Ceva’s Response to Pharmacosmos Study on Impurities in FDA-Approved Injectable Iron Solutions

18
810

It is a medical fact that iron-deficiency anemia among baby pigs poses a risk to both animal welfare and productivity, as baby pigs are highly susceptible to iron deficiency. An injection of iron shortly after birth remains the scientifically proven, most effective way to prevent anemia in pigs.

Today, there are a number of FDA-approved injectable iron products currently on the market that have been used by thousands of pork producers for many years to effectively prevent iron-deficiency anemia. It has been clearly demonstrated over many years that this class of products is unequivocally safe for use as indicated in baby pigs. More importantly, there has been no documented negative impact on food safety.

Recently, a scientific journal article (May/June issue JSHAP), based on a study funded by Pharmacosmos, a maker of injectable iron, has been published that implies that there is risk to both pig health and food safety from the use of FDA-approved injectable iron products.

These implications are categorically untrue and are not substantiated by any scientific research.

More importantly, these implications, in an attempt to differentiate and promote one iron product over another, jeopardize the reputation of the entire food animal industry and place consumer confidence in pork products at risk.

Stringent policies and procedures developed by veterinarians, governmental agencies, scientists and conscientious food chain partners are in place to ensure safe, healthy food for consumers. This is the industry’s most important responsibility.

The FDA has approved Ceva’s GleptoForte® and other injectable iron products to be safe and effective. To imply otherwise does a tremendous disservice to the industry and consumers worldwide.

18 COMMENTS

  1. Ceva’s response is nothing more than admission of guilt. This is a company that fraudulently used a DUN number to register a non pharmaceutical ingredient (Phytosphingosine, as cosmetic ingredient as per the manufacturer, Evonik) to list an unapproved drug!

  2. The article evaluated Elemental impurities in injectable iron products for swine and found that under the conditions of this study, Ceva’s GleptoForte® contain levels of arsenic, chromium or lead exceeding the human PDE for each respective impurity.
    Uniferon was the only product tested with undetectable levels of arsenic and lead while having a level of chromium lower than the human PDE. This study was conducted by Scott L. Radke, DVM; Chris W. Olsen, DVM, MS; Steve M. Ensley, DVM, MS, PhD, these folks are either DVM or PhD (and in some cases both).  On the contrary Ceva’s  regulatory is run by community college graduate with a BS!! (she will not even get a technician’s job at Iowa state lab!). That speaks about the quality of the study and Ceva. These results have serious  public health consequences and swine owners and vets should stop using Ceva’s GleptoForte® (a company that fraudulently uses a DUN to list an un-approved drug will do anything to get a few bucks) 

  3. Any potential risk associated with parenteral exposure of arsenic, chromium or lead to piglets can be avoided by using an injectable iron product with levels of these impurities below known human PDE limits.
    Manufacturers of injectable iron products for swine should take all steps necessary to ensure their product is void of any potentially harmful impurities, including heavy metals. Why is Ceva attacking the truth? May be a community college graduate running regulatory may know more about animal and public health than DVM/PhDs!!  Why cant Ceva get rid of heavy metals that can cause target organ toxicities in humans? Is few bugs more important to the company than the health of the public? 

  4. Heavy metal impurities found in Ceva’s GleptoForte® 

    New data show concentrations of arsenic, chromium and/or lead exceeding the permitted daily exposure limit for humans in Ceva’s GleptoForte® injectable iron product for piglets.
    The data show that arsenic, chromium and lead can inadvertently be administered with iron injections to pigs depending on the product used. “These substances should be avoided in the pork production chain and it is up to the pig producers to make sure that arsenic, chromium and lead are not injected into piglets,” says leading expert in swine health Professor Jens Peter Nielsen, DVM, Ph.D., Dipl. ECPHM, Nutrition and Health, University of Copenhagen, Denmark.

    The analysis was carried out by an FDA-certified independent contractor testing laboratory and the Iowa State University Veterinary Diagnostic Lab, one of the leading universities for veterinary medicine. The concentration of the heavy metals arsenic, chromium and/or lead exceeded the FDA and EMA permitted daily exposure limit for humans.
    Experts agree that heavy metals like arsenic and lead are recognized risk factors for human cardiovascular disease and have been associated with peripheral arterial disease, electrocardiographic abnormalities and left-ventricular hypertrophy.

    Risk even at low levels of exposure: The results add to a growing pool of data on the role of environmental threats to human health. A recent study by Bruce P. Lanphear and colleagues, published in The Lancet Public Health 5, demonstrated that low-level lead exposure is an important and largely overlooked risk factor for death, particularly for cardiovascular disease deaths. In fact, the study showed that even blood lead concentrations lower than 5 μg/dL (<0,24 μmol/L) are associated with all-cause mortality, cardiovascular disease mortality, and ischemic heart disease mortality.

    In an expert comment in The Lancet 6, international public health expert Dr. Philip J. Landrigan noted an especially striking and unexpected finding whereby the association between lead and disease is proportionately greater at lower levels of exposure-a so-called supra linear dose-response relation. "Considering recent evidence which demonstrates how low levels of exposure, especially to lead and arsenic, can have negative effects on human health, toxic heavy metals should not be knowingly injected into food production animals," says Professor Steve Ensley, DVM, MS, Ph.D., who is a veterinary toxicologist from the Iowa State University Veterinary Diagnostic Laboratory, Vet Diagnostic & Production Animal Medicine, and the senior author of the publication in JSHAP.

  5. In an expert comment in The Lancet 6, international public health expert Dr. Philip J. Landrigan noted an especially striking and unexpected finding whereby the association between lead and disease is proportionately greater at lower levels of exposure-a so-called supra linear dose-response relation. “Considering recent evidence which demonstrates how low levels of exposure, especially to lead and arsenic, can have negative effects on human health, toxic heavy metals should not be knowingly injected into food production animals,” says Professor Steve Ensley, DVM, MS, Ph.D., who is a veterinary toxicologist from the Iowa State University Veterinary Diagnostic Laboratory, Vet Diagnostic & Production Animal Medicine, and the senior author of the publication in JSHAP.

    It may be difficult for a community college educated person to understand the health ramifications of these findings! 

  6. Ceva’s response to a grave animal and human health issue shows the culture of the company and the quality of the people in the organization. When the leader of the company only has a bachelor’s degree (and whose marriage ended in a divorce!! ) and HR in charge is there because the guy who runs the company feels differently, there will be no professionalism! Most of the CEOs of quality companies hold MBA’s from known business schools, regulatory will be led by DVM/PhDs with in depth knowledge of the regulations and public health significance of drugs used in food animals. Ceva is not that type of company and as someone pointed out when the scientific and regulatory is run by someone not “corrupted by professional or graduate school education” the company will take short cuts and the public will be at risk. Worse is that when truth was exposed by qualified scientists with reputed credentials, community college educated quacks are challenging the facts.!!! Again, this is a company that lists cosmetic ingredients fraudulently as active ingredients to avoid FDA actions and  worse is that it is supported and orchestrated  from the top. Remember quality products come from quality people and arrogance is not a substitute for education, let alone managment and professional education. 

  7. The mere approval of a product by FDA/CVM does not mean that the product carries no risk, again a community college graduate mentality!. The Food & Drug Administration banned the use of diethylstilbestrol (DES) as a growth promoter in livestock because like the heavy metals id posed human risk!! . 

    A synthetic hormone used since the 1950’s to promote faster weight gain in cattle and sheep, DES was first banned by FDA as an animal feed additive in 1972 following reports from the Department of Agriculture that residues of the compound were showing up in meat products. In 1973 FDA also banned DES for use as a tissue implant in food animals. Both decisions were overturned in early 1974 when the U.S. District Court of Appeals for the District of Columbia found that FDA failed to hold all legally required administrative proceedings before acting.
     

  8. This animal health company is making me laugh with their stupid response !. A search of the company personnel showed that the CEO has a bachelor’s degree and person responsible for heading the regulatory affairs is community college educated! I guess that is the problem here, because when your knowledge level is so small, you cannot fully comprehend complex scientific issues! When highly educated professionals with decent initials rationally and with documentation states an issue these community college graduates should listen and withdraw the product, that is the honorable thing to do.  I would encourage the swine producers and those who have likely consumed the pork contaminated by treatment with Ceva’s product bring a class action suit. 

    I can’t believe that this company will use fraudulent DUN to list a product with cosmetic ingredient, this again shows the value of the company. This company also markets a product called Vectra, an antiflea medication, and this product so dangerous to pets and pet owners.  Just Google and  you will find out the toxic nature of this product. 

  9. I am a qualified regulatory professional and Ceva’s arguments here makes no sense. May be it is the company culture or may be it is the lack of sound technical knowledge when interpreting data!. I am surprised that Ceva’s regulatory affairs is headed by a poorly educated person (BS degree, nowadays a technician’s job in a scientific field needs more than that) but more alarming is that Ceva is refusing to take action on heavy metal contamination in their product. Heavy metals pose severe health risks to humans and target animals. There should be a class action suit against Ceva for exposing the public to heavy metal toxicosis through a contaminated product. If you cant guarantee the safety of your product, you should not be in this business!!. Please do not use vectra-it has so much side effects in dogs and cats and also can be dangerous to humans. 

  10. Ceva management, people are questing your credibility,ethics and standards under which you operate. Did your regulatory indulge in fraudulent use of DUN to list product containing a cosmetic ingredient? Is that violation of federal statutes? is your silence an admission of guilt ?

  11. Ceva animal health is a company with not much scrupulous business ethics or morals. A search of Ceva products showed that the company is listing climbazole and phytosphingosine as active ingredients probably using incorrect DUNS because Evonik has categorically stated that phytosphingosine is a cosmetic ingredient and not a drug, either Evonik is lying (I doubt that) or Ceva is not being honest. Eva’s anti flea product Vectra is the most unsafest flea product in the market and Ceva has no hesitation to market it even though the product is known to cause serious heath issues in dogs and cats and pet owners. Now Ceva is standing by heavy metal contamination in a product that will enter the human food chain!!. I hope swine producers would bring a class action suit against this  Unscrupulous company. No wonder people with not much education run this company!! 

  12. “The FDA has approved Ceva’s GleptoForte® and other injectable iron products to be safe and effective. To imply otherwise does a tremendous disservice to the industry and consumers worldwide” FDA approval does not mean that the product is free from heavy metal contamination! Flint city officials approved the city water to be safe and rest is history! DES was once approved by FDA and does CEVA advocate the continued use of DES? Grow up CEVA and get some decent education from decent schools! There are degrees called DVM, PhD, MBA etc and by the way these are not awarded from community colleges!!

  13. CEVA animal health, Are lead, arsenic, mercury safe metals for human consumption? Well educated toxicologists with decent credentials says that these metals will cause health issues. CEVA says they are ok because “FDA approved” these poison laden product! Why should we believe you? Can you publish the credentials of the person running your department responsible for FDA approval? Is that person a DVM. PhD or both? Knowledge and credentials matter CEVA! Your Vectra product is very unsafe and causes issues in dogs and cats, stop marketing that product for animal safety!

  14. CEVA, will your CEO/Regulatory person in charge drink a concoction of lead, arsenicsnd mercury (at the levels present in your product) every day? 

    Is Phytosphigosine a drug? Does that come from an FDA registered facility? 

    Why is that Vectra causes many serious adverse reactions in dogs/cats and pet owners? We will release an independent study on this soon!. 

    Why are you so silent on this? Is your silence an admission of guilt? 

  15. CEVA: There are serious allegations and allegations of fraudulent ways of your company conduct business including but not limited to marketing of products contaminated with toxic heavy metals and listing cosmetic ingredigns as active pharmacuetical ingredients by using fraudulent DUNs. It is now speculated that these allegations of fraudulent activities were initialed and/or approved by Craig Wallace, CEO and Alicia Henk, Director of regulatory affairs? Are these true?  Is your silence an admission of Guilt or embarrassment? 

  16. If the CEVA management had grain of shame or self respect, they would not be running away from being exposed.  

  17. Ceva’s response to the journal article behest nothing but reinforces the contempt the company has shown for public safety. Again and again, the company has shown that it will cover up the truth for the few bucks these dangerous products will bring to the company. No company with decency and honesty will use a fake DUN to FDA list phytosphingosine containing products. Worst was this was done at the direction of Craig Wallace, the CEO and supported or at the behest of the Director of Regulatory Affairs, Alicia Henk and Ms. Koenig.  They still market Vectra, a very toxic and unsafe flea medication and now supporting a heavy metal dosed iron parental injection in a food producing animal-as someone pointed out, will these three individuals drink a cocktail of heavy metals at these concentrations every day for 10 years? Worst is that Ceva has not responded to any of these comments and the silence is clearly an admission of guilt. . 

  18. Study conducted by Scott L. Radke, DVM; Chris W. Olsen, DVM, MS; Steve M. Ensley, DVM, MS, PhD.

    Ceva Regulatory and Mangament; Alicia Henk, BS!! Director, Craig Wallace, BS!!! CEO!!!

    Let the readers decide who has decent initials and credentials and whom to believe. CEVA should be given nobel prize for inventing Phtosphongosine as an active pharmaceutical ingredient!!! with a fake DUN! 

LEAVE A REPLY

Please enter your comment!
Please enter your name here