Did You Know?

While dieticians, nurse practitioners, physician assistants, nurse midwives, and clinical social workers are recognized as healthcare providers under the Social Security Act, pharmacists are not, despite overwhelming evidence of their positive impact on patient health.

Change.Org is hosting a petition to correct this crucial oversight in healthcare policy.

Learn more and weigh in at: http://chn.ge/OyZcOS

Personalized Medicine May Fuel Economic Growth

The concept of personalized medicine isn’t new, but the public awareness campaign is only just picking up momentum, partly on the heels of the Patient Protection and Affordable Care Act (PPACA). While the overhaul of the American healthcare system is surrounded by considerable debate, biotech companies are finding fresh optimism in bringing the science of pharmacogenomics into the mainstream.

Though physicians and pharmacists are just beginning to adopt gene-based prescribing, it has already caught the eye of Eddie Yoon, a research analyst for Fidelity Investments and the company’s health care fund manager.

“We are entering the era of Biotech 2.0, in which targeted diagnostic tests are accelerating advances in the truly life-changing therapies of personalized medicine,” according to a recently published Fidelity Viewpoint article. “With an estimated 90% of prescription drugs working only about 50% of the time, prescribing physicians could use molecular diagnostics to test for specific genetic mutations that might cause one drug to be harmful, while another might be safe.”

Fidelity considers genetic-based medicine regimes a game-changing innovation that can drive considerable growth in the health care sector. And at a current estimate of 770,000 injuries and deaths from adverse drug reactions, Fidelity suggests,“this could not only save 50% of drug costs, but also help prevent a leading cause of unintended death.”

All this suggests that the cost savings introduced by personalized medicine and genetic-based prescribing practices might well become the prevailing catalyst to an entirely more patient-centric approach to healthcare. □

Whether it will be improved patient care goals or impressive profit-and-loss ratios that fuel the move to personalized medicine, all indicators point to a win-win scenario.

Source:  https://www.fidelity.com/viewpoints/personalized-medicine-revolution

Codeine For Kids? FDA Says Maybe Not

On August 15th, 2012, the FDA issued a Drug Safety Communication cautioning against the use of codeine in children following surgery. Four recent cases of severe adverse drug reactions prompted this communication.

In these cases doctors used the opioid narcotic codeine as a pain-killer following nose and throat surgery in children suffering from sleep apnea. Their ages ranged from 2-5 years old. All of the children received normal doses of codeine, however, respiratory symptoms developed within two days of starting the regimen. Three of the four cases proved fatal. 

Evidence suggests that all four children possessed the CYP2D6 Ultra-Rapid Metabolizer phenotype. Enzymes within the liver naturally convert codeine into morphine. However, in these particular cases the children’s livers would have converted the codeine more rapidly than expected, leading to dangerously high blood-morphine levels.

Recent studies have shown some aspects of opioid sensitivity (including decreased respiratory rate, sedation, and addiction risk) can be genetically inherited. It’s estimated that 7% of the population possess the aforementioned Ultra-Rapid Metabolizer phenotype, although its estimated to be as high as 29% of North African and Ethiopian populations.

Conversely, individual genetics may also cause opioids to be processed more slowly than expected. The FDA reminds readers that the only way to know if someone is an Ultra-Rapid Metabolizer is to do a genetic test that determines an individual’s CYP2D6 phenotype.

Codeine, along with other related opioids such as methadone and oxycodone, forms a cornerstone of advanced pain management, and is also used as a cough suppressant. Adverse reactions to codeine typically manifest as sleepiness, confusion, or breathing difficulty. Nausea is also common, affecting approximately one out of every three patients taking codeine post-surgery. Even non-serious side effects can be problematic, extending hospital stays and increasing likelihood of readmissions.

The FDA is currently investigating to determine if additional cases of severe adverse drug reactions have occurred in children. They advise healthcare professionals to be conservative in their prescribing regimens and remind parents to monitor their children’s health for any adverse drug reactions whenever taking new medications. □

Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm315497.htm

Washington Family Reunited

The Republic of the Union of Myanmar has been in political and economic turmoil for decades. Formerly known as Burma, the country had been under military rule until the beginning of 2011.

In 2008, Aum Phe attempted to smuggle his family out of the country, to escape religious persecution. Though he and his wife were able to get out of the country, Thailand border agents discovered the van transporting their five children and sent them back to Myanmar.
 

Since their separation, Aum and his wife, Shwe Pai, have been living in Washington state where he had, at least, found peace tending his backyard garden.

All of that changed on the night of Tuesday, July 18th when the couple’s children landed at the Tri-Cities Airport in Pasco, Washington. The children were greeted with hugs, strawberries, and bottles of Sprite and Coca Cola.

The two boys and three girls range in age from 7 to 16 years old. Om Phe, the oldest son, is now nearly as tall as his father. Speaking through a translator, Aum Phe, thanked everyone who made the reunion possible.

Before escaping, Aum Phe had to work for years to save enough money to get his family out of the country. He worked in India and Malaysia, taking whatever work he could find, including working for a pig farmer, where he slept in a field inside a makeshift tent made of newspapers and plastic tarps while earning little to no money.

When his children were prevented from fleeing the country, he had to bribe border agents to learn where they were and again to buy the release of his children, so they could return to their uncle’s farm.

Fortunately, Aum Phe’s story is uncommon with fewer than 6 percent of families becoming separated during their relocation, according to World Relief. The process to reunite the family took years of paperwork, an immigration attorney, DNA relationship testing, and a lot of worrying.

Over the years, the Phe’s sent money to Myanmar for their children to rent a home and for the two oldest to go to school and take English lessons. Now they look forward to sending all their children to school, and if all goes as planned, Aum wants to send Om Phe, 16, to college, and maybe take classes himself. □

FDA Reaffirms Plavix Black Box Label Decision

The US Food and Drug Administration (FDA) is standing by its original decision to update the Plavix label with pharmacogenetic information. A meta-analysis published last year in the Journal of the American Medical Association led by Michael Holmes of the University College of London, raised questions about whether the label changes were premature.

The FDA black box warnings are the strongest type of printed warnings put on prescription drugs. Many pharmaceutical companies and physicians believe black box warnings stigmatize a drug and lead to a decline in prescription rates. However, to date, there is no evidence of a meaningful relationship between the warning labels and any changes in demand.

The CYP2C19 enzyme converts Plavix into its active form. Pharmacogenetic testing identifies the amount of the enzyme a person creates and assigns a value ranging from poor to rapidmetabolizers. The FDA updated the label to inform doctors that poormetabolizers experienced a diminished response to the drug. In 2010, the FDA added the black box warning to highlight that poor metabolizers exhibited a higher cardiovascular risk following acute coronary syndrome or percutaneous coronary intervention (PCI) than normal metabolizers. Both warnings emphasized that pharmacogenetic tests could help guide therapeutic strategies, with the black box advising doctors to "consider alternative treatment strategies" in poor metabolizers.

Holmes et al noted “evidence of small-study bias” in the data collected by the original meta-analysis, and restricted their analysis to only four studies with 200 or more events. These four studies, plus six randomized trials, failed to identify any significant associations between CYP2C19 genotypes and Plavix efficacy in terms of cardiovascular events and bleeding.

According to Lawrence Lesko, former director of the Office of Clinical Pharmacology at FDA's Center for Drug Evaluation and Research, emerging data has shown that the FDA was right in updating the Plavix label. He noted that two other meta-analyses, published before the Holmes et al study, found that poor metabolizers were at heightened risk for cardiac events. Jessica Mega, a cardiologist at Brigham and Women’s Hospital authored a meta-analysis two years ago reporting Plavix-treated patients who were poor to intermediate metabolizers had a “significantly increased risk of major adverse cardiovascular events, particularly stent thrombosis.”

Scripps Health Chief Academic Officer, Eric Topol, has repeatedly argued that CYP2C19 pharmacogenetic testing is most useful in patients who have undergone PCI and are at risk of stent thrombosis. Many agree that these studies have been positive and that the resulting dialogue continues to be extremely valuable to doctors and patients. Ultimately, conversations like the Plavix/FDA debate continue to underpin the value of pharmacogenetic testing in treatment strategies.  

Did You Know?

More than 50% of the most commonly prescribed drugs are processed by enzymes whose levels vary due to genetic factors. This genetic variability is a leading cause of adverse reactions.

There are over 2 million severe adverse drug reactions every year.

Every day more than 5,000 Americans have  an adverse drug reaction serious enough to require hospitalization.

In 2001, the direct healthcare costs associated with adverse drug reactions were estimated at $177 billion.

Personalized Prescribing in Action: Case Study

You don’t need genetic information to benefit from YouScript™!

A 62-year-old male doctor whose health conditions, at the time, included hyperlipidemia, erectile dysfunction, dental carries, and insomnia. His daily medications consisted of aspirin, Lipitor, Viagra (as needed), and chlorhexidine mouth rinse, also valerian root, melatonin, and Benadryl for sleep. Along with coffee and energy drinks, the subject had been taking over-the-counter medications including: fish oil, coenzyme Q10, Niacin 1000mg, L-carnitine, Voltaren gel (purchased from Mexico) and IBU 400-600 mg daily as needed for need pain. He had no known drug allergies.

His ophthalmologist instructed him to start taking the over-the-counter herbal medications Wobenzyme, red yeast rice, curcumin powder, and grape seed as supplements.

Soon after adding the supplements to his daily regimen, the doctor began to experience muscle aches, pains, and flu-like symptoms.

Unfortunately, the ophthalmologist had advised the doctor to take substances that interacted with the prescribed medications he was taking. The interactions were severe and based on the report may have been early signs of rhabdomyolysis.

Had either the doctor or the ophthalmologist utilized YouScript™ prior to initiating the OTC herbals, they would have seen the following interactions:

·         Red yeast rice contains the compound lovastatin which is in the same class of drugs as Lipitor. The subject was already on high dose Lipitor. This combination alone could have resulted in the adverse reactions described. This combination is not advised.

·         Levels of lovastatin may be increased up to 150% by grape seed due to 3A4 inhibition. Levels of Lipitor might also be increased but to a lesser extent. This interaction could also help explain the adverse reaction the patient had.

·         Clinical studies show that co-administration of niacin and lovastatin has been found to increase the risk of rhabdomyolysis. The lovastatin product insert recommends no more than 20 mg daily when niacin levels exceed 1 gram per day – however, since the patient was taking lovastatin in a non-standardized form, it is unknown how much he was truly receiving.

Once the doctor stopped taking the drugs and herbal preparations recommended by his ophthalmologist, the problems resolved.

You don’t need a patient’s genetic information to benefit from YouScript™. It is a powerful algorithm-based program that can help patients and practitioners predict clinically significant drug interactions before they happen. YouScript™ predictions are based on clinical studies and the most up to date expert opinions in the field.