IKEA Food Scare Highlights Food Safety Diagnostics

The recent discovery that some of retailer IKEA's trademark meatballs in its European stores contained equine DNA will focus attention on the need for better controls for the food supply for some highly dangerous threats, according to Kalorama Information. The healthcare market research publisher said the recent coverage of several contamination and impurity incidents in food will drive sales of food safety diagnostics technologies. Kalorama covered the market for food safety testing products in its recently published report, "Food Safety Diagnostics."

It's a rough story for a fantastic retailer but it highlights the damage that a food safety scare can do to a company.  This is an international retailer that used food only as a marketing item and can rely on positive PR of the quality and price of furniture products to survive. For a food company, this might have marked the end of business. 

For its part, IKEA has stopped sales of Swedish meatballs from its 18 UK sites and stopped sales from the same run in 12 other European countries after Czech inspectors found equine DNA in a consignment last week. IKEA is a furniture retailer but sells the meatballs in its novelty cafeterias in its huge box stores. The checks were carried out in response to a Europe-wide scandal that erupted last month when tests carried out in Ireland revealed some beef products contained horsemeat. Kalorama noted that in the largest market, the United States, IKEA says its meatballs are sourced from an American supplier.  They also say the meatballs in the USA contain only beef and pork, which should limit some of the damage in the world's largest market. 

However, Kalorama sees that the problem is not only with authenticity of food but quality of food even when it is authentic.

The larger danger is not so much horsemeat but beef, chicken or even vegetables that may contain a toxin, and do physical damage to a person.  IVD companies who design medical tests now are the experts at developing testing products, and I would expect more of them getting involved. 

Testing for drug residue, for bacteria and for environmental toxins is essential to public health, according to Kalorama, and technologies such as microbiology and molecular testing exist that can assist food providers to calm public fears.  

Kalorama Information's "Food Safety Diagnostics" covers the market for IVD test products used for food testing purposes. The report details the market by threat, including Pathogens, Toxins, Agricultural Chemical/Veterinary Drug Residues, Allergens, and GMO/Authenticity. The report can be found at http://www.kaloramainformation.com/Food-Safety-Diagnostics-7326556/.

The Mystery of the Rancher's Affliction: Tracking Epigenetic Cancer

From Kalorama's Epigenetics Analyst, K. John Morrow, PhD: 

"Years ago I collaborated with a hematologist, Dr. Philip Periman, in Amarillo Texas, whose research interest was multiple myeloma. He saw a lot of patients with this disease; at that time (15 years ago) it was a death sentence, although it could be held at bay for some years. He was struck by its high incidence in ranchers and farmers in the Texas panhandle. Exposure to pesticides and other farm chemicals was long suggested as a risk factor. Recent work provides an explanation: these chemicals are epimutagens, myeloma appears to be an “epigenetic cancer” and it can be successfully treated with drugs that block methylation of cancer-causing genes.

Pomalidomide and lenalidomide are FDA-approved derivatives of thalidomide. They are slight modifications of the original thalidomide molecule, which achieved beneficial results, but also caused unpleasant side effects. When given to patients with multiple myeloma, they block the methylation of the gene p21^WAF . This proceeds through a modification of the chromatin structure of this region, so when unmethylated, the p21^WAF gene product is synthesized. This protein is a potentcyclin-dependent kinase inhibitor which functions as a regulator of the cell cycle. The end result is a self-destructive cascade resulting in the death of the tumor cells. These drugs have been so successful that they have kept myeloma patients alive for years, as reported recently by NPR (http://www.npr.org/blogs/health/2013/02/18/172098789/targeted-cancer-drugs-keep-myeloma-patients-up-and-running).

So the picture of cause and effect looks clear. Pesticides and other epimutagenic compounds methylate suicide genes, shutting them off, so cells lose control of division. This results in cancers such as myeloma which can be destroyed by reactivating the suicide pathways through drugs that cause demethylation.  In the years to come we will see this as a recurrent theme in the origins and treatment of many different cancers. "

Kalorama Information's Epigenetics Market Research Report, authored by K. John Morrow, PhD, contains a full analysis of treatments and tests for epigenetics, including relevant companies and market sizes and forecasts.  The report  is available for purchase at http://www.kaloramainformation.com/Epigenomics-Future-Applications-7087795/

When Delivering Vaccines, Needle-Free Solutions Sought

Needle-free jet injection devices can and should play a major role in solving the problems of needle-stick injuries and needle phobia in the United States. However, the needle-free jet injector industry is struggling to overcome significant obstacles in this country and abroad before these devices become widely accepted and used for administering drugs and especially vaccines. 


Kalorama feels that the line between drug delivery and drug substance will continue to become more elusive in the near future as shown in the analysis, as researchers work to improve drug properties through drug design and molecular modeling.  Consequently, in the next decade, drug delivery technologies will be a focal point of competition within the pharmaceutical industry. 

The success of specific drugs will be tied to innovative delivery techniques, which will enable the targeting that will exploit the clinical properties of a new generation of drugs.
The implantable/injectable drug delivery market is growing rapidly. The development of better delivery systems in conjunction with the discovery of novel pharmacological compounds will lead to significant improvements in drug delivery. The market for implantable/injectable drug delivery is a dynamic market that is expected to increase during the forecast period. There will likely be significant increases in revenues of needle-free delivery of injectable medications especially in the vaccine arena. 


Most needle-free jet injectors use metal springs, compressed air, or CO2 gas to power the injection. The device's nozzle is held against the patient's skin and once activated, the device injects a fine stream of the vaccine or drug at a high pressure into the skin. The most common orifice size is 0.127 mm, whereas that of a 25-gauge needle is 1 mm.

Kalorama information projects growth in these systems in its new report: 

The World Market for Injectable, Implantable and Needle-Free Drug Delivery Systems

New Report Shows Rising IVD Procedures

Testing is on an upward trend, according to Kalorama Information's IVD Procedure Volume and Pricing Analysis   Clinical laboratory medicine plays an integral role in healthcare and disease management, as it estimated that approximately 80% of physician’s diagnoses are a result of laboratory tests.

Lab procedures will go from 19 billion in 2012 to 23.5 billion in 2017, according to our procedure volume analysis, as testing proves its importance in diagnostics and treatment regimen decisions to providers, payors and patients.

 In addition to disease diagnosis, clinical lab testing is also performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

Diagnostic laboratory technology has changed dramatically in the past few years, due to the publication of the human genome project and advances in functional genomics, bioinformatics, automation, miniaturization and microelectronics as well as rapid development and proliferation of novel telecommunications technologies.  Molecular assays are among the fastest growing procedures, according to the report.  

Surprise Over Oxytrol Approval

In a press release last week, Kalorama Information said that there would be more Rx to OTC switches, and to count on it.... but we had no idea how quickly that would happen.  Last Friday, the FDA announced that Oxytrol was approved by the FDA for OTC status this year.   Merck's OXYTROL is a prescription medication that has been proven to treat the symptoms of overactive bladder.   The product is expected to be released end of year.  

The FDA advisory panel in November recommended not allowing the drug to switch yet, so Kalorama did not include the product in it's Rx to OTC Switches report.  

"Everyone is a bit surprised," analyst Melissa Elder tells the Kalorama Editors. "especially in light of no restrictions mentioned--such as pharmacist-dispensing option--and the concern over men gaining access to the product without the monitoring of a pharmacist. "

According to Elder, it raises some concerns over the possibility of men not being evaluated for prostate problems--and as we all know many men will avoid a Dr. visit if at all possible. 

Kalorama had forecasted 2014 approval in its report so our forecast is not affected in any large scale by the faster than expected approval, especially as Merck should not see revenues until fall 2013.    

Even Beds Subject to New Device Tax

From Kalorama Information's medical bed analyst and author of The World Market for Medical Beds Mary Ann Crandall, medical beds are subject to the new 2.3% medical device excise tax that went into effect in 2013.  " Anything that has a 510k,  which would include medical beds is subject to the tax. " she told the Kalorama Editors this month.  

Some companies have already seen the effects.  Hill-Rom Holdings said that it would lay off about 3% of its workforce, or roughly 200 workers, as it maneuvers to confront the medical device tax set to go into effect next year.    

Of course that beds would be considered a medical device is not surprising to Kalorama, our report on medical beds gets into the features that these beds provide.  Electric beds, birthing beds, respiratory treatment beds and bariatric beds for overweight or obese patients are among the specialty beds that companies provide for hospitals.  

Behind The Counter (BTC) Drugs: Are We There Yet?

Drug products typically fit into two segments: over-the-counter and prescription. However there are a small number of drugs that fit in a segment called “behind the counter.” These drugs require the consumer to get the attention of the pharmacy staff in order to obtain the medicine.  Typically a drug would not need the high level of doctor supervision but still raises concern for direct consumer access.

 The FDA has been discussing the possibility of formalizing a behind-the-counter (BTC) product segment since the 1970’s. Even without specifically establishing a third class of drugs, there is potentially more pharmacists can do to help patients. Currently there are select products such as Mucinex, a cough medicine, and Plan B, an emergency contraceptive, available through BTC status. These products can be purchased without a prescription and customers have better access to them than prescription products.

In mid 2002, Adams Laboratories made a bold move to put its new cough tablet Mucinex in this unique third drug category. For the first time, consumers can buy a cough medicine tablet that contains guaifenesin, a powerful phlegm-releasing ingredient. The drug is available OTC but can be obtained only by getting the attention of someone at the pharmacy counter.  The company considered placing the product next to the standard OTC cough preparations such as Vicks and Robitussin, but that would have required the company to spend millions of dollars in print and TV ads. The company opted for the third drug category, dispatching its sales force to lobby doctors about Mucinex and its unusual location in stores.

Drugs containing pseudoephedrine (a decongestant found in various OTC and prescription products), ephedrine and phenylpropanolamine have been moved behind the counter due to use in illegal methamphetamine production. This process was started in 2005 and continued in 2006 with the Patriot Act signed by President Bush in March of 2006. Some states in the U.S. have required that products containing the drug be limited to prescriptions only.

Another argument for the addition of BTC products is the availability of more products at lower prices.  The growing consumer trend in using OTC products would also be seen in the BTC category. The improved access over prescription medicines could provide consumers with a source for treatments that only requires a kiosk or pharmacist involvement. Pharmacists could potentially provide support either through counseling before the purchase or by limiting the purchase quantities. Pharmacists have the knowledge to advise patients about drug interactions as well.

Drug companies have also shown an interest in a BTC option for marketing a product. This may be a good way to provide access in a way that fits products better, and gives companies more options. In effect a product may not be safe enough for OTC status but not unsafe enough for physician monitoring.

The FDA has continued to look at several ways to increase access to medicines but also remove the burden on physicians. Physicians offices must take time to see a patient, send in prescriptions orders, or schedule a second visit even for some routine cases which takes time away from more critically ill patients. Physicians are considered the most qualified personnel to make health decisions but there is continued pressure to change the system in a safe and effective manner. 

Insurance companies have reported mixed feelings about reimbursement for BTC medicines. Some companies say that if the medication is medically necessary and/or covered under the patient’s formulary, they would provide reimbursement. However, other health insurers may be less likely to provide reimbursement if this segment of medicine materializes. Some of the reimbursement options would likely follow a certain decision by the FDA concerning the specific type of access granted. 

Product classes which could benefit from a third class of drug include oral contraceptives, influenza antivirals, sexual dysfunction treatments, bladder treatments, osteoporosis prevention, and hormone replacement drugs.

An industry evaluation of these potential costs savings indicates that some of the savings would be shifted to the pharmacists to pay for added consultation and to the manufacturers. If a product requires diagnostics the savings may be limited. Expanding OTC access is likely to be more beneficial on a product-by-product basis. If a consumer is looking for a simple product that requires only a kiosk, the costs could be less than if they require a blood test administered at a pharmacy. 

Kalorama's Reprot, Rx to OTC Switches, discusses this topic.