On May 10, the FDA approved an application by Prognostix, Inc. of Cleveland, Ohio, to market (to doctors) a test kit known as the CardioMPO which, in clinical trials, proved quite accurate in predicting which patients were at risk to suffer a “major adverse cardiac event.”

The application submitted by Prognostix on January 6 of this year defines the test as an “enzyme immunoassay” intended for the “quantitative determination of myeloperoxidase (MPO) in human plasma, to be used in conjunction with clinical history, ECG and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.”
Patients complaining of chest pain or discomfort have always presented a difficult diagnostic challenge whether in an emergency room, doctor’s office, or non-medical setting. Doctors are constantly being called upon to determine if a patient is suffering some relatively minor transitory condition or a more serious cardiac event requiring immediate aggressive intervention.

The most common symptom of a heart attack is chest pain or chest discomfort, but in many cases even the patient is uncertain if they are having a heart attack. However, many cases go undiagnosed even in the emergency department, and this diagnostic error makes acute myocardial infarction (AMI) the single leading malpractice litigation-related condition.

In addition, because the most common profile for AMI is in older men (usually over 45), AMI is often misdiagnosed in women or younger adults. In any patient, however, AMI can have a variety of presentations, and diagnostic tests such as an EKG may still be normal. Misdiagnoses of AMI include gastrointestinal disorders (26% of misdiagnoses), musculoskeletal pain (21%), or respiratory ailments such as pneumonia or bronchitis (6%).
Moreover, there are also less serious disorders that are mistakenly believed to be heart attack. A common example are people having a panic (anxiety) attack and will rush to an emergency room believing they are dying from a heart attack.

The CardioMPO test provides an additional means of quickly separating minor medical emergencies from life threatening ones. When used in combination with other diagnostic tools and taken into consideration with other risk factors, the test may prove to be a life saver.

MPO is a protein produced in white blood cells. It is also found in clogged areas of heart arteries which are vulnerable to rupture. Elevated levels of MPO in people with chest pain or discomfort signals the existence of short-term risk of a major adverse cardiac event such as a heart attack or the need for surgical intervention to restore normal blood flow to the heart. High MPO levels are also a possible indicator of an increased risk of heart-related death within 6 months.

The CPSC has announced the following provisional settlement with Rose Art Industries, a toy and art materials manufacturer, for failing to report important product safety information to the Commission.

The settlement will impose a $300,000 penalty against Rose Art, of Livingston, N.J., for failing to inform the government in a timely manner about a defect in soap making kits that led to injuries to young children.

Between August 1997 and December 2001, Rose Art made and sold about 125,000 Glamour Gear Soap Making Kits nationwide. The kits, which are intended for children eight years of age and older, include bars of soap, molds and a plastic cup to melt soap chunks.

A defect in the plastic cup, which is used to heat the soap in a microwave, can cause it to deform or develop a hole in the bottom and pose a serious burn hazard to children.

Between January 1998 and January 2002, Rose Art received 10 reports of children who were burned by hot soap while removing the plastic cup from the microwave. The majority of the children suffered second and third degree burns.

The firm did not inform CPSC about the defect, injuries and the resulting civil litigation against the company until February 2002.

In March 2002, CPSC and Rose Art announced a recall of the soap kits. Consumers can log on to www.cpsc.gov/cpscpub/prerel/prhtml02/02121.html for information about receiving a refund.
According to federal law, manufacturers, distributors, and retailers are required to report to CPSC immediately (within 24 hours) after obtaining information which reasonably supports the conclusion that a product contains a defect which could create a substantial risk of injury to the public, presents an unreasonable risk of serious injury or death, or violates a federal safety standard.

In agreeing to settle the matter, Rose Art Industries denies that the soap kits were defective and that it violated the reporting requirements of the Consumer Product Safety Act.

Iressa (gefitinib) was approved by the FDA on May 5, 2003 “as a single agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Iressa was reviewed and approved under the FDA’s accelerated approval program, which is intended to allow patients suffering from serious or life threatening diseases earlier access to promising new drugs.”

Unfortunately, as has been the case with several “fast track” approvals in recent years, the lack of large-scale longitudinal tests prior to marketing has once more come back to haunt a drug manufacturer and the FDA itself.
On December 17, 2004, the FDA released a statement “regarding the failure of a clinical trial of Iressa (gefitinib) to show overall survival advantage in treating patients with lung cancer.”

This confirmed a notification from AstraZeneca on December 16, that “a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.”

On June 17, the FDA announced a new label for Iressa that “limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib treatment.” The FDA made it clear that Iressa should not be given to new patients because “in a large study Iressa did not make people life longer.”

Now, the Wall Street Journal has reported that complaints have been brought before two prosecutors by the families of cancer patients who died after taking Iressa against AstraZeneca. The company states that, while it has not received word of the criminal complaints, it has received notice of four civil lawsuits related to Iressa.
The drug, that was once believed to be the next multibillion-dollar blockbuster, was first reduced to little more than an expensive placebo when long-term testing showed the drug did not help lung cancer patients life longer. As of September 15, it will only be available in the U.S. to patients enrolled in continuing studies.
In Japan, some 22,000 patients have taken the drug since 2002. Significantly, doctors have reported that 600 of those patients died from interstitial pneumonia, a lung disease.
 
The criminal complaints allege AstraZeneca exaggerated claims as to the drugs effectiveness and ran advertising before the drug was approved. Japanese health officials had endorsed the drug in March by recommending that doctors continue prescribing it while AstraZeneca kept studying the drug to better understand how it actually works; something even the FDA never admitted understanding either.

A study of 237 children with type 2 diabetes done at The Children’s Hospital of Philadelphia and published in the June issue of Pediatric Diabetes, strongly suggests a link between that disease and previously diagnosed neuropsychiatric disease (NPD).

The study showed that 19% (46 of 237) of the children with newly diagnosed type 2 diabetes had previously been diagnosed with NPD. Those disorders included depression, attention-deficit hyperactivity disorder (ADHD), developmental delay, schizophrenia, and bipolar disorder.

The researchers also believe the link to work the other way around so that children with newly diagnosed type 2 diabetes may be at greater risk to develop NPD.

Thus, the findings suggest the need for additional screening practices for children with either condition. Dr. Lorraine E. Katz, a pediatric endocrinologist who led the study, stated: “Obese children with neuropsychiatric conditions should be screened for diabetes, and children with insulin resistance or type 2 diabetes should be screened for psychiatric conditions.”

The results of this study have added significance given the dramatic rise in obesity and type 2 diabetes among children. African American adolescents are particularly vulnerable to both conditions. Children with type 2 diabetes require major lifestyle changes. The study indicates additional challenges may be present if NPD is also present.

Researchers at University of Queensland (Australia) have found that antiretroviral HIV drugs known as protease inhibitors stopped the parasite that causes malaria from growing. Moreover, the drugs also worked on strains of the parasite that had developed resistance to common malaria drugs.

Malaria kills over 1,000,000 people worldwide each year with the heaviest toll among pregnant women and children under five. Despite more effective drugs and better mosquito nets, the problem is not getting any better due to bureaucratic delays and health system breakdowns in sub-Saharan Africa where 90% of the cases occur. Mosquitoes also develop resistance to every insecticide including DDT.

These latest tests, however, may be quite significant since the area of Africa most affected by malaria is also the area with the highest HIV rate. Studies have shown that people with HIV are twice as likely to catch malaria as those without the virus.

In addition, five of seven protease inhibitors were able to kill malaria parasites grown in the lab as well as in malaria-infected mice. The best results were obtained using combinations of ritonavir and saquinavir or lopinavir.  
Finally, the protease inhibitors were effective even against strains of the malarial parasite that had already developed resistance to common malaria drugs.

While the drugs are expensive and not without some serious side-effects, they may prove especially helpful to patients suffering from both HIV and malaria. They may also lead to the development of new treatments for malaria itself. Tests must also be done to see if other classes of anti-HIV drugs produce the same or similar results.

Canadian Food Inspection Agency (CFIA) scientists have found malachite green, a known carcinogen, in organically raised Chinook salmon in a second fish farm (Creative Salmon) on Vancouver Island.

The chemical, which was once used to kill fungus in fish eggs, was banned in Canada in 1992. Since that time, Health Canada has had a zero tolerance level with respect to the substance.

Creative Salmon has expressed shock at the findings and is unable to explain how malachite green appeared in its fish. The company has notified all of its customers as well as the local community of the situation and has suspended harvesting until further testing can be done to verify the results.

The company states it has never used the chemical and is hoping that there was a laboratory error. Additional samples have been sent to CFIA and an independent laboratory for analysis.

Creative Salmon ships most of its fish to the United States. It also ships to Japan and other areas in Canada including the local village of Tofino.

A local environmental group, Friends of Clayoquot Sound, sees this as one more example of the “cocktail of chemicals and contaminants” in British Columbian farmed salmon. It maintains that consumer protection must come first when carcinogens are involved and so all of Creative Salmon’s fish stocks should be destroyed.

The group is extremely disturbed by the fact that British Columbian farmed salmon is once again contaminated with a cancer-causing substance making it unfit for consumption.

Japan permits malachite green levels of 5 parts per billion. The United States does not test for the substance. The fish in question tested at 0.33 parts per billion.

The second farm with a positive test result earlier in June was one operated by the Stolt Sea Farm group.

Although several millions of doses of numerous generic prescriptions drugs were unexpectedly pulled from the market in a massive drug recall over one month ago, neither the FDA nor the manufacturer have come forward with any information to explain the matter.

On May 19, Able Laboratories stopped all shipments of its products. Four days later (May 23), Able took the highly unusual step of recalling its entire product line and suspending all manufacturing; something experts cannot recall having ever happened previously.

Able also withdrew seven approved applications to market various medications. Its Chairman and CEO also resigned.

The only reason Able gave for its actions was deficiencies in its testing procedures may have resulted in “sub or super potent” drugs.

With no products to sell and no manufacturing being done, the value of Able’s stock immediately plummeted by 85%. On May 27, Able announced 200 job cuts.

Over the past 14 years, Able has had many problems with the FDA including: over 10 drug recalls; charges of selling medications which were either adulterated, mislabeled, or with incorrect potency; failure to report serious adverse reactions with respect to at least five drugs; improper extension of drug expiration dates without proof the drugs would still be effective; and selling drugs with the wrong package insert.

Able has received a number of FDA warnings with respect to these deficiencies and it is unclear what measures the agency will impose with respect to the company’s latest revelations concerning deviations from proper manufacturing practices.

A full list of the recalled products, with identifying tablet imprint codes or liquid formulation lot numbers, is available at: http://www.fda.gov/oc/po/firmrecalls/qualitycare06_05.html. Additional information concerning Able Laboratories can be obtained by calling 1-888-463-6322.

Although the FDA later attempted to justify the one week delay (May 27)  in advising the public of the massive drug recall as reasonable under the circumstances, many experts as well as consumer groups found the excuses to be unacceptable.

Dr. Sidney M. Wolfe of Public Citizen found the delay to be particularly troubling in light of the fact that the massive recall was based on what the FDA itself stated were “serious concerns that they (all of Able’s products) were not produced according to quality assurance standards.”

The FDA took the position that the additional time was needed to coordinate the voluntary recall with Able Labs and to prepare and publish a complete listing of  the recalled drugs on the agency’s website at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html.

In a related recall, the FDA and Quality Care Products LLC, a federally licensed drug repackaging company, notified consumers and healthcare professionals by letter of a recall of all repackaged Able drug products.

As truckloads of recalled drugs were brought back to the company, Able saw its stock drop 86% in value since mid-May. Additional layoffs were announced on June 9 cutting its workforce by over 50%. Its profits for the first quarter of 2005 had been up 25%.

Able has made no prediction as to when, or even if, production will resume. Its plan to open a new plant that would triple its production is now in question.   

All of this highly unusual activity is also raising serious questions as to the FDA’s enforcement procedures since Able passed 11 plant inspections in the past 3 years without mentioning any serious concern about the company’s manufacturing practices, and new-product approvals.

The FDA also approved Able’s applications to make 25 new generic drugs since 2001.

Now, without Able or the FDA clarifying the situation, both have advised patients to keep taking their medications until getting new ones from their doctors since abruptly stopping many drugs can be more harmful than taking the ones that were recalled.

Of course, that raises the question of what is really wrong (or thought to be wrong) with the entire product line that was pulled from the market? Obviously, the drugs are not suspected of being so compromised as to make taking them a life-threatening risk. Yet, only something relatively serious could prompt such an unprecedented recall of an entire product line and suspension of all manufacturing.

Clearly, the public, and especially Able’s patients, have the right to far more information than they have received so far.

For years the evidence has been mounting that children and adolescents with aggressive tendencies are susceptible to the increasingly violent images in video games and on television. Less than two weeks ago a new study even suggested that these extremely violent images may also be damaging the brains of youths who are non-aggressive, well-behaved, and ordinary. (See newsinferno.com for June 13)

That study, found “that individuals in the control group with high media violence exposure showed a brain activation pattern similar to the pattern of the aggressive group.” In the teenagers tested, the part of the brain involved in decision-making and self control was impaired by exposure to violent scenes.

The same effect was seen in both the group with a history of violent and disruptive behavior and the ordinary, well-behaved individuals. The researchers agreed that any association found to exist between exposure to media violence and brain functioning should be taken seriously.

Now, a team from the University of Aachen, Germany, has taken the research one step further by comparing the type of brain responses generated while playing violent video games to those triggered during acts of real aggression and while imagining violent behavior.  

The study, presented at the annual meeting of the Organization for Human Brain Mapping in Toronto, Canada, monitored the brain activity of 13 men while playing a violent video game that required them to kill terrorists among other things.

The magnetic resonance imaging (MRI) scans detailed how brain activity changed during violent and calm segments of the game. When violence was imminent, the information processing parts of the brain became more active.

When a fight scene was in progress, the parts of the brain which deal with emotion were shut down. This is precisely the pattern exhibited in MRI scans of people during acts of real aggression. Brain mapping scans also showed the same kind of activity as when people are imagining themselves being violent.

At least one proponent of the study suggested that regular exposure to violent video games may strengthen certain “circuits” in the brain so that a player faced with a real life violent situation might be more likely to react aggressively.

Critics of the theory see the link between the brain and violence as a complex one. The study does not explain why the same reactions are not triggered by violent films. In addition, Dr. Guy Cumberbatch of the Independent Communications Research Group (UK) stated: “The instinct to punch someone in the nose is pretty basic. I don’t think it is influenced in any way by playing these games.

At a time when drug prices are soaring to the point where the average person can no longer afford them, the Brazilian government is actually threatening to do something about it.

Brazilian Health Minister Humberto Costa has announced that the price of the anti-AIDS drug Kaletra is so high that it poses a risk to public health. Thus, under Brazilian law, the government has the authority to ignore the patent held by U.S. based Abbott Laboratories in order to allow generic copies of the drug to be made in the country’s state-run lab in Rio de Janeiro.

Abbott has been given 10 days to cut the price of the drug to an affordable level for the 600,000 Brazilians who suffer from HIV/AIDS.

While Abbott claims it is already selling its drugs in Brazil at a financial loss and argues that the move would not be in the long-term best interests of patients, it has obviously flinched at the threat and has stated it is “willing to work with the government to find a mutually agreeable solution.”

Brazil has won international praise for its policy of providing free anti-retroviral drugs to anyone who needs them. By pressuring a major pharmaceutical company to lower its price, even on one important drug, Brazil may have set a precedent that will send a strong message to an industry that places profit above compassion.

The CPSC, in cooperation with Target Corp. of Minneapolis, Minnesota, has announced a voluntary recall of 230,000 Birch and Bark Candles manufactured in China. Consumers should stop using the recalled product immediately.

The birch and bark surrounding the candles can ignite, posing a fire and burn hazard. While no injuries have been reported, there have been 18 reports of the birch and bark candles catching fire and five reports of property damage.
The candles were sold individually wrapped in a ribbon on a plate at Target stores nationwide from September 2004 through January 2005 for between $6 and $15.

The candles are cream in color and were sold in sizes 3-by-3 inches, 3-by-6 inches, 4-by-6 inches and 6-by-6 inches.
Consumers should return the candles to the nearest Target store to receive a gift card from Target in the amount of $15, plus applicable state taxes.

For additional information, contact Target at (800) 440-0680 between 8 a.m. and 7 p.m. ET Monday through Friday, or visit the firm’s Web site at www.target.com.