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Farah & Farah May 2016 Newsletter

Posted on May 2, 2016

Opioid Abuse in the US Highlighted by the Death of Prince

With the April 21 death of music legend, Prince, the story about his alleged prescription drug abuse is slowly emerging. While the official cause of death of the 57-year-old entertainer is not yet known, the Wall Street Journal reports Prince had the prescription opioid, Percocet, in his possession when he died. Prince was given Narcan, a drug used for opioid overdose, days before his death. Other reports say he was highly addicted to pain killers Dilaudid and Fentanyl.

The U.S. Drug Enforcement Administration (DEA) is reportedly looking into the official cause of death as well as law enforcement in Minneapolis where he lived. 

Prince reportedly suffered pain from ongoing hip problems, which would partially explain his use of a cane. The Today Show reports Prince needed a double hip replacement, but remember, he was a practicing Jehovah’s Witness. Followers do not believe in blood transfusions which might be necessary during any surgery.

A hip replacement has its own host of problems. Many artificial hips fail creating need for revision surgery. Metal-on-metal hips have been known to leave metal toxicity in the body. If he already had a hip implant, pain is also a symptom of a failing hip prosthesis. We do not know if he needed hip surgery or already had it.

The use of opioid drugs is at a crisis level, according to data from the Centers for Disease Control and Prevention (CDC).  Since 2000, the number of prescription overdoses of opioids has quadrupled. 

Opioids work on the opioid receptors. Morphine and heroin are drugs derived from opium.  Other opioids are synthetic such as oxycodone, fentanyl, and hydrocodone. Percocet is a synthetic opioid, usually taken as a tablet that contains paracetomol and oxycodone.   The more you take, the more your body requires as it becomes tolerant of the dosage which also contributes to addiction. 

The CDC reports in 2012 there were an estimated 259 million prescriptions written for opioid pain medication, used for chronic pain defined as lasting three months or past the time of normal healing. That is enough for every adult in the U.S. to have a bottle of opioid medication.  In 2014, there were 28,647 fatal overdoses from opioids which can depress the respiratory system.

While opioids are largely prescribed for the pain from cancer, that is changing. Prescription rates increased 7.3 percent from 2007 to 2012 for family and general practice internal medicine when compared to other specialties.   Death rates have been noted among chronic non-cancer pain patients. A recent study of those patients followed for 13 years found one in 550 patients died at a median rate of 2.6 years from the first opioid prescription.

To deal with the overprescribing of opioid medication, last March, the CDC issued new guidelines for prescribing opioids for chronic pain.  These suggestions include prescribing only when there are nonpharmacologic therapies involved; with the lowest dose medication that is still effective; with effective pain treatment that may include physical therapy and with follow-up patient evaluation. 

The CDC concludes that the risk of opioid abuse far exceeds its benefits, which may be a tough sell to someone who is addicted and suffering chronic pain. #

Sources:  http://www.thedailybeast.com/articles/2016/04/22/prince-died-in-an-elevator-at-home-cause-still-unknown.html;   http://www.people.com/article/prince-took-percocet-pain-performing;   http://www.wsj.com/articles/authorities-probe-drugs-found-on-prince-at-time-of-death-1461872272;   http://www.chicagotribune.com/suburbs/arlington-heights/community/chi-ugc-article-new-cdc-opioid-guidelines-say-physical-therap-2016-04-12-story.html;   https://en.wikipedia.org/wiki/Opioid

Metal Hip Implant Failures May Be Due to Manufacturing Variation

A study published this week blames the failures of many metal-on-metal hip implants on manufacturing defects. 

MoM (metal-on-metal) hips, as they are known, were supposed to be the latest trend in improved artificial hips. They were marketed to a younger generation who would need the hip prosthesis for many more years and were generally more active.  Marketing showed tennis players allegedly with artificial hips made of metal components.

That is not the way the promises turned out.

MoM hips led to early revisions and metal toxicity in the blood from cobalt and chromium. Women seems to have a higher revision rate than men, 12 percent versus 7 percent, though it’s not known why.

Just last month Johnson & Johnson was ordered to pay $500 million in damages to five plaintiffs who claimed injury from the Pinnacle MoM implants.

The prosthesis is comprised of a femoral head. The acetabulum is the hip socket and part of the pelvis. The femoral head fits into the acetabulum becoming the hip joint where the ball rotates in the socket.

Trying to find a bottom line to the many MOM hip failures, investigators from University Hospital of North Tees, Stockton, United Kingdom focused on one of the most common MoM hips prostheses — the Pinnacle MoM 36-mm implant made by DePuy, a division of Johnson & Johnson with a Corail femoral uncemented stem. The implantations of 434 patients took place between 2003 and 2009 and they were followed up for 89 months. Of that number, there were 243 women and 191 men.

Published online in the British Medical Journal Open, the investigation combined explant analysis, blood ion concentrations and clinical data. The removal rate was “unacceptably high” with 71 metal hips that had to be removed and replaced. Among the failures, 70 percent showed evidence of taper-junction failure, 48 percent displayed bearing failure.

As was expected, there was a higher failure rate for women. Patients with two hip implants (bilateral) had a lower survival rate for the implant at 73.7 percent. A unilateral implant (only one) had an 86.2 percent hip implant survival rate.  Women had more than twice the number of bilateral hip implants.

A patient can only undergo so many hip replacements because the femur bone is severely damaged during the aggressive procedure.

The authors conclude that a significant number of the devices were manufactured out of the specifications. For example, the earlier MoM hip resurfacing prosthesis had a larger bearing diameter and the larger the head the larger the edge load and wear because of the contact pressure with the cup rim. Hips manufactured after 2006 had a clearance value lower that what manufacturers had stated to regulators.  The clearance between the articulating components played a major role in wear and the metal debris it generated.

For the female taper there were manufacturing differences and the finish of the surface appeared to be a critical factor in material lost in that junction. 

The U.S. Food and Drug Administration in February 2016 issued a final order requiring manufacturers to submit a premarket approval or PMA before marketing any MoM total hip replacement and moved them to a high risk category- Class III. Essentially any manufacturer will have to provide clinical trials to prove safety and that does not appear possible. As a result, the use of the MoM hip prosthesis is on the decline.

Still today about 500,000 patients have the troublesome hips in their body. Their long term future is uncertain.  The authors conclude that tens of thousands of patients will be at risk for early revision surgery largely because of taper failure and rising cobalt levels which need to be monitored by clinicians. #

Sources:  http://www.medscape.com/viewarticle/862707http://pic.sagepub.com/content/215/1/1.abstract;  http://link.springer.com/chapter/10.1007%2F978-3-642-03889-1_112#page-1;   http://bmjopen.bmj.com/content/6/4/e007847.full; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm

Risk of Miscarriage Increases with Drug Used for Yeast Infections
This warning is something pregnant women need to understand because getting a yeast infection during pregnancy is very common. 

The antifungal drug, fluconazole, may carry a risk of miscarriage. The warning comes from the U.S. Food and Drug Administration (FDA). Fluconazole is also known by its brand name of Diflucan made by Pfizer.  It is taken orally and is a tablet.

A recent Danish study highlighted the increased risk at a dose of 150 milligrams (mg), though it did not establish a definite cause and effect.

The Danish study was a large one. More than 1.4 million pregnant women were included in the study which stretched over 17 years. Of that group 3,300 women who took oral fluconazole during weeks seven through 22 of their pregnancy, suffered a miscarriage or spontaneous abortion. That number was compared to 563 women who suffered a miscarriage among more than 13,000 women who didn’t take the drug. There was no statistically significant link between the drug and stillbirths.

The study was published in the January 5, 2016 in the Journal of the American Medical Association (JAMA).

The label should carry such a warning but currently it only says a single 150 mg dose of the oral drug is safe during pregnancy.  According to the FDA safety alert a higher dose of 400 to 800 mg a day has been linked to birth abnormalities. Fluconazole is the only oral drug to treat yeast infections.

According to the Centers for Disease Control and Prevention (CDC), antifungal creams should be used instead to treat a pregnant women with a yeast infection. A vaginal suppository such as Monistat is usually the first line treatment, but a recurrent infection or severe symptoms might lead to a prescription for the oral variety.  Doctors need to heed this warning.   

This is not the first problem for oral fluconazole. Back in 2011 it was upgraded from a risk category C to a category D which indicates a potential risk to the unborn.

Drugmaker Pfizer, through a spokeswoman, told the New York Times that fluconazole has been used for 25 years and has a “well-established benefit risk profile supported by more than 25 years of patient experience.”  #

Sources: http://www.nytimes.com/2016/04/27/health/yeast-infections-diflucan-fluconazole-pregnant-women-fda.html?_r=0;   http://jama.jamanetwork.com/article.aspx?articleid=2480487;     https://www.nlm.nih.gov/medlineplus/news/fullstory_158503.html;   http://www.cbsnews.com/news/yeast-infection-drug-linked-to-miscarriage-risk/http://www.fitpregnancy.com/pregnancy/pregnancy-health/yeast-infection-drug-linked-miscarriage;   http://www.nbcnews.com/health/womens-health/yeast-infection-pill-linked-miscarriage-n490766

Still Ahead


Medical Errors Third Leading Cause of Death in US?
This study from Johns Hopkins and published in the BMJ says medical mistakes ae the third leading cause of death in the US right behind heart disease and cancer, at least 251,454 deaths annually.  This is a greater number than a 1999 Institute of Medicine study that estimates upward of 98,000 die from medical errors.
Sources:  http://www.cnn.com/2016/05/03/health/medical-error-a-leading-cause-of-death/


Public Citizen Tracks 25 Years of Pharma Industry Criminal and Civil Penalties
The consumer group finds from 1991 through 2015, Big Pharma settled 373 cases of wrong doing against the federal and state government for a total of $35.7 billion. Pharmaceutical companies were fined for drug pricing fraud against Medicaid and Medicare, as well as the off-label promotion of drugs. Whistleblower or Qui tam cases were responsible for 81 of 140 federal settlements for $22.8 billion. GlaxoSmithKline and Pfizer paid 31 settlements each for $7.9 billion and $3.9 billion.
Source: http://www.citizen.org/documents/2311.pdf

CDC Study — Play yards lead to traumatic head injuries
Source: http://pediatrics.aappublications.org/content/early/2016/04/28/peds.2015-2721;  
http://www.techtimes.com/articles/155576/20160503/more-us-kids-suffer-head-injuries-at-playgrounds-how-to-ensure-playtime-safety.htm

Farm Animals and Antibiotic Resistance Threat Warning
As frightening as it sounds a health regulator in the UK says millions will die from antimicrobial resistance to antibiotics and by 2050 it will represent a greater threat to health than cancer.
Source: http://www.theguardian.com/society/2016/apr/14/antimicrobial-resistance-greater-threat-cancer-2050-george-osborne?CMP=share_btn_fb#_=_

Fair Warning- Child Safety Seat regulations flawed
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.
Source: http://www.fairwarning.org/2016/03/flawed-seats/

Plan 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.
Source: http://www.fairwarning.org/2016/03/osha-silica-dust-exposure/

Actos raises Bladder Cancer Risk?
A British Medical Journal study on the diabetes drug Actos links it to an increase in the risk of bladder cancer.
Source:  http://www.philly.com/philly/health/topics/HealthDay709521_20160331_More_Evidence_Diabetes_Drug_Actos_Raises_Bladder_Cancer_Risk_a_Bit.html

Can One Drive and Read a Distracting Billboard?
A roadway researcher says billboards that contain digital information lead to distracted driving.
Source: http://www.fairwarning.org/2016/03/digital-billboards/

Second Toxic Talc Award for Plaintiffs $55 Million
http://www.latimes.com/business/la-fi-talcum-powder-cancer-20160503-story.html

Chinese Mesh Questions Going to Grand Jury
http://www.legalreader.com/boston-scientific-faces-criminal-investigation-over-counterfeit-mesh/