth defect rate comparison between the two groups, C and D, revealed no meaningful differences between the two. This scrappy little start-up’s analysis of the FDA’s own data may indicate that the FDA’s current categorization of pregnancy risks for epilepsy drugs may need revision. Or may be subject to bias.

I got a chance to talk to Adverse Events’ CEO, Brian Overstreet, at Health 2.0. We touched on some interesting controversies and future directions for this company.

Their provocative premise: Anyone should be able to report a side effect

Adverse Events has taken a new, e-patient approach to adverse events reporting by building in a feature that allows anyone to report their own experiences with side effects from their drugs. That process alone – allowing patients to report problems directly without being filtered through a doctor or drug company – already has some healthcare professionals feeling nervous. Overstreet thinks empowering patients is a huge issue in healthcare, and an important mission for their company. As he put it, “Disease groups have shown that people need a forum and want to share things with other people. Patients are coming to understand that they need to take it into their own hands to manage their conditions. When it comes to side effects, there is both a reluctance to report, and a sense that it will go into a void – if they report it to the FDA, they [the FDA] don’t do anything with it. Even what exists in the FDA’s database is only approximately 10% of what is happening each year. If we can improve that number even a bit – say 30% or 40% – that will be a big benefit to everyone.”

Adverse Events Interactions?

As a doctor, I wanted to know if there is going to be an adverse events “drug interaction” database? I think being able to plug drugs into an app, and find out if their adverse events are compounding each other, would be a great patient care tool. Overstreet explained that such a function “will be version 2.0. It’s a whole new level of math. Just getting and cleaning up the FDA database, we thought would take six months. It took 18 – that kind of adverse events interaction tool is definitely a stage II process.”

A Placebo Side Effects Profile

Every clinical trial ever done against placebo shows the reported placebo side effects. Surprisingly, there is not just a placebo benefit to people, there are also placebo side effects, such as headache and nausea. Sometimes the trials show that the difference between those reported side effects, and the ones for the drug, aren’t that different. I wanted to know if Adverse Events plans to include a placebo tab? Overstreet said no. Since their site is devoted to post-clinical trials experiences (where there is no placebo), they don’t have any plans to include reported placebo side effects for comparison.

Where Do They Go From Here

When it comes to post marketing drug side effect experiences, Overstreet said their first priority is bolstering the patient data beyond the FDA’s reporting, and grabbing the free-form data that is out there in patient chat rooms and groups. That is the most immediate stuff in the pipeline. The second is their approach to areas where the FDA has dropped the ball – as in epilepsy drugs in pregnancy, and statins, where the adverse events for one drug are clearly as common in others, but have prompted no label change. The second big pipeline issue is getting at the number of prescriptions written nationwide. They are currently getting their data from IMS, who get their data from pharmaceutical companies.

Post marketing trials are huge issue that the FDA and pharmaceutical companies are hashing out. Overstreet feels drug companies have to react strongly to any adverse event and the drug companies feel any type of reporting on their part becomes a regulatory issue. But, as he put it, “With our site, they can no longer bury their heads in the sand about this issue. Patients and providers and healthplans are going to now have this data, so they need to start dealing with this data.”

Trolling The Web For Adverse Events

Overstreet explained that one of the innovative approaches they plan to take toward getting adverse events information is by going to patient communities online, and trolling for mentions. He explains that the company is planning on refining this approach, and that, as a task, it is technically very feasible. “There are a lot of resources out there that provide the ability to go out there and look, and give you a dashboard of comments. The question becomes, if you have 1 million records to look at, how do you standardize that process?” Adverse Events plan on tackling that monumental task, and feel it is an important advance in patient safety over the current method, which, as Overstreet explained, “waits for a pharmaceutical company to have received a certain number of completed, full reports, at which point they are required to report it to the FDA. We believe those standards are too high. You don’t need to have the ‘end date’ of someone’s medication [to have a valid report].” According to Overstreet, the primary question they will need to tackle in going out to the web and looking for side effects boils down to “how do you take data that has an unstructured format and turn it into a structured format?”

What They’re Not Planning On Doing

I asked about the touchy issue of vaccines and autism, in terms of where this company stands on the issue of reporting associations that actually may not have any cause at all. In terms of deciphering out the difference between causation versus correlation, Adverse Event’s approach is to deal with this complex issue by a) the sheer scope of the data they have, and b) if a report comes into their database with a higher-than-normal reporting frequency, then it raises a red flag, which they then make public. As Overstreet put it, they don’t want to be arbiters of data, and if they see an issue raised, then they want it investigated.

Similarly, post-marketing trials of open-label drugs is also a scope of work that Adverse Events doesn’t plan on tackling in the immediate future. While there may be some therapeutic potential found for drugs buried in the data that they’ve cleaned and presented, Adverse Events doesn’t, at this time, see pursuing those possibilities as part of their mission.

Overstreet believes that their wealth of data “mutes out some outlier issues.” While they might be willing to work with researchers, and regulatory agencies to investigate issues, they do not plan on going to those groups first and waiting years for it to be sorted out. Like they’re showing with their reporting of pregnancy adverse events rates and anti-epilepsy drug inconsistencies, they instead plan on going straight to the press.

Jan Gurley is an internist physician who practices in a homeless clinic for the San Francisco Department of Public Health. She blogs at Doc Gurley: Posts from an Insane Healthcare System where this post originally appeared.

Nanoparticles make DNA analysis 1,000 times faster

Nanoparticles make DNA analysis 1,000 times faster
Nanoparticles make DNA analysis 1,000 times faster
(Nanowerk News) A University of Arkansas researcher has patented a process that reduces the time it takes to perform DNA analysis from hours to minutes. This development could contribute to many areas of health care and law enforcement, including diagnosing and treating disease, developing and testing new vaccines and forensic identification.
Donald K. Roper, associate professor of chemical engineering, explained that the ultimate goal of his research is to develop a credit-card-sized device to be used in a doctor's office or at a crime scene to quickly analyze samples of DNA. "That's the power of being able to do this on a really tiny scale," he said.
To analyze DNA, scientists must often make a tiny sample large enough to work with. To do this, they use a process called polymerase chain reaction, or PCR. Roper, who holds the Charles W. Oxford Endowed Professorship in Emerging Technologies, has invented a way to perform this reaction thousands of times faster than traditional methods.
Roper's process, which he developed while working at the University of Utah, uses gold nanoparticles to increase the efficiency of the chain reaction. During the reaction, strands of DNA are heated and cooled in cycles. When the samples are heated, the two strands of a DNA double helix come apart, and when the temperature is lowered, an enzyme called polymerase zips each strand to other, complementary strands, forming two new DNA helixes.
These copies are then heated and cooled again, doubling each time until the desired amount of DNA has been produced.
Roper's method reduces the time involved in these cycles from minutes to milliseconds, which means that a DNA sample could be analyzed within minutes rather than hours. By associating the DNA and enzyme with a gold nanoparticle and then exciting the nanoparticle with a light source or laser beam, Roper can target temperature changes to the area immediately around the DNA. This allows researchers to raise or lower the temperature more quickly. In addition, the process can be used to analyze the DNA during the reaction.
"We can use the laser light and the gold nanoparticles to do both the amplification and the analysis simultaneously," explained Roper. "The electromagnetic field around the nanoparticle is strong enough that it can sense whether or not the strand that we're interested in is there. The laser induces the field and then a detector assays the difference in the field."
Roper's research has implications for many scientific fields. "Genomics underscores everything of interest to biology: gene sequencing, disease diagnostics, pharmaceutical development and genetic analysis," he explained. "DNA is the basis of inheritance for the cell, and the degree of transcription of the DNA determines how a cell will function. This is a tool that examines these processes."

Source: University of Arkansas, Fayetteville