Off-Label Drug promotions are not likely to be caught by the FDA

A new government study performed by the Government Accountability Office, detailed here at FDA News, states that if a company has off-label drug violations, they are unlikely to be caught by the FDA. The FDA issued 42 letters to companies between 2003 and 2007, but none of these cases reached the Justice Department. The eleven cases that were settled by the Justice Department were brought to the court by someone other than the FDA.

The article concludes by saying that the FDA doesn’t have an organized system that makes the FDA’s system unlikely to find off-label violations.

Medical Malls

Running late at the mall and still need to fit in a physical? No problem, according to this article, in Prince George’s County in Maryland, you can stop by the doctors office while shopping. Officials said that they made the decision to provide these services since there was no foreseeable downside. Some of the positives include generation of jobs, and tax revenue as well as increased access by the public to medical services. Individuals from less advantaged neighborhoods previously may not have always been able to go see the doctor, but with this new service, accessibility would be increased. As the Washington Post reports:

Under the plan, the county would partner with private retail owners to renovate or build spaces where customers could, for example, buy a pair of shoes in one end of the mall and get a mammogram or a physical in another. The partnership would be paid for with public and private dollars.

While to some this may seem like a novel idea, it has been around for 20 years, with approximately 50 “medical malls” currently across the U.S. What are you opinions for this interesting concept in health care? Do you think that this will catch on and become a new trend?

Falls Among Elderly is a Big Concern

This article in the NY Times details that even though injuries from falls in people over 65 do not seem serious at times, many complications such as rhabdomyolysis, which causes kidney failure, can arise from such falls. In the article, an 88 year old woman was admitted into the hospital after falling and lying on the floor for more than 15 hours. Even though there was no bruising or visible injuries, by lying in her bedroom floor for so many hours with her legs pinned beneath her, her muscle cells became inflamed.

A solution that prevents kidney failure in rhabdomyolysis is sodium bicarbonate infusions, but the problem is that treatment could overwhelm the heart of a senior citizen by building excess fluid in the lungs which can prove to be fatal. According to the Centers for Disease Control and Prevention, falls are the leading cause of death from injury among people over 65. Relatives and friends should inspect the homes of seniors for slippery surfaces and other fall-inducing conditions regularly to prevent falls from occurring.

Mail-In prescriptions on the rise

Medco, one of the major suppliers of mail-in prescription drugs, is seeing a huge benefit to increased gas prices: more customers. Medco sites fewer people paying for gas to drive to the pharmacy have lead to an increase in their sales, which shows increased revenue of 27% leading profits to $5.45 billion. In the second quarter of 2008, earnings increased 12% and they dispensed 26.3 million prescriptions according to this blog at the Wall Street Journal. However, with the poor economy, they point out that are also loosing a high volume of patients, because as companies lay off their workers in this economic slump, they are loosing people paying for their prescriptions.

Trans Fat Ban in California

It is a historic day in the fight against trans fat. This article from abchealthnews.com announced that Arnold Schwarzenagger, has just signed into law today a ban against trans fats in California. As announced in this separate article from Harvard School of Public Health, Mayor Michael Bloomberg of New York City, was responsible for making New York City the first city to ban trans fats in all restaurants. He was a recipient of the Richmond Award for promotion of public health, for his proactive stand. In fact, as announced here, July 1^st 2008, marked the completion of the final phase for restaurants in the city to comply to the zero trans fat policy.

What makes the case in California special is that it is the first state in the nation to pass the legislature on such a large scale. While the U.S. is still lagging in terms of making the ban on trans fat a nationwide policy, with the example of California it will interesting to note if the rest of the country follows suit. Also of potential interest, while there is not much text on the role insurance providers play on trans fat legislation, it might be something to see if they will start lobbying Washington for this change.

Bill Gates and Michael Bloomberg Team Up For New Anti-Smoking Effort

According to this latest article in the NY Times, the World Health Organization estimates that tobacco will kill about a billion people in the 21^st century, which is 10 times as many people that it killed in the 20^th century. Most of the deaths are expected to come from poor countries like Bangladesh and middle-income countries like Russia. The Bill and Melinda Gates Foundation has partnered with the Bloomberg Foundation to spend a total of $500 million to stop people around the world from smoking.

Mr. Bloomberg mentions:

“All the money in the world will never eradicate tobacco, but this partnership underscores how much the tide is turning against this deadly epidemic.”

The campaign, named Mpower, will urge governments to prohibit smoking in public places, raise tobacco taxes, start anti-smoking ad campaigns, outlaw tobacco advertising to children, and offer nicotine patches in order to help people quit. Other countries like India and China who have begun anti-smoking ad campaigns in the past have are experiencing an increasing number of people who have quit smoking. The $500 million will be allocated over a time span of 5 years.

Study finds Epilepsy Drug Harmful to Pregnant Women

In a recent study, detailed here in the LA Times, doctors in the UK found that women taking Topiramate, sold in the US by Johnson and Johnson under the name, Topomax, can lead to serious birth defects if the users are pregnant when taking the drug. Topiimate is a common drug used to control seizures and often given to those who suffer from migraines. Of the 203 women tested, it was found that chances for a birth defect was increased by 14-fold.

Of the 203 pregnancies in the test, there were two still births, five induced abortions, and 18 pregnancies that ended in spontaneous abortions. Of the 178 babies born, there were also 16 infants who suffered from major birth defects.

Doctors current suggestions for users was to stop taking the drug if the use is for treating migraines, but continue to use the drug if epilepsy is the reason for use, as seizures be harmful to the fetus.

Jalapeno Linked with Salmonella Outbreak

We have been keeping you up to date with information on the salmonella outbreak as with this recent post on our blog. In latest news concerning this subject, the FDA has found the same rare strain of salmonella on a jalapeno pepper that was grown in Mexico and stored in a Texas warehouse. According to this article from the San Francisco Chronicle this is the first piece of produce that has the matching strain of bacteria. Despite this lead the FDA still recommends caution saying that “the ultimate source of the contamination has yet to be found” even though last week they did claim that it was safe to eat tomatoes.

As Tom Nassif, chief executive for Western growers stated

"It's a great relief to know it's not tomatoes, even though the CDC (federal Centers for Disease Control and Prevention) and the FDA will never admit it wasn't tomatoes,"

Dr. David Acheson, FDA associate commissioner in charge of the investigation believes, however that

“during the initial outbreak - where cases were found as early as April 10 - there was a ‘clear association’ with consumption of fresh tomatoes. Only later were peppers clearly implicated, as well. “

Meanwhile California is bracing itself for another economic blow since they produce approximately $45 million worth of jalapeno peppers a year. They already suffered some setback in the form of a 40% decline in their tomato market.

US Healthcare Failing Nation

In a recent article at the Washington Post, they report on the failing grade the US health care system received last year. Although the health care in the US hasn’t improved since 2006, the US spends more on health care than any other nation. In 2003, 35% of Americans had no health insurance. In 2007, this number had risen to 42%. The quality of health care was also dramatically different from state to state, and region to region.

The scores of efficiency rated among the lowest of variables. Some of the reasons were:

-Fragmented, poorly coordinated care
-Lack of access that leads to avoidable hospitalizations
-Variations on costs with no return in quality
-Lack of investment in IT
-High insurance overhead costs

Cathy Schoen, the senior vice president for research and evaluation at the Commonwealth Fund had this to say of the situation:

“Overall, we find a failure to improve, with steep declines in access with growing numbers of uninsured and underinsured and ever less affordable care. Overall, the U.S. score averages just 65 out of a possible 100, falling far short of benchmarks with wide gaps in all dimensions of the health system.”

Healthy Dieting: Beyond Weight Loss

According to this article in the NY Times, a study conducted at the Nuclear Research Center in Dimona, Israel followed the patterns of 322 dieters, both men and women, on three different types of diets- a low-fat diet, a Mediterranean diet; and a low-carb diet based on the Atkins diet plan.

By the end of the two year study low-fat dieters had a net loss of six pounds, and the Mediterranean and low-carb dieters had a net loss of about 10 pounds. Even though weight loss was modest, researchers claimed that there were noticeable improvements in cholesterol and other health indicators. Iris Shai, the study’s lead author mentions:

“This suggests that healthy diet has beneficial effects beyond weight loss.”

Intel Health Guide

According to this article on eWeek, a small touch screen PC that includes a new online interface released by Intel that allows patients to connect with their doctors has won approval by the FDA.

The Intel Health Guide will be able to handle a series of patient care services. The system will take the burden away from insurance companies, since the monitoring of patients with chronic and outgoing patients will be done at home instead of the hospital.

Louis Burns, VP and general manager of Intel's Digital Health Group mentions:

"With more people living with chronic diseases, we believe care can be increasingly moved outside of the hospital to the home. Through our research, we've learned that a home-based model of care becomes more than just delivering care to patients at home—it is about creating connections to family, friends, caregivers, and the care team."

Glucose monitors, blood pressure monitors, and other medical devices can be attached to the Intel Health System, and the information gathered can be shared with doctors on the Internet through a secure host server. We can expect the Intel Health System to reach the US market by end of 2008 or by the first quarter of 2009.

Deaths of Infants in Argentina blamed on influenza vaccine

Pharmalot reports that a clinical trial for a pneumonia vaccine in Argentina by GlaxoSmithKline has resulted in the death of twelve infants. There were 15,000 infants who participated in this trial. The article states that the majority of the participants came from underprivileged familes, who could not read the consent form at the time of the agreement. Pneumonia is the leading cause of death in infants from infectious diseases and results in the death of two million children around the world under the age of five.

GlaxoSmithKline pointed out: the infant post-neonatal mortality rate of children participating in the COMPAS study does not exceed the post-neonatal mortality rate in the countries participating in the study.

Obesity in the Maternity Ward

Over the past couple of decades, we have seen the obesity epidemic spread through every demographic group, but now according to this article in the NY Times, 1 out of every 5 women who give birth in the U.S. is obese, ranging from 400 to sometimes 600 pounds. Pregnancy is made riskier with this excess weight, and obese women are more likely to develop diabetes, hypertension, and to deliver prematurely. Dr. Mark Chames, an obstetrician at the University of Michigan Health System at Ann Arbor, has directed a new center for Bariatric Obstetric Care to address this problem.

New treatment and procedures are needed in care for obese women. For example, an ultrasound signal can not penetrate through the tissue so instead Dr. Chames uses a vaginal probe. Weight loss is even encouraged in this center, as evidence suggests that women who maintain or lose weight during pregnancy experience fewer complications and deliver healthier babies. Still, much more research is needed to make this approach more popular in other hospitals.

Latest Update in Salmonella Outbreak

In this post on July 2, we brought you information stating that the salmonella outbreak may not have been caused by raw tomatoes as was first thought. Since then it has come to light, according to this report from MSNBC, that jalapeno peppers are another potential culprit that has come under investigation from the CDC

This has been one of the largest outbreaks, with over 1,000 reported cases, in recent history. Since May, it has been determined that the outbreaks occur in clusters of individuals across the country that have eaten foods containing both raw tomatoes and jalapenos. As a result, Dr. Robert Tauxe, from the CDC, made this statement:

“We are quite sure that neither tomatoes nor jalapenos explain the entire outbreak at this point. ... We’re presuming that both of them have caused illness,” Tauxe said.

Meanwhile the economic toll totals over $100 million in losses for the tomato industry alone. Industry wide totals for other affected foods like jalapeno and cilantro have not yet been calculated.

Improvements in IVF

As reported in this article from BBC News Health, there may be a chemical “fingerprint” that can help doctors determine which embryos will implant more successfully for IVF patients by as much as 15%.

Scientists from Yale created the ViaTestE which scores the metabolic activity of some of the fluid surrounding the embryo with spectrophotometry. In a research trial testing this new way in comparison to traditional methods, it was found that the accuracy of ViaTestE is between a 60% and 70%, while currently there is only a 40% accuracy rate

This is especially helpful since doctors are trying to head in the direction of just implanting one embryo instead of multiple. Dr. Daniel Brison, co-director of North West Embryonic Stem Cell Centre had this important thought

"If we can get better at choosing the best embryo to implant then we can increase the efficiency of IVF, move towards single embryo transfers and thus reduce the risk to mothers and babies."

Health Care Concerns

The main theme discussed in this post on The Healthcare Blog seems to be that consumers are more concerned about the cost of healthcare than the illness itself. Most Americans are often confused when given many choices of insurance providers to shop for. Consumers aren’t used to shopping for insurance, and so it can be quite troublesome.

A survey conducted by McKinsey also found that there are also differences in health concerns varying by age. Younger people aged 18-34 are far more concerned with dental and accidents, whereas older people are more worried about LTC and major medical events. There is still a long way to go in the health care system when fighting costs is a major concern over fighting diseases.

Link Found Between Serotonin and SIDS

LA Times reported in this article about a study conducted by Dr. Cornelius Gross, author and head of the European Molecular Biology Laboratory in Monterotondo, Italy, which shows that there may be a link between serotonin and sudden infant death syndrome (SIDS). Scientists made a statement to the journal, Science, that mice who were genetically altered to produce excess serotonin died young with similar symptoms to human infants who have passed away from SIDS. The initial study was conducted to determine how serotonin affects aggression and anxiety, and as Dr. Gross stated about the results, “This was a chance discovery.”

Dr. Gross also hopes that his study will lead other researchers to "to devise diagnostic tests to try to identify those kids most likely to . . . die of SIDS." His findings have already been supported by Dr. Hannah Kinney who in 2006 had conducted a study regarding abnormal serotonin production in infants who died of SIDS.

In addition, Dr. Gene Nattie, a colleague of Kinney, and professor of physiology at Dartmouth Medical School remarked "The main impact is if you produce a very specific deficit in the serotonin system, you get a disastrous result. That's why the paper is important. It's certainly a big step forward."

Cholesterol Screening at an Earlier Age

This recent article in the NY Times points out that pediatricians are beginning to recommend aggressive cholesterol screening for children as early as eight years old. Many experts claim that signs of heart disease show up early in kids, especially when 30 percent of the nation’s children are obese and overweight.

Previously, cholesterol lowering drugs were recommended for children above the age of 10, and only if they fail to lose weight during a 6-12 month period. But now according to the American Academy of Pediatrics, cholesterol drugs might be our youth’s best hope in preventing heart disease. Screenings are highly recommended for those who have a family history of high cholesterol levels. Even though children will now undergo drug treatment at an earlier age, the first goal will still be to lower bad cholesterol through diet and a rigorous exercise program.

FDA Urges Longer Testing Periods for Diabetes Drugs

The NY Times reports in a recent article that Diabetes drugs must face tougher safety standards that protect patients from heart risks associated with these drugs. The FDA has voted 14-2 to prolong trial study time to assure that diabetic drugs do not carry risks of heart problems.

This concern on diabetic drugs came about shortly after the FDA was criticized for handling the release of the GlaxoSmithKline pill. The drug was released in 1999, but only last November was a warning issued about potential heart risks. The problem lies in the testing phase; it takes nearly five to seven years to complete. Studies should begin way before drugs are submitted to the FDA, and finished shortly after its release.

Tainted Tomatoes May not be Cause of Salmonella Outbreak

Two weeks ago we posted on this blog about tainted tomatoes causing a salmonella outbreak. Several news sources, including the Wall Street Journal in this article, have announced that the FDA and the CDC are now saying that they are unsure if tomatoes are truly the culprit. Officials have expanded their investigation, to include other foods, since it is estimated that in only 80% of the 869 reported cases of salmonella poisoning people consumed tomatoes. Many of these individuals reported eating tomatoes that were incorporated into dishes such as salsa, and guacamole which are composed of numerous other raw foods. While tomatoes are still the main suspected cause, the FDC and CDC are looking at other foods such as cilantro which is often eaten in conjunction with tomatoes.

In related news the economic impact of this food scare is estimated at over $250 million according to Donna Garren, vice president of health and safety regulatory affairs for the National Restaurant Association. With other food items coming into focus the financial blow is only going to increase.

Good Cholesterol Improves Memory

The NY Times reports today that higher levels of good cholesterol, known as HDL, might prevent a decline in memory loss. The study led by Archana Singh-Manoux, appears in Arteriosclerosis, Thrombosis and Vascular Biology, an American Heart Association Journal, found that people with more high-density lipoprotein cholesterol did better on memory tests than people with lower levels.

The study was performed on more than 3,600 British civil servants ranging from 55 to 61 years of age. The test consisted of reading a list of 20 words, and then jotting down as many as they could remember in a span of two minutes. Those with higher HDL levels performed better and those whose HDL levels declined also saw a decline in their performance.