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Farah & Farah April 2016 Newsletter

Posted on April 5, 2016

Swine Drug Approval May Be Withdrawn Over Cancer Concerns
Pork may be the other white meat but it may be delivering more than protein to consumers.

Residue has been found in pork products of a drug linked to cancer called Mecadox. That is an antibiotic used to treat diseases in pigs, particularly those grown in commercial ‘factory farms” where diseases abound. It is also used by pork producers to fatten pigs before slaughter.

About 40 percent of pork producers use Mecadox, also known as the chemical, carbadox, according to a 2012 Department of Agriculture report.

The U.S. Food and Drug Administration (FDA) wants to rescind approval of the drug after determining consumers of pork products may also be consuming the carcinogenic residue. The drug residue was found in pork liver, liverwurst, hot dogs, sausage and other lunch meats, according to the FDA, and there is little scientific data to demonstrate it is safe. The agency says it is taking steps to rescind the approval through the Center for Veterinary Medicine (CVM) which oversees animal drugs.

“The manufacturer of carbadox has failed to provide sufficient scientific data to demonstrate

the safety of this drug given evidence that carbadox may result in carcinogenic residues,” said

Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine. “As a result,

FDA’s Center for Veterinary Medicine is taking legal action to remove this product from the

marketplace.”

In a not so comforting note, the FDA says it is NOT recommending people change their dietary

habits due to the potential cancer risk, assuming consumption of pork liver and liver products is

done on a limited basis.

The FDA recommends an alternative antibiotic to pork producers.

Factory farms have been using carbadox since the 1970s when it was approved to control

dysentery and the bacteria, enteritis, and to increase weight. But in 2014, the Codex

Alimentarium Commission determined there is no safe level of residues of the drug that

presents an acceptable risk to consumers.

The maker of carbadox has an opportunity to request a hearing. The manufacturer, Phibro

Animal Health, is reported to be incensed over the approval withdrawal citing 40 years of use in

the marketplace. Pharmalot reports the stock fell 2 percent at the news, released April 8.

The issue of emerging antibiotic-resistant superbugs is largely blamed on the use of antibiotics

by the meat producing industry, which uses more antibiotics in meat production than

Americans use to feel better.

The Centers for Disease Control and Prevention recommends antibiotics must be used

judiciously in both humans and animals because bacteria evolve in their presence to become

resistant.

With about 23,000 deaths annually blamed on antibiotic resistance, the phasing out of at least

one of these culprits is a good thing for consumers. #

Sources: https://www.statnews.com/pharmalot/2016/04/08/fda-antibiotic-pigs-cancer/ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494934.htm?source=g ovdelivery&utm_medium=email&utm_source=govdelivery  http://www.pahc.com/; https://www.statnews.com/pharmalot/2015/12/29/antibiotics-superbugs-bacteria/  http://www.cdc.gov/narms/animals.html

FDA Considers Reclassifying Surgical Pelvic Mesh Instruments

They are shaped like a stainless steel hook that might be seen as Captain Hook’s arm. We are referring to trocars, instruments used in urogynecological surgical procedures such as mesh placement.

The U.S. Food and Drug Administration (FDA) classifies these medical devices, as it does all devices that pass through its doors, according to the dangers it represents. Class I is reserved for elastic bandages and examination gloves and is considered the least likely to pose any risk to consumers and therefore is subject to the least regulatory control.

In fact, most class I devices are exempt from any premarket notification to the FDA because they are thought to be so benign.

Even though trocars pass through the nerve-rich pelvic area in a blind procedure and have been

found to be responsible for many internal injuries, they are still classified as having little to no risk, in other words, class I.

The FDA searched MDRs (Medical device reports) it had received from January 1, 2008 to December 2, 2015, to determine those associated with urogynecologic surgical mesh instrumentation. Inside that data, the agency found 463 reports of instrument-caused damage. They include, but are not limited to, piercing an organ such as bladder, urethra, to damaging blood vessels, nerves and other connective tissue.

In some cases the device malfunctioned, separated, broke, or cracked in the implantation tube. The instruments caused infection, adverse tissue reaction, nerve impingement and excessive bleeding. A capio needle, another mesh delivery device, had instances of breakage or failing to retract during use.

The packaged “mesh kit” comes complete with this instrumentation. Boston Scientific and Johnson & Johnson had the most adverse events, at 316 and 90, as complications are called within the FDA.

After many reports were made to the FDA’s injury database, known as MAUDE, it became clear that these trocars were not without the potential to cause tremendous harm especially in the hands of lesser trained surgeons.

As a side note, what was interesting was the FDA removed reports to its database that came from law firms since plaintiffs are usually involved in suing the defendant corporation. The reason given was “such reports typically contain few details and stem from patient litigation,” as if these are somehow less relevant reports than one that comes from one’s doctor.

In February, the FDA convened a special panel to consider whether these surgical instruments should be put into class II or moderate risk and adding special control for the use of urogynecologic surgical mesh instrumentation. The FDA believes risks associated with the instrumentation can be mitigated through special controls and that class II is the most appropriate regulation for these devices.

Many of those complaints come from the manufacturer and 161 of them said they were unable to confirm the complaint and 231 said the device was not returned, meaning their assessment of the device was inconclusive.

While it is known as one of the largest pelvic meshes used for pelvic organ prolapse (POP),

Prolift, previously sold by Johnson & Johnson, reportedly had a 39.1 percent injury rate for nerve injury, nerve damage leg pain, thigh pain, buttock pain and neurological symptoms.

The FDA generally follows the recommendations of its expert panels. Another interesting note- the FDA found there were far more patient complaints lodged against instrumentation used for SUI (stress urinary incontinence) mesh implants than for POP mesh implants.

At the present time the FDA is reconsidering POP mesh as Class III. SUI mesh will remain in class II. #

Sources:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalD evices/; http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicalde vices/medicaldevicesadvisorycommittee/gastroenterology- urologydevicespanel/ucm490205.pdf; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalD evices/MedicalDevicesAdvisoryCommittee/Gastroenterology- UrologyDevicesPanel/UCM487202.pdf

Few IVC Filters are Successfully Harvested

The problem Wendy is experiencing with an implanted medical device is not atypical.

Wendy had an IVC filter implanted three years ago. IVC stands for Inferior Vena Cava because that is the name of the main artery where it is placed. This is an important part of the body. The IVC brings blood up from the lower half of the body to the lungs and heart where it is used to keep us alive. Unfortunately, sometimes that blood carries within it clotting material – clumps of blood, air bubbles, part of a tumor or fatty material. These clumps generally originate from the lower half of the body, such as the legs, where it’s known as deep vein thrombosis.

If this clot blocks a portion of the lung, the tissue can be robbed of blood and die. If it is blocking oxygen and the patient is experiencing coughing, chest pain and shortness of breath, that could be a sign of a pulmonary embolism which is potentially life threatening.

These conditions may alert medical professionals to start a patient on blood thinners. In some

cases, such as when a patient cannot take a blood thinner, an IVC filter may be implanted in the inferior vena cava. Most of these filters are considered retrievable and supposed to be removed after the risk of the pulmonary embolism has passed.

What we are finding is that many of these filters remain in the bodies of patients where they do more harm than good with the passage of time. As with Wendy, when doctors finally went in to remove the filter, it had one leg broken and one leg piercing her jugular vein.

The Journal of the American Medical Association: Internal Medicine finds fewer than ten percent of retrievable filters are ever removed. A 2013 study at Boston Medical Center of 978 patients who had received a retrievable IVC filter, found only 8.5 percent were successfully removed. Attempts to remove were unsuccessful in 18.3 percent of the patients.

In 2010, the FDA issued a Safety Communication warning that surgeons should remove the IVC filter as soon as the risk of pulmonary embolism is passed. The risk of leaving in the filter outweighed the possible benefits said the FDA. Besides a filter migrating, fracturing or perforating, there are additional risks of an IVC filter tilting on its side making them useless as a device to catch blood clots.

And Boston Medical Center found, even with the filter in place, there were 25 pulmonary embolisms that occurred with the IVC filter.

Despite those warnings, more than a quarter-million filters are implanted every year and up to 70 percent of the retrievable variety are left in place permanently.

Since removal of her IVC filter is considered risky, Wendy has the only option left to her, to remain on blood thinners for the rest of her life. She has filed a $200 million lawsuit against Cook Medical over its inferior vena cava filter and the loss to her quality of life. #

Sources: http://ivcfilterresourcecenter.com/wp-content/uploads/2013/11/Indications- Complications-and-Management-of-Inferior-Vena-Cava-Filters.pdf; http://evtoday.com/2010/02/when-temporary-ivc-filters-become-permanent/; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4045516/

Still Ahead

Fair Warning- Child Safety Seat regulations flawed

Regulators, Automakers Urged to Warn Parents About Flawed Seats

Weston Kingsley died in February 2014 when his car seat when his father’s minivan seat collapsed backward crushing the boy during a rear collision. The auto industry is aware many auto seats can fail in these collisions.

Plan to protect workers from Silica dust

After Long Delays, Feds Unveil Tougher Rules to Protect Workers From Silica Dust

Occupational Safety and Health Administration has new standards to protect workers from silica dust which comes from pulverized stone.

Actos raises Bladder Cancer Risk?

http://www.philly.com/philly/health/topics/HealthDay709521_20160331_More_Evidence_Dia betes_Drug_Actos_Raises_Bladder_Cancer_Risk_a_Bit.html

A British Medical Journal study on the diabetes drug Actos links it to an increase in the risk of bladder cancer.

Can One Drive and Read a Distracting Billboard?

Evidence Mounts of Distraction Risks from Digital Billboards Along Roadways

A roadway researcher says billboards that contain digital information lead to distracted driving.