Among the most popular modern buzzwords, up there with “millennial” and “leadership” is “transparency.” Especially with the dense thicket of jargon that surrounds the medical industry and political sphere, more and more individuals are calling for transparency regarding where money is coming from and going and who has a say in that movement. Of course, the field of pharmacogenomics is no different. With the importance of the data being handled and the technicalities of what happens, it’s absolutely urgent that clinics are open and transparent about what they’re doing with the money and data they have.
The US Department of Justice made an example out of a clinic that failed that remain honest and transparent regarding the whereabouts of its money. Noting a violation of the Anti-Kickback Statute, the DOJ settled for $3.5 million against Primex Clinical Laboratories and fined its CEO an additional $270,000. Two whistleblowers who were former employees of the company alerted the Justice Department as to the issues occurring at the company.
In the 1970s, Congress passed the Anti-Kickback Statute as a prevention measure against fraud against the US healthcare system. The statute explicitly prohibits any laboratory from offering doctors “remuneration” for patient referrals to keep everyone in the industry honest. Without the statute, Congress anticipated that clinics and other medical labs would pay doctors to send patients to them.
In the case of Primex Clinical Laboratories, the executives skirted the laws and offered cash incentives for doctors to send their patients’ DNA their direction, and offered an additional bonus if the DNA turned up anything of interest. After a thorough investigation, the DOJ decided that the incentives were against the law, and today, they’re paying a hefty fine as retribution.
It’s important to run a medical laboratory with the precision, accuracy, and respect for the law that’s necessary for a place of business and a place of repute. Transparency in procedures, finances, and legal matters is imperative to ongoing positive relationships with doctors, patients, and regulators.
As more local and state governments relax their policies on the usage of marijuana for both medicinal and recreational purpose, the science has struggled to keep up. Long-held embargos and ethical objections have stopped scientists from performing scientifically rigorous tests on the effects of the drug on various people given their maladies or complaints.
To skirt policies, some scientists have performed their research in a makeshift lab on wheels. Colorado’s state government has fully legalized the use of marijuana for any purpose, but a 2014 federal law prohibits scientists from performing research on the effects of the drug with anything except federally-grown weed. In theory, the law was supposed to help uniformize all tests and keep confounding factors from obscuring the test’s results. The problem, though, is that weed users don’t only use federally-grown pot, and as such, the findings may be generally useless anyways.
Recently, some scientists wanted to apply the logic and basics of pharmacogenomics to the study of marijuana. That is, it’s been long established that users’ reactions to various stimuli, including drugs, pain, and viruses are determined at least in part by their genetic composition. Sometimes, a single gene or a group of genes will direct the speed and thoroughness with which something like a chemical or an intruder is metabolized.
Some cannabis enthusiasts in Canada are claiming that they can harness the work that pharmacogenomicists have done in the past 50 years or so to tailor strains of the plant to certain genomic characteristics. That is, they can assess someone’s genes using the likes of 23&Me and grow a kind of cannabis that will best complement the person’s ability to metabolize. From keeping people from developing a dependence to helping them avoid the dreaded munchies that accompany a high, the geneticists who are championing tailored cannabis believe that they can use genetic markers to develop the best strain for a person.
Acclaimed pharmacogenomicists are nervous to cosign these claims. While they’ve made great strides in tailoring drug cocktails and dosages based on what a person needs and can reasonably handle, the promise of a perfect batch of marijuana for a person’s genome seems a little far-fetched at the moment. Hopefully, the science will progress to that level someday, but given the difficulty the field has run into already with safe and reliable genetics, it may be a ways into the future that this vision of individualized blunts comes to be.
With the advent in next-generation sequencing and availability of low cost genome sequencers, more information is available in regards to specific variations in genes. 2018 could see a rapid progress in filling the gaps that exist between bringing genomics and drug response into the same equation. Personal genome sequencers can be used to identify pharmacogenetic markers in an individual and this information can be used to determine what drugs will work best on that person.
As scientists identify more drugs with known gene variants that control the way a person responds to the drug, it opens a new frontier to personalized medicine and individual treatment plans. The result is further control over the side effects of drugs in patients and thereby better effectiveness of the overall treatment plan. Doctors will be able to provide the right dose of the right medication based on a person’s genome.
Advancement in clinical pharmacogenomics could result in the availability of more drugs with pharmacogenomics effects on the label. Currently, the United States Food and Drug Administration provides around 200 medications with pharmacogenomics information on the labels. Information on genotype-specific dosage and possible adverse effects on people with certain gene variants can help doctors determine more accurate prescriptions.
More research is needed in identifying new genetic variations and their interactions with medications. An expanded database of gene variants and their response to various drug components could be a highly valuable resource. Moreover, doctors and patients need easy access to genetic tests to find out how a person’s body will react to a certain medication. This requires proper guidelines on interpreting the results of genetic testing as well as more resources that help implement this in routine prescription.
Integration of pharmacogenomics in routine health care will need a lot of further research, but 2018 could mark the beginning of a more systematic approach towards design and development of new medicines based on genomics.
Hailing from North Palm Beach, Michael Harper is a highly accomplished business professional serving North Palm Beach, Florida, and Juno Beach, Florida. He has amassed over 15 years of experience within the areas of sales management, sales training, business development, and entrepreneurship.
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Over the past several years, Michael has begun to specialize almost exclusively in the clinical laboratory and diagnostic testing space. He currently serves as an Account Manager between clinical laboratories and healthcare providers. This line of work includes a variety of specialized blood testing, genetic testing, and much more. Michael Harper’s North Palm Beach and Juno Beach clients make up the largest percentage of his clientele, but the breadth of his services reaches all throughout Florida.
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Michael has truly enjoyed this new, exciting undertaking as it has been a pleasure to work in an environment where there is a constant and ever-growing need to deliver timely and precise testing results to patients and healthcare providers. As Harper contends, the healthcare industry is a “people” service. That is why Michael Harper North Palm Beach prides himself on going the extra mile for his clients, ensuring that each patient gets the best possible care available. In laboratory testing, there is nothing more important than delivering accurate results and superior service to the physicians and providers.
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Michael Harper is excited about what the future holds for the healthcare industry, specifically laboratory testing. He has been privy to the factual evidence that shows the industry is on the cusp of some incredible breakthroughs that will forever change the way we perform laboratory testing. As more doctors and scientists find their way down to Florida, more developments that will keep individuals from succumbing to addiction will find a market.
For healthcare providers and patients alike, the level of efficiency and effectiveness is nothing shy of impressive. Michael Harper North Palm Beach has already begun to see many of these changes take place. For years, blood tests have required six tubes of blood to be drawn. Nowadays, Michael is beginning to see the rollout of FDA-approved blood tests that require nothing more than a finger prick. This is just one example of the many revolutionary changes that our currently in development and soon to be introduced to the public.
Outside of his professional endeavors, Michael Harper’s North Palm Beach ties make him a dedicated philanthropist who cares deeply about supporting and giving back to the community. He credits his faith as the driving force behind his commitment to philanthropy. While he supports a wide range of causes, Michael is most passionate about St. Jude Children’s Research Hospital and the Christ Fellowship Church in Palm Beach Gardens. When it comes time to relax, Michael enjoys taking advantage of all that the great state of Florida has to offer.