Tuesday, April 24, 2012

Teens Getting Drunk On Liquid Hand Sanitizers

Editor's Choice
Main Category: Pediatrics / Children's Health
Also Included In: Alcohol / Addiction / Illegal Drugs
Article Date: 24 Apr 2012 - 19:00 PDT

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Los Angeles emergency rooms are reporting a growing number of teenagers coming in drunk after drinking cheap liquid hand sanitizer. The hand sanitizers, which contain over 60% ethyl alcohol and can make a 120-proof liquid, are becoming an increasingly popular route for getting drunk.

According to the Los Angeles Times, six teens have been reportedly taken to emergency rooms in the San Fernando Valley and treated for alcohol poisoning after drinking the hand sanitizers.

In some cases, salt was used to separate the alcohol, so that it could be drunk straight, like a shot.

Learning how to distill the sanitizer is not so difficult if you know how to look things up online.

Public health officials in the San Fernando Valley have described these cases as possibly a signal of a dangerous trend.


A bottle of alcohol gel - no label
Alcohol-based liquid hand sanitizer


Cyrus Rangan, director of the toxicology bureau for the county public health department, said to the Los Angeles Times:

"All it takes is just a few swallows and you have a drunk teenager. There is no question that it is dangerous. It is kind of scary that they go to that extent to get a shot of essentially hard liquor (use salt to separate the alcohol)"

Rangan wonders whether these possibly isolated cases might eventually turn into a problem for the county. These hand sanitizers are relatively cheap, and well within the budgets of the majority of teenagers.

Health officials say that there had been cases of younger children accidentally consuming hand sanitizer.

Doctors say this practice of using hand sanitizer liquid to get drunk is new - last year there were no reported cases in the area.

Health officials say it is important for parents to understand how much alcohol these products contain - even a small bottle has enough to get drunk on, because the alcohol content is highly concentrated.

Foam versions are probably safer if there are children in the house, officials say. Foam is much harder to separate the alcohol from.

Written by Christian Nordqvist
Copyright: Medical News Today
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Monday, April 23, 2012

Migraines - Many Treatments Work, But Few Use Them

Editor's Choice
Academic Journal
Main Category: Headache / Migraine
Article Date: 23 Apr 2012 - 21:00 PDT

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Although several preventive migraine treatments are very effective for many patients, few sufferers use them, according to new American Academy of Neurology guidelines. The guidelines have been published in the journal Neurology and will be presented tomorrow at the American Academy of Neurology's 64th Annual meeting in New Orleans.

Author Stephen D. Silberstein, MD, FACP, FAHS, of Jefferson Headache Center at Thomas Jefferson University in Philadelphia and a Fellow of the American Academy of Neurology, said:

"Studies show that migraine is underrecognized and undertreated. About 38 percent of people who suffer from migraine could benefit from preventive treatments, but only less than a third of these people currently use them."

Preventive treatments are generally administered daily to prevent migraine attacks from ever occurring, or to lessen their severity and length of duration if they do.

Silberstein said:

"Some studies show that migraine attacks can be reduced by more than half with preventive treatments."

All evidence related to migraine prevention was reviewed before the guidelines were made.

Prescription Medications For Migraine Sufferers

The following prescription medications were found to be effective in preventing migraine attacks, or at least reducing their severity and/or duration:
  • divalproex sodium (an seizure medication)
  • sodium valproate (an seizure medication)
  • topiramate (an seizure medication)
  • metoprolol (beta blocker)
  • propranolol (beta blocker)
  • timolol (beta blocker)
The guidelines say that doctors should offer these medications for the prevention or reduction in frequency or severity of migraine attacks.

The guidelines say that Lamotrigine, a seizure medication, does not prevent migraine.

Over-The-Counter Medications

According to the guideline, herbal preparation Petasites (butterbur) can effectively prevent migraine attacks.

The following were also found to be effective:

    NSAIDs (nonsteroidal anti-inflammatory drugs)
  • Fenoprofen
  • Ibuprofen
  • Ketoprofen
  • Naproxen and naproxen sodium
  • Subcutaneous histamine

  • Complementary treatments
  • Magnesium
  • MIG-99 (feverfew)
  • Riboflavin
Even though patients do not require a prescription for these OTC medications and complementary therapies, Dr. Silberstein said that patients should still visit their doctor for their scheduled follow-up appointments.

Silberstein said:

"Migraines can get better or worse over time, and people should discuss these changes in the pattern of attacks with their doctors and see whether they need to adjust their dose or even stop their medication or switch to a different medication. In addition, people need to keep in mind that all drugs, including over-the-counter drugs and complementary treatments, can have side effects or interact with other medications, which should be monitored."

Written by Christian Nordqvist
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American Lung Association New Guidance On Lung Cancer Screening

Editor's Choice
Main Category: Lung Cancer
Article Date: 23 Apr 2012 - 19:00 PDT

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In the United States, lung cancer kills more people than any other cancer and has a five year survival rate of only 15%. With that in mind, the American Lung Association released updated guidelines on screening for lung cancer, based on research from the National Cancer Institute National Lung Cancer Screening Trial (NLST).

The NLST has found in its recent work that low-dose computed tomography (CT) reduced lung cancer deaths by up to 20%, when compared to standard chest X-Rays. The NLST findings have already been put into effect to some extent, but The American Lung Association's Lung Cancer Screening Committee, chaired by Jonathan Samet, M.D., M.S., from the University of Southern California, highlights this information to both the public at large and the physicians treating them.

The Lung Association recommends that those between the ages of 55 and 74, with a history of smoking to a level of 30 pack years (that is a pack a day for 30 years), whether they have a history of lung cancer or not, should be screen with CT scans. There are unknown risks associated with the CT screening.

Edelman, M.D., chief medical officer of the American Lung Association reminds that :

"Never starting smoking and quitting smoking still remains the best way to prevent lung cancer .. Additionally, it is also important for people to have their homes tested for radon, as radon exposure can increase the risk of lung cancer."

The report also reminds medical centers to refer patients to specialist facilities that can better undertake and diagnose the CT scans, and also promote and advertise the option of lung cancer screening for long term smokers to patients.

The American Lung Association says it hopes to save lives with its new strategy and vows to continue to fight for clean air and reduced tobacco smoking.

Written by Rupert Shepherd
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Thursday, April 19, 2012

26% Of Working Age Adults In USA Lack Health Insurance

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Main Category: Health Insurance / Medical Insurance
Article Date: 19 Apr 2012 - 18:00 PDT

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Just over one quarter (26%) of all Americans of working age in 2011 experienced a gap in health insurance cover, says a new report published by the Commonwealth Fund. The authors explained that in many cases, when people change their jobs or become unemployed, many of them lose health coverage.

It can be extremely difficult to recover employer-sponsored health coverage after it is lost, the report showed. 69% of those who spent time with no health insurance, did so for at least 12 months; for 57% the period was longer than two years.

The data, which is based on the 2011 Commonwealth Fund Health Insurance Tracking Survey of U.S. Adults, showed that among those who had no insurance when the survey took place, 41% reported having had employer-sponsored coverage. 67% of individuals who lost their employer-sponsored coverage said the main reason for their loss of coverage was a loss or change of employment.

Many cannot find affordable insurance coverage on their own

The report, entitled "Gaps in Health Insurance: Why So Many Americans Experience Breaks in Coverage and How the Affordable Care Act Will Help", explained that purchasing coverage on their own is either not an option, or extremely hard for a large number of people of working age.

The authors found that:

  • 62% of individuals who attempted to purchase individual health insurance during the past 36 months found it either extremely hard or impossible to find affordable policies

  • 31% applied for health insurance coverage and were turned down, charged a higher price, or excluded because of some pre-existing condition

  • 60% of those who attempted to buy a plan on their own reported that it had been very or somewhat difficult to properly compare the benefits offered by different plans

  • 45% said they did not purchase a plan, the main reason being the high costs involved
Lead author, Sara Collins, Commonwealth Fund Vice President, said:

"For people who lose employer-sponsored coverage, the individual market is often the only alternative, but it is a confusing and largely unaffordable option. As a result, people are going a year, two years, or more without health care coverage, and as a result going without needed care."

Long insurance gaps associated with lower screening and preventive care rates

92% of those of working age who had continuous health insurance coverage said they had a regular doctor, compared to 76% among those with a coverage gap of up to 12 months, and 46% for those with longer coverage gaps.

Preventive cancer screening rates were much lower among those with coverage gaps, compared to insured people; the differences became larger the longer individuals had no health insurance.

Cholesterol checks - 70% of people with continuous insurance had had their cholesterol checked during the previous five years, versus 50% among individuals with a coverage gap of less than 12 months, and 33% for those with longer coverage gap periods.

Mammograms - 74% of women of working age with insurance had received a mammogram during the previous 24 months, versus just 28% among those with a coverage gap of at least 12 months.

Blood pressure - 83% of those with continuous health insurance had had their blood pressure checked during the previous 12 months, compared to 70% among individuals with a coverage gap of less than 12 months, and 51% for those with longer coverage gaps.

Authors say the Affordable Care Act is having an impact

The authors explain that the Affordable Care Act is already closing the large difference in the USA between the "haves" and the "have nots" regarding healthcare coverage. An example is the provision for dependent coverage that was introduced in 2010 - offspring up to the age of 26 years became eligible to remain on their parents' health insurance plan.

46% of 19 to 25 year-olds reported staying or joining their parents' insurance policy over the last 12 months. 23% of adults with children under 26 said they had an adult offspring remain on or enroll in their health plan.

However, the authors stressed that higher-income families appear to have taken advantage by this new option in much higher numbers than low-income ones. Probably because better-off families are more likely to already have health insurance, which can then be extended to their adult children.

Karen Davis, Commonwealth Fund President, said:

"The current system of health insurance in the United States has gaping holes, the effects of which have become increasingly pronounced during a weak economy. The Affordable Care Act is beginning to close those gaps, so that people who are already struggling can maintain health care coverage that will provide for their families' health and help ensure their financial security."

Written by Christian Nordqvist
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Wednesday, April 18, 2012

Despite Encouragement Some Patients Do Not Walk After Surgery

Editor's Choice
Main Category: Women's Health / Gynecology
Article Date: 18 Apr 2012 - 13:00 PDT

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After undergoing surgery, some patients are reluctant to walk, despite the encouragement of medical staff, even though the benefits of doing so are well-documented.

In order to determine whether a program that encourages patients to walk had a positive effect, researchers from Loyola University Health System conducted a study, involving 146 patients, who underwent gynecologic surgery who either had routine care with no encouragement to walk, or a goal-oriented walking program following surgery.

Findings from the study were presented at the prestigious 38th Annual Scientific Meeting of the Society of Gynecologic Surgeons in Baltimore.

The researchers found that patients who received care without encouragement took a median of 87 steps, patients who received encouragement took 80 steps, and 12% of patients did not walk at all.

Maike Liebermann, M.D., co-researcher, LUHS, explained:

"There are many obstacles that can prevent a patient from moving after surgery. If a patient cannot walk, this can increase the risk of complications and prolong recovery time and length of hospital stay."

Catheters or drains, pain, IVs, hospital gowns, and lack of assistance are all obstacles to walking. The researchers found that pain management, as well as early discontinuation of catheters and IV fluids have the potential to increase walking and overall outcomes for patients after surgery, although more research is required.

The researchers measured the amount of steps taken, using a pedometer, in the 24 hours before a patient was discharged from the hospital. Patients assigned to a goal-oriented walking program after surgery were encouraged to take at least 500 steps prior to discharge.

Michael Awad, M.D., co-researcher of the study, LUHS, explained:

"This was the first study to measure walking after surgery in gynecologic patients. It demonstrated an easy way for doctors to evaluate a patient's ability to walk and decide if the patient is ready to go home from the hospital."

The majority of patients are required to walk after surgery and prior to hospital discharge, although there is no guidelines to determine the adequate amount of walking after surgery.

The researchers conclude that additional studies need to be conducted in order to establish standards for walking after gynecologic surgery and that one consideration may be to treat walking as a vital sign so that it is regularly reported.

Additional authors included Megan DeJong, MD; Colleen Rivard, MD; Jim Sinacore, PhD; and Linda Brubaker, MD, MS.

Written By Grace Rattue
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Opium Usage Almost Doubles Death Risk

Editor's Choice
Academic Journal
Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Pain / Anesthetics
Article Date: 18 Apr 2012 - 18:00 PDT

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People who use opium have a considerably higher risk of dying from any cause, especially from cancer, respiratory conditions, and circulatory disease, researchers from Tehran University of Medical Sciences, Tehran, Iran, reported in the BMJ (British Medical Journal). The authors wonder what the long-term health risks might be for patients prescribed opioids for chronic pain treatment.

This study was performed in northern Iran, where the consumption of opium is very common. The researchers say that this is the first study to compare death risk among opium users versus non-users.

Approximately 20 million individuals globally use opium derivatives or opium itself. Previous studies have suggested that opium might raise the risk of developing bladder and throat cancers, coronary heart disease, as well as some other conditions and illnesses. However, not much has been known about opium's effect on overall mortality, especially long-term low-dose usage.

An international team of researchers set out to find out whether opium usage might be linked to subsequently higher death risk.

They gathered data on 50,045 adult males and females over a period of five years. They were all from the Golestan Province, northern Iran, and were aged from 40 to 75 years.

17% (8,487) of them said they used opium, for an average of 12.7 years. During the study period 2,145 deaths were reported.

The authors found that opium usage was associated with an 86% greater risk of death from several causes, including asthma, COPD (chronic obstructive pulmonary disease), TB (tuberculosis), cancer and circulatory diseases. They reached this figure after taking into account several factors that also drive mortality numbers, including poverty and tobacco smoking.

In a communiqué, the BMJ wrote:

"Even after excluding those who self-prescribed opium after the onset of a chronic illness, the associations remained strong and a dose-response relationship was seen."

All different types of opium were associated with higher mortality, including ingestion and smoking.

The authors say that about 15% of all deaths in this sample population are linked to opium usage, assuming that this represents a causal association. Further studies are required to look into what impact long-term opioid analgesics might have on mortality among patients being treated for chronic pain.


Slaapbol R0017601
Opium (lachryma papaveris) is the dried latex obtained from the opium poppy (Papaver somniferum)

Editorial in the same journal

Doctors in highly industrialized nations rarely ever come across patients who use opium, Assistant Professor Irfan Dhalla from St Michael's Hospital in Toronto, explained in a linked Editorial. However, millions of patients in chronic pain have been prescribed opioid analgesics, such as codeine and morphine. These painkilling medications, when taken over the long term, carry risks that "are incompletely understood".

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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"Opium use and mortality in Golestan Cohort Study: prospective cohort study of 50'000 adults in Iran"
Hooman Khademi, Reza Malekzadeh, Akram Pourshams, Elham Jafari, Rasool Salahi, Shahryar Semnani, Behrooz Abaie, Farhad Islami, Siavosh Nasseri-Moghaddam, Arash Etemadi, Graham Byrnes, Christian C Abnet, Sanford M Dawsey, Nicholas E Day, Paul D Pharoah, Paolo Boffetta, Paul Brennan and Farin Kamangar
BMJ 2012; 344 doi: 10.1136/bmj.e2502 (Published 17 April 2012) Please use one of the following formats to cite this article in your essay, paper or report:

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'Opium Usage Almost Doubles Death Risk'

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Swallowing Exercises Help Head And Neck Cancer Patients, Short-Term

Editor's Choice
Main Category: Cancer / Oncology
Article Date: 18 Apr 2012 - 13:00 PDT

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The April issue of Archives of Otolaryngology - Head & Neck Surgery reports that patients who undergo chemoradiation therapy (CRT), who perform specific swallowing exercises after their CRT, experience a short-term improvement in swallowing. The study also reveals that after nine or twelve months of treatment, there was no substantial difference in swallowing function amongst patients of the intervention and the control group.

Background information of the article states:

"With improvements in swallowing function from post-treatment exercises, interest in the use of prophylactic swallowing exercises to prevent or minimize post-CRT swallowing dysfunction has grown. Indeed, some cancer treatment centers recommend prophylactic swallowing exercises for all their patients undergoing CRT."

In a randomized, controlled trial, Tamar Kotz, M.S., C.C.C.-S.L.P., of the Mount Sinai Medical Center in New York, and her team examined 26 patients with head and neck cancer who were receiving CRT. The team randomized 13 patients to the intervention group who performed five specific swallowing exercises throughout their CRT and participated in weekly swallowing therapy sessions, whilst the other 13 patients, i.e. the control group received no swallowing exercises and were referred for swallowing treatment after completion of CRT, if suggested.

The team discovered no statistically important differences in swallowing scores on the Functional Oral Intake Scale (FOIS) between both groups immediately after CRT, nor did they observe any statistically important differences in Eating in Public subscale scores between both groups.

They did, however, note at 3 and 6 months after treatment, that those in the intervention group displayed substantially better scores on both scales, whilst the scores between both groups at 9 and 12 months after treatment proved no longer important. The authors remark that this could be because of the study's small sample size and conclude:

"Continued study with a larger sample size is needed to expand on these findings and provide a more powerful analysis of the effect of prophylactic swallowing exercises on patients with HNC [head and neck cancer] treated with CRT."

Written By Petra Rattue
Copyright: Medical News Today
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"Prophylactic Swallowing Exercises in Patients With Head and Neck Cancer Undergoing Chemoradiation"
Tamar Kotz, MS, CCC-SLP; Alex D. Federman, MD, MPH; Johnny Kao, MD; Lyudmila Milman, RPAC; Stuart Packer, MD; Coral Lopez-Prieto, BS; Kevin Forsythe, MD; Eric M. Genden, MD
Archives of Otolaryngology, April 2012, doi:10.1001/archoto.2012.187 Please use one of the following formats to cite this article in your essay, paper or report:

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Tuesday, April 17, 2012

Bevacizumab Doesn't Improve Survival In Some Older Lung Cancer Patients

Editor's Choice
Main Category: Lung Cancer
Also Included In: Cancer / Oncology
Article Date: 17 Apr 2012 - 12:00 PDT

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A study published in the April 18 issue of JAMA, reveals that Medicare insured non-small cell lung cancer (NSCLC) patients aged 65+, who received bevacizumab, in addition to the standard chemotherapy regimen carboplatin and paclitaxel, did not have improved survival compared to patients who received carboplatin and paclitaxel alone.

The findings of the study were presented by Deborah Schrag, M.D., M.P.H., of the Dana-Farber Cancer Institute, Boston, at a JAMA media briefing at the National Press Club.

Bevacizumab was approved by the U.S. Food and Drug Administration for the treatment of NSCLC in 2006.

The researchers said:

"A previous randomized trial demonstrated that adding bevacizumab to carboplatin and paclitaxel improved survival in advanced non-small cell lung cancer (NSCLC). However, longer survival was not observed in the subgroup of patients aged 65 years or older.

Notwithstanding the uncertainty about benefits in the population aged 65 years or older, the Centers for Medicare & Medicaid Services (CMS) has covered bevacizumab therapy for its enrollees subsequent to Food and Drug Administration (FDA) approval.

Little is known about how clinicians have interpreted efficacy studies to formulate treatment recommendations, and give that approximately two-thirds of patients with lung cancer receive their diagnosis at age 65 or older, establishing the survival advantage of bevacizumab in the Medicare population is a priority for informed decision making."

In order to determine whether bevacizumab in addition to carboplatin-paclitaxel was linked to improved survival in the Medicare population, Dr. Schrag and her team conducted a study involving 4,168 Medicare beneficiaries aged 65+ with advances (stage IIIB or stage IV) non-squamous cell NSCLC diagnosed in 2002-2007.

The team used analytic strategies in order to address confounding and selection bias caused by the lack of treatment randomization in observational studies that may limit the ability to make valid inferences about causality.

Based on year of diagnosis and type of initial chemotherapy administered within 4 months of diagnosis, the team categorized patients into three cohorts:

  • Diagnosis in 2002-2005 and carboplatin-paclitaxel therapy.

  • Diagnosis in 2006-2007 and carboplatin-paclitaxel therapy.

  • Diagnosis in 2006-2007 and bevacizuman-carboplatin-paclitaxel therapy.
The team used various models and analyses, in order to compare overall survival and the associations between carboplatin-paclitaxel along or in addition to bevacizumab.

For patients receive carboplatin-paclitxael in 2006-2007 and 2002-2005 the team found that median overall survival was 8.9 months, and 8.0 months respectively, compared with 9.7 months for those receiving the bevacizumab combination.

One-year survival probabilities were:

  • 40.1% for carboplatin-paclitaxel in 2006-2007

  • 35.6% for carboplain-paclitaxel in 2002-2005

  • 39.6% for bevacizumab-carboplatin-paclitaxel in 2006-2007
Controlling for demographic and clinical characteristics in adjusted models, the researchers found no considerable difference in overall survival between the three cohorts.

According to the researchers, the 4 propensity score-adjusted models showed no evidence that bevacizumab-carboplatin-paclitaxel was superior to carboplatin-paclitaxel. In addition, the researchers found that neither subgroup nor sensitivity analyses linked bevacizumab with a survival advantage.

The researchers conclude:

"In the future, for malignancies like NSCLC that disproportionately affect elderly patients or where the CMS covers a large proportion of treatment costs, negotiations with pharmaceutical sponsors of pivotal trials might mandate adequate representation of elderly patients and/or preplanned subgroup analyses relevant to the Medicare population.

Absent this information, clinicians will need to rely on efficacy data from subgroup analysis of randomized trials, observational data such as this report, and their clinical judgment to make treatment recommendations.

Given that neither subgroup analyses from efficacy studies nor observational data analyses identify a benefit for adding bevacizumab to standard carboplatin-paclitaxel therapy, bevacizumab should not be considered standard of care in this context. Clinicians should exercise caution in making treatment recommendations and should use bevacizumab judiciously for their older patients."

Written By Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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"Carboplatin and Paclitaxel With vs Without Bevacizumab in Older Patients With Advanced Non'Small Cell Lung Cancer"
Junya Zhu, MS, MA; Dhruv B. Sharma, PhD; Stacy W. Gray, MD, AM; Aileen B. Chen, MD, MPP; Jane C. Weeks, MD, MS; and Deborah Schrag, MD, MPH
JAMA, April 2012, doi: 10.1001/jama.2012.454 Please use one of the following formats to cite this article in your essay, paper or report:

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China Halts Several Drugs

Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharmacy / Pharmacist
Article Date: 17 Apr 2012 - 13:00 PDT

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With infant formula scandals, mine collapses and pollution and contamination problems, China is not well regarded for its industrial safety record, and today the story continues with 13 different drugs produced in China being pulled from the market by the Government regulator.

In a statement issued on Sunday, The State Food and Drug Administration confirmed that it had requested local authorities to inspect capsule manufacturers in their provinces. The problem appears to stem from very high chromium levels in the capsules rather than their contents, thus it affects products varying from herbal medicines through to antibiotics in a variety of locations.

CCTV said in a report that the gelatin from companies in northern Hebei Province and eastern Jiangxi Province and used in the capsules manufacture was made from scraps of leather material. It's clear that Chinese authorities face many challenges as they attempt to prevent the use of illegal additives often manufactured in fly-by-night factories.

There are no reports of the medicines being distributed beyond China, but there have been incidents in the past, including the dramatic baby formula that contained no nutritious value whatsoever, and the deaths of 80 people in the United States due to Heparin (a blood thinning product) and marketed by Baxter International that was crudely made.

Countries around the world are growing increasingly wary of product standards from China, especially in the healthcare industry. The FDA has been criticized for not inspecting imported products more thoroughly, and it has taken action by banning ingredients from certain Chinese companies. The heparin incident from 2008 was caused by oversulfated chondronitin sulphate; the FDA has asked manufacturers only to use heparin from pig intestines and avoid cost saving dodges.

The FDA has released a statement in regard to product safety. Christopher Hickey, Ph.D., who leads FDA's 13-person staff in China, says the agency has trained more than 1,600 manufacturers and regulators on United States safety standards over the past two years. He continues that :

"The FDA's China office represents a new era in cooperation between the United States and China on the safety of food and medical products."

Michael Kravchuk, who served as deputy director in Beijing until he retired in September, says FDA has built solid relationships with Chinese regulators and exporters since officially opening an office in the capital city of Beijing in November 2008. After a two-year stint in China, Kravchuk says he realized that FDA and their Chinese counterparts are working toward a common goal :

"What I realize is we are all trying to ensure quality products are on the market, regardless of where they are sold. They want to learn how we approach product safety and use as many of our techniques as possible."

The FDA is seeking additional funding for 2013 to be able to better inspect and analyze imported products, especially those from China. They are also planning to inspect manufacturing sites in China and conduct evaluations of sites that are undertaking clinical trials of products planned for import to the US.

The agency certainly has its work cut out for it, with some 24 million shipments of FDA-regulated products arriving into the USA during 2011. Murray Lumpkin, M.D., FDA's senior advisor and representative on global issues, says the foreign outposts give FDA a way to address safety issues before products leave the country of origin :

"By helping other nations develop stronger regulatory systems and helping industry to understand our expectations and realize they will benefit from them, we're also helping ourselves and keeping U.S. consumers safe."

Written by Rupert Shepherd
Copyright: Medical News Today
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Anti-HIV Pill Could Be Cost Effective For High Risk Men

Editor's Choice
Main Category: HIV / AIDS
Article Date: 17 Apr 2012 - 14:00 PDT

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Stanford University researchers have concluded that a once a day pill designed to prevent the spread of HIV could prove cost effective for high risk members of the population. The drug, known as tenofovir-emtricitabine, reduces the risk of HIV infection by nearly fifty percent in a 2010 clinical trial, and the test subjects who reported taking the pill religiously, had upwards of seventy percent reduction in HIVB infection.

The pill, which is sold under the brand name Truvada, is also used for treating those already infected with HIV, but a landmark study in 2010 proved it effective for preventing the spread of the disease. The drug's maker, Foster City, Calif.-based Gilead Sciences Inc., has filed a supplemental new drug application to allow its use for prevention purposes.

The scientists at Stanford were interested to see whether giving the pill to large tracts of the population would be cost effective. The prevention technique, known as pre-exposure prophylaxis, or PrEP, simply aims to prevent the spread rather than cure the virus. By focusing on men who have sex with other men (MSM), who account for more than half of the estimated 56,000 new HIV infections each year, they were able to create an economic model for PrEP.

Jessie Juusola, a PhD candidate in management science and engineering in the School of Engineering and first author of the study said :

"Promoting PrEP to all men who have sex with men could be prohibitively expensive ... Adopting it for men who have sex with men at high risk of acquiring HIV, however, is an investment with good value that does not break the bank."

The study, published in The Annals of Internal Medicine, shows that giving the pill to the general MSM population would cost nearly $500 Billion, whereas targeting only high risk sectors drops the price by more than 80%. In the past, it was not thought that giving the pill would be possible due to high costs, but the Stanford study takes a new approach.

The team went on to estimate the costs of the pill, which comes in at $26 a day and spread over time would produce a $50,000 per quality-adjusted life year. Jusola continues that :

"... even though it provides good value, it is still very expensive ... In the current health-care climate, PrEP's costs may become prohibitive, especially given the other competing priorities for HIV resources, such as providing treatment for infected individuals."

The study doesn't make clear whether the costs per dose would be reduced by manufacturing and distributing it in large quantities, although there is a study underway to see whether the drug can be effective if taken less often, which obviously reduces some costs. Others have commented and questioned the intelligence of giving a drug which does have some possible toxicity and side effects in such large quantities.

Written by Rupert Shepherd
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