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Farah & Farah January 2016 Newsletter

Posted on January 9, 2016

FDA- Slow to Act on Transvaginal Mesh Restrictions

It’s been five years in the making. The U.S. Food and Drug Administration (FDA) has finally put into place a rule to make it tougher to sell and market polypropylene mesh used to treat pelvic organ prolapse or POP.  Many people consider this to be progress, and it is a small step, but consider how long the federal safety agency has taken to act and how far it has yet to go.

An expert panel convened by the FDA in September 2011 decided there should be tougher restrictions on the mesh used to treat POP, a condition where muscles and ligaments fail to support pelvic organs. Prolapse can be so bad that a woman’s uterus, bladder or even intestines can literally hang below her pelvic floor and outside of her body.

Specifically the panel decided POP mesh safety “is not well established and that, depending on the compartment, placement of surgical mesh for transvaginal POP repair may not be more effective than traditional “native – tissue” repair without mesh.”

POP mesh is a large piece of polypropylene mesh, about the size of a hand, that comes precut in a box (one size fits all) along with trocars or stainless steel hooks to place it deep and permanently into the body.  There are about 70,000 of these surgeries and surgeries using smaller mesh to treat incontinence performed on American women a year, according to the FDA.

To underscore just how ineffective our safety watchdog is – companies that make mesh including Big Pharma’s Johnson & Johnson and Boston Scientific – will have 30 months to prove to the FDA the product they are already selling is safe and effective.  A bit backwards, no?  Americans expect products put on the market have been tested for safety before they are marketed, not afterward. 

What’s left out of this much-delayed new rule is the smaller transvaginal mesh used to treat stress urinary incontinence or SUI.  The FDA has left it in a class II or moderate risk classification, while the larger POP mesh will be moved, in almost three years, to class III or high risk, where it belonged in the first place. How could a permanent implant made of plastic that has gone untested and is the subject of 100,000 lawsuits be anything else but high risk?

Additionally, the trocars, or giant Captain Hook like claws that place the mesh, will undergo another safety panel review, February 26, 2016 to decide whether they too, should be reclassified as high risk. It is not uncommon for a surgeon to nick an organ during the blind placement of mesh through a transvaginal, or via the vagina, surgery. 

A high risk classification means that like drugs, the companies will have to prove through clinical trials that a product is safe and effective before it is marketed. 

As it stands now, any moderate risk medical device manufacturer must submit paperwork to the FDA stating their product is the “substantial equivalent” of a device already on the market.  With a few thousand dollars and an exchange of paperwork, you have a medical device approval. Most Americans do not know that more than 90 percent of medical devices make it to market under the 510(k) fast-track approval process, including permanently implant devices such as pelvic and hernia mesh. 

If you are to have a medical device implanted, be sure to inquire whether it has a 510(k) approval number within the FDA.  If so, understand that you will be part of the post approval real-life testing of a medical device.  #

Sources:  https://www.gpo.gov/fdsys/pkg/FR-2016-01-05/html/2015-33165.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery;
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm; https://broadly.vice.com/en_us/article/fda-finally-recognizes-that-transvaginal-mesh-puts-women-at-a-painful-riskhttp://www.wsj.com/articles/fda-tightens-rules-for-mesh-device-used-in-some-pelvic-surgeries-1451932792

Benicar Trials to Begin Late 2016

It is a widely prescribed drug given to treat high blood pressure. With an estimated one in three Americans afflicted with this condition, Japanese drugmaker Daiichi Sanyko knew it had a potentially lucrative market when it received Food and Drug Administration (FDA) approval for Benicar in 2002. The drug soon became a blockbuster for the company which also has U.S. headquarters in Parsippany, New Jersey.

But there is a specific problem with Benicar which is emerging and the focus of intense litigation.

Benicar is facing about 1,100 lawsuits with the numbers growing all of the time. Now multidistrict litigation has been centralized in Camden, New Jersey in the U.S. District Court there. The first bellwether or test cases should be heard later in 2016. It’s predicted thousands of cases will be filed over the controversial drug.

Plaintiffs complain that Benicar causes them to develop chronic diarrhea and other gastrointestinal distress.  With attacks of up to 10 to 20 times a day not uncommon, many plaintiffs lost considerable weight and had to be hospitalized.  Internally, the drug has been shown to flatten the villi in the intestine, making it unable to digest food.  The condition is known as sprue-like enteropathy and it can lead to malabsorption and malnutrition.  The symptoms may take two years to develop and some of these changes are permanent. In some cases patients have died.

The product label to warn of sprue-like enteropathy was updated in July 2012, 11 years after the drug was launched.

Product liability actions will attempt to determine what the company knew before it marketed this drug and what its reaction has been as these adverse events are reported.  That’s where discovery comes in.  Both sides get to request and hopefully receive internal company documents that will show what executives, scientists, sales reps and the marketing divisions were discussing prior to and during the launch of the drug. 

Some of the documents have already been produced to the Department of Justice which required Daiichi pay a $39 million settlement based on False Claims Act violations. The money will repay Medicaid programs after the DOJ determined the company paid kickbacks to doctors to induce them to prescribe Benicar and its other drugs Azor, Tribenzor and Welchol.  The Anti-Kickback Statute regulates these payments and assures doctors are not induced by dollars for lavish dinners, speaking engagements or lucrative consulting agreements.

A former sales rep blew the whistle on the company and will receive a portion of the monies recovered. #

Sources:  http://www.njlawjournal.com/id=1202738704792/With-Suits-Climbing-First-Benicar-Trials-Set-for-Late-2016-?slreturn=20160006084814#ixzz3tvnnNmA9;   http://www.justice.gov/opa/pr/daiichi-sankyo-inc-agrees-pay-39-million-settle-kickback-allegations-under-false-claims-acthttp://www.aboutlawsuits.com/wp-content/uploads/2015-10-30-Order.pdf

Monsanto’s Roundup Herbicide Likely a Cancer Causer

The news is shocking because the weed killer, Roundup, is such a common product found in many American homes. 

The World Health Organization (WHO) says the main ingredient in Roundup “is probably carcinogenic to humans.” The WHO’s International Agency for Research and Cancer (IARC), brought a panel of 17 reviewers from around the world to meet in Lyon, France in March 2015 to review the existing data on humans and animals exposed to agricultural chemicals known as organophosphates. The expert’s agreement was unanimous. 

The ingredient in question is glyphosate, the active ingredient in Roundup. It was put in a 2A category along with malathion and diazinon as “probably carcinogenic to humans.”  Tetrachlorvinphos and parathion were put in a 2B category or “possibly carcinogenic to humans.” 

A #1 category is “definitely” a cancer causer.

Glyphosate has been linked to non-Hodgkin lymphoma in humans in studies published over the last 15 years.  According to the Environmental Protection Agency (EPA), the chemical had a carcinogenic effect on lab mice.  Specifically, a rare type of kidney cancer was found in mice in a study the EPA reviewed.  This is what was alarming to the WHO. 

Monsanto and Roundup play heavily in the genetically modified organism (GMO) debate.  Roundup use has increased since the introduction of Roundup Ready crops – corn and soy primarily. When special GMO seeds, made by Monsanto, are planted, the field can be doused with herbicides and only the corn and soy remain standing. That’s because they are “Roundup Ready” or engineered to withstand the barrage of herbicide.  Unfortunately the use of Roundup has increased since the introduction of GMO seeds.  It’s found in air, water and food where it is sprayed, according to the WHO.

Also alarming — in humans living near fields where glyphosate was sprayed some people were found to have chromosomal damage. In California, glyphosate is listed as cancer causing under Proposition 65, designed to information the population of dangers in the environment. 

Increasingly, litigation is being filed by plaintiffs who were exposed to Roundup. While working as a grower’s assistant, Judi Fitzgerald says she could smell Roundup in the air as it was regularly sprayed both indoors and outdoors. She was exposed from 1994 to 1998. A doctor has diagnosed her with chronic lymphocytic leukemia. 

Another plaintiff claims that when he picked vegetables in Oregon, California and Texas from 1986 to 1995 he too was exposed to glyphosate. He’s been diagnosed with bone cancer.  These actions and others may result in a mass tort against Monsanto concerning cancers and glyphosate.

Monsanto’s response – The IARC excluded relevant scientific data and there is no established link between glyphosate and an increase in cancer.

Glyphosate has been on the market since 1974 and is used on corn and soybean crops primarily. It is also found in more than 160 countries.  Even though the patent for Roundup expired in 2000, it generated more than $4.8 billion in sales for Monsanto in 2015, reports Reuters. #

Sources:  http://www.huffingtonpost.com/2011/04/11/round-up-cancer-cause_n_847423.htmlhttp://www.scientificamerican.com/article/widely-used-herbicide-linked-to-cancer/; http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2970134-8/abstract; http://www.globalresearch.ca/monsantos-sealed-documents-reveal-the-truth-behind-roundups-toxicological-dangers/5476443;   http://www.nytimes.com/2015/03/28/business/energy-environment/decades-after-monsantos-roundup-gets-an-all-clear-a-cancer-agency-raises-concerns.html?_r=0; http://www.sourcewatch.org/index.php/Labeling_Issues,_Revolving_Doors,_rBGH,_Bribery_and_Monsanto;   http://www.reuters.com/article/us-usa-monsanto-lawsuits-idUSKCN0S92H720151015#V7p35XmRmDXcxDxk.97;  http://oehha.ca.gov/prop65/CRNR_notices/admin_listing/intent_to_list/090415LCset27.htmlhttp://www.ncbi.nlm.nih.gov/pubmed/10189142

Still Ahead:

JAMA on bicycle injuries
More Americans want to bike on city streets and elsewhere but hospital admission rate, especially among those 45 and older, shows it’s not always a safe alternative transportation.
http://www.npr.org/sections/health-shots/2015/09/02/436662737/as-more-adults-pedal-their-biking-injuries-and-deaths-are-spiking-too?utm_medium=RSS&utm_campaign=shotshealthnews

Teens who consume energy drinks more likely to be injured
http://www.personalinjury.com/blog/teenagers-sports-related-traumatic-brain-injury-most-likely-consume-energy-drinks

What Rockstar Energy Drink can do to your body
http://www.latimes.com/science/sciencenow/la-sci-sn-energy-drink-rockstar-heart-20151109-story.html;   http://jama.jamanetwork.com/article.aspx?articleID=2469194

According to researchers at the Mayo Clinic, a single can of Rockstar energy drink raised blood pressure and can incite your fight or flight hormone all within 30 minutes. A single 16 ounce can has 240 mg of caffeine and 2,000 mg of taurine. Also included is guarana seed, an energy booster, ginseng root and milk thistle extract. Mayo Clinic also served a placebo energy drink to 25 volunteers on another day. With an average age of 29, all were in good health and none were on medication.  Thirty minutes after consuming Rockstar their systolic blood pressure was up about 6 percent with about three additional beats per minute.  The real difference was in the nearly doubling of the amount of norepinephrine after drinking Rockstar. The precursor of adrenalin, that is linked to cardiovascular.   

Popcorn lung disease tied to e cigarettes
http://www.newsweek.com/chemicals-flavored-electronic-cigarettes-popcorn-lung-disease-402565

Environmental Health Perspectives is reporting that a flavoring compound added to Electronic cigarettes is suspected of causing respiratory problems.

11 million Wright Metal Hip Implant Verdict
http://www.dailyreportonline.com/id=1202743733832/11-Million-Verdict-Could-Set-Example-in-Hip-Implant-Litigation?slreturn=20151103000546