In providing readers with factual and reliable information about healthcare technical advances based on research within trials, and how that affects your medical dollars out of pocket, it will be a force to be reckoned with. Newer healthcare laws this decade have given systems that were in places that had flaws led to fraud and abuse which CMS is strongly heading forward on prosecutions and waging war on hackers that steal and use information against those that own that data.
Money that has been invested in making medicine more readily available and testing advances for millions that would otherwise be misdiagnosed, the medical science communities are pushing for studies that are reliable and trustworthy with the data collected. In examining this reconstruction that is necessary with the ensuing ICD-10 roll out, we have to know that the previous fractured system just will not do.
In the case of how clinical trials report finding, we have broad categories of reporting. Large multi-tiered entities that fold our medical financial woes hand in hand with medical research and results that is reliant on honest reporting, and professionals that have forthrightness to write distinct and clear information in the clinical submissions where that is based on data that is reliable.
Hearing from the experts:
The sources that produce garbage data where in turn the information created is skewed are hidden culprits. The industry of “clinical and medical device trials” should not be in the business of finding cures for people in general terms, they should be able to field issues that create really heated discussions like the recent article I commented on LinkedIn on the Aug 27th, where a reliable doctor has blown out the trial data as valid and the lid to that kettle blowing off hasn’t hit the ground yet!
Dr. Richard Horton, Editor-in-chief of the Lancet, had this to say about the data that scientist and big pharma rely on everyday…”Much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”
The Redirected Health Care spoke of is in reference to a book written by in accordance with the Bill and Melinda Gates Foundation , where one of the goals was for this study to be focused on changing which medical products get invented in the first place.
In the Preface to the text book REDIRECTING INNOVATION IN U.S. HEALTH CARE Options to Decrease Spending and Increase Value, I sought out a “reliable source” to retrieve Health Informatics medical technology research that had no slant! The paragraph is as follows:
Many experts identify costly new technology as the biggest driver of health care spending. Previous studies aimed at reining in spending on technology have considered changing how existing medical technologies are used. In contrast, this study focused on changing which medical products get invented in the first place. The goals were to encourage creation of medical products that could improve health and reduce spending or that provide large enough health benefits to warrant any extra spending.
The study argues that the most powerful way to accomplish these goals is to realign the financial incentives of inventors, investors, payers, providers, and patients by changing the costs, risks, and rewards anticipated at various stages along the pathway from invention of a medical product to its adoption in the U.S. market. The study suggests policy options that could point the way toward achieving that realignment. The study should be of interest to health care industry experts, drug and device inventors, regulators, payers and insurers, venture capitalists, health policy experts, legislators, and researchers.
Full spectrum of medical research:
In this explanation of what a redirection in the medical environment to the a fore mentioned and how realignment can affect the convoluted medical system in it’s entirety. If the list of those in those industries and are reading this article, having that audience should direct some attention to the data in trials, if redirection in this manner is to be fruitful. It must include the dollars spent in R & D, since the basis for clinical trials is to test phases on humans after sufficient study, the main problem with studies is they tend to slant one way or the other; especially in cases where the sponsorship is by the a drug/device/procedure creator or company and the data is then supplied by the company that is making the drug, conducting the trial and those that are examining the evidence compiled afterwards, would that invalidate the data? Is that still considered a blind study?
Inventors of drugs, devices or procedures that use the venture capitalist’s to throw money at them because the cost for newer technology to make drugs to apply to new health care, have sky rocketed, industry experts back those inventions to a miracle drug, in hopes it leads to cures, the goals of the makers; in many fields it is getting harder to convince due to clinical trial hurdles the FDA imposes.
Skewing results can be drawn out of any study in my opinion. It depends on so many factors, many of which are highly regulated and certainly over time whistle blowers have taken a stab at the multitudes of scientist, manufactures, supplier that have fudged on ingredients to save money; in the medical industry there are taboo’s to make Billions off the sick and dying, where the object was to provide a low cost solutions to the skyrocketing prices of trial drugs and then subsequently the marketing of those products to the general public since Geritol commercials started in the 50’s! As my mother couldn’t afford the trial drugs for her terminal cancer, where her take on having a terminal disease was, ‘if you stop you die!’ She broke that hip and passed less than a year later. If something stops you then yes trial drug or not you are going to succumb to the force of the nature of not living forever.
Most people don’t know what drugs they are taking, in the case of patient’s that take the doctor’s word for it (if they even see a doctor) they are taking medicines to relieve feeling bad, maybe went through blood test and was prescribed a statin, well if doctor or nurse only tells the patient the bare minimum after a drug has been marketed and is available to discuss with your doctor in layman’s terms provided the doctor knows enough about what they are prescribing and not based just on clinical trials that may or may not have had good data to derive it into information; additionally is it helpful to the masses? Paid for by individuals that pay premiums, entities that make up the web of insurance and billing interfaces across the U.S.
Redirecting all departments, where even in an electronic age things that continually “fall through the cracks,” enforces the fractured system where hackers, and thieves of all levels have infiltrated the integrity of the medical fields. Redirection must include the tweaks to the HITECH Act where it states emphatically that fraud and abuse will not be tolerated. Escalating technical costs to provide services that come with that technology should be bundled price and not a separate cost effect that is passed on to the patient. If in the field the trial information either yea or nay on the validity of information and outcomes that would mark the data and point to effective results or ineffective results.
To have a person like Dr. Richard Horton say that “half of all clinical trial data is wrong,” at best gives way to those the old adage “garbage in garbage out,” and as a long term computer nerd where watching the industries change to where all my computer expertise is now useful beyond the scope of careers previously for IT to chose from before the HITECH Act was created.
The sticky parts are that drugs or devices that had been passed by the FDA deemed safe to take or use an implant or a portable medical device where any number of things can go wrong, was based on stringent and verifiable reports that every piece of information is not left to question. We have to conclude the inventor, investor and the manufacturers that could report accurately the fail safe rate of any drug or device that is used on humans should have data to back that up.
Summary
The rest of the chain of the system that would be ” Redirected” according the authors of the book that is driven by Health Informatics and it’s innovations to Health Information Management offices across the country as people like myself with HIM type degrees move forward in this field of HIP, HIT professionals where necessary legislation be included in this sensitive and heavily debated subject. Keeping the patients safe during trials is more of a concern, as in the case of the lady in the video attached this story, where the data didn’t reflect what she reported during her time in the trial. After she didn’t complete the trial, does that make her data not part of the study other than she didn’t finish the study? The medical infrastructure should be made more astute to change and advancements as HIT moves farther from center and gets yet other advancements that will affect entities in the long run where every single element in medicine with it’s technologies specific to each and every field where all are based on information from a trial or study, hypotheses about the data being projected to anyone who wants to find it like the general public can go to this link: https://clinicaltrials.gov/ to investigate all the trials that are being accepted are not being accepted and terminated, of those under the “drug” category there were 127232 studies where this site has the recruiting status of the trial in question.
Lists of patients that have suffered then had to deal with abasement once they voiced the trial didn’t work or a device has malfunctioned where the rules of the trial obviously sidestepped in the video of the woman as she reported tearfully in her case the medical device seemed to have failed upon installation. The trial produced results, the procedures sent to final development phases, monitored by the FDA who is the governing body behind all these technological advancements where “processes” are developed by the FDA to make baseline decision on approval or rejecting that drugs based on those results and the efficacy, device or procedure that could shape the future of medical invention, is lacking that substantial proof. The investors and legislators all playing their part in the next decade under a new President for the first time in eight years where our Redirecting Innovation in U.S. Health Care is the next most important job the new President will have.
In the beginning of my research on this subject where subsequent evidence pointing to the scientific research industry that may have set the entities in the medical financial world into current circumstance where cost balance for the FDA to speed up the process isn’t feasible, as the FDA states in the reference text, that these “processes” that the study funded by the Gates Foundation where Dr. Horton may have grounds for his suspensions. Where I still have my qualms about saying “all research is skewed where half is wrong.” As I stated on the LinkedIn discussion there is no substitute for human compassion, there should be a status quo and one that can’t be violated.
In the last element from the resource for this article the caution the FDA moves with is undeniably feeble, on the other hand it is also eloquence in that is has a job to do that won’t make every single drug, medical device and medical procedure inventor happy, but they have a nasty job and it is cited it the reference pages they do a pretty good job of it. Still the industry critics say the FDA is “too” strict and the balance should be equal between risk and benefits for the product being approved. There are some short cuts like user fees and quick approvals could lead to post-marketing safety problems.
