Could the NYTs come up with a list of the political donations made by the large test and drug companies...............A
Pharmacogenetic testing is a valuable tool for many patients. In fact, there are over 120 medications approved by the FDA that reference pharmacogenetics in their labeling. Two common drugs, clopidogrel and codeine contain "black box" warnings that warn about the genetic differences of patients that may led to significant adverse events. Also, in Hawaii, California and other states, the respective AGs have brought law suits against the manufacturers of clopidogrel for NOT advising physicians on their patient's genetic predisposition that may affect their response to the medication. By doing these tests, those patients that cannot respond to clopidogrel can be identified and alternative treatments can then be deployed. Medication adverse events leads to over 100,000 deaths in the U.S. annually and an estimated 2 million people are admitted to the hospital because of them. This technology can significantly improve the quality of care, let alone overall healthcare costs for many Americans that struggle with the burden of poly pharmacy. As when anything new emerges, there is the possibility of abuse but it should not taint a worthwhile and important technology to improve the health of patients.
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I don't hear too many people talking about another aspect of this: privacy. It's not only medical companies who are hyping genetic testing; it has taken the world of genealogy by storm as well. Get tested to find out who your ancestors really were!
Think about this. When a private company has your DNA with your name attached to it, you have just handed over some very important and private information about yourself. It is possible this information could be used in the future in ways that are not in your best interest, or that of your descendents.
Of course, we are living in a world where Facebook has information on file that can make a facial identification of almost everyone in America under the age of 40. Why not give them your DNA profile as well?
Think about this. When a private company has your DNA with your name attached to it, you have just handed over some very important and private information about yourself. It is possible this information could be used in the future in ways that are not in your best interest, or that of your descendents.
Of course, we are living in a world where Facebook has information on file that can make a facial identification of almost everyone in America under the age of 40. Why not give them your DNA profile as well?
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If I were a betting man, I believe that the NYT will have another story to write on Dr. Kasirajan and Ally Clinical Diagnostics in a couple of years. Can probably just cut and paste the current article and change Renaissance to Ally Clinical.
This sort of mass-marketing of new genetic markers, without "compelling" evidence of effectiveness, reflects more economic than medical potential of the testing.
Dr. Jeter is absolutely right--Medicare should not be expected to pay for tests that have not been thoroughly peer-reviewed with unbiased studies and FDA-approval supporting their clinical usefulness.
There's much temptation to get a new test "out there", without due diligence to validate clinical reality that a specific genetic marker does really reflect the disease susceptibility or the drug sensitivity that is advertised.
Research grants, corporate funding, venture capital, etc. fund studies of a test or drug effectiveness, not Medicare payments.
Dr. Jeter is absolutely right--Medicare should not be expected to pay for tests that have not been thoroughly peer-reviewed with unbiased studies and FDA-approval supporting their clinical usefulness.
There's much temptation to get a new test "out there", without due diligence to validate clinical reality that a specific genetic marker does really reflect the disease susceptibility or the drug sensitivity that is advertised.
Research grants, corporate funding, venture capital, etc. fund studies of a test or drug effectiveness, not Medicare payments.
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Another set of greedy doctors has been feeding at the Medicare payments trough under all-but-fraudulent circumstances. I hope they get punished.
That this case involves individualized genetic testing is not surprising. The entire genetic medicine "revolution" is largely based on a few select cases where a particular individual's genetic profile fit with a particular medicine, and that person received what appears to be a "miracle cure". This occurrence is the Holy Grail of medicine, and its Wall St investors.
In truth, the genetic revolution has not born the sort fruit researchers 20 years ago thought it would because we still don't have a complete or total understanding of how our individual genes work in producing health and disease, and we won't any time in the foreseeable future because this area of human understanding is so vast, complicated, and yes, individually based. What works for you may not work for me.
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Pharacogenomic testing is a valuable tool in chosing the correct medication or dosage for the correct patient. The CYP450 gene has important isoforms that exhibit polymorphisms differing widely in the human population. The result is that some individuals need lower doses of certain drugs, others more. These polymorphisms explain many of the "side effects" we see in drug warning labels. The fact that Medicare doesn't want to pay for this testing, and that some unscrupulous individuals are abusing the opportunity to test appropriate patients isn't surprising. What is disappointing is that this article neither explores the benefits of pharmacogenomic testing not CMS motivation to end it.
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This is a classic case to illustrate why companies need to have well trained chief compliance & ethics officers on board as part of their management structure from day one - and that management needs to listen!
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The federal government, including FDA, has admitted that it really has trouble keeping up with the science and evaluating firms like companies such as Renaissance make for their products and research. It's not surprisng that FDA has taken such a long time trying to come up with regulations around genetic tests. As a result, the genetic testing field is completely vulnerable to shysters looking to cash in on the hype.
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Until health care is health care, instead of a profit model industry, fraud will continue to be rampant. Doctors perform unnecessary tests and can be bought for as little as $75.00 per patient. These stories pop up periodically. Again, the only way to contain health care costs is to have a single payer system.
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I came of age in the era of Dr. Kildare, and Marcus Welby, MD, fictional TV characters who reflected the art of medicine and its practitioners more than half a century ago. Notice I said "art" and not "science."
Science has supplanted art as the core, the heart, of medical practice. All things medical in this day and age must be "evidence based." The human being is viewed more in the light of a malfunctioning automobile engine that can be disassembled, reassembled, and fine-tuned many, many times, with the holy grail number being infinity, and with cost being immaterial.
Why anyone thinks they want to live much beyond the age of 75 or 85 is a mystery to me. Your skin is thin, with the tensile strength of wet Kleenex. Your hearing is, huh? Your vision is best described as "your lyin' eyes." Your contemporaries, you know, the ones who don't give you a blank stare when you say things like Jack Benny, Bob Hope, Bing or Frank (no last names needed) are dying, in the funeral parlor or already underground.
Today medicine is in danger of becoming, not about making every life a good life worth living without regard to its length, but about making a good living off of every life for as long that life can be tested extended and milked. Repeat as needed, if not more often.
We had a name for practitioners of that type of medicine.
Science has supplanted art as the core, the heart, of medical practice. All things medical in this day and age must be "evidence based." The human being is viewed more in the light of a malfunctioning automobile engine that can be disassembled, reassembled, and fine-tuned many, many times, with the holy grail number being infinity, and with cost being immaterial.
Why anyone thinks they want to live much beyond the age of 75 or 85 is a mystery to me. Your skin is thin, with the tensile strength of wet Kleenex. Your hearing is, huh? Your vision is best described as "your lyin' eyes." Your contemporaries, you know, the ones who don't give you a blank stare when you say things like Jack Benny, Bob Hope, Bing or Frank (no last names needed) are dying, in the funeral parlor or already underground.
Today medicine is in danger of becoming, not about making every life a good life worth living without regard to its length, but about making a good living off of every life for as long that life can be tested extended and milked. Repeat as needed, if not more often.
We had a name for practitioners of that type of medicine.
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I, for one, hope to live a long life, partly so I can keep reading fine writing such as yours. Even if it has to be in large-print editions.
This account highlights the inconsistency in Medicare's application of criteria for reimbursement. To date, Medicare refuses to cover the cost of genetic testing for BRCA mutations in women who do not have an established diagnosis of cancer ("signs and symptoms of disease") despite the overwhelming medical evidence that effective measures can be taken to significantly reduce the risk of cancer where mutation status is known.
Apparently a multi-million dollar company can influence Medicare reimbursement policies more effectively than the individual women whose lives could be saved through information from genetic tests which they may not be able to afford.
Apparently a multi-million dollar company can influence Medicare reimbursement policies more effectively than the individual women whose lives could be saved through information from genetic tests which they may not be able to afford.
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Too bad FDA shut down the health risk calculator window of 23andMe, an upstanding company that provided an inexpensive and helpful service that sparked countless quiet conversations between patients and their doctors, and when confirmed by diagnostic level tests, led to helpful, effective treatments. Better health and lower costs of care is apparently not the issue.
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You are so right! There are many, many companies that are doing right by and for patients. Singling out bad actors generates more news but the real progress against disease and health care costs will be the result of turning the medical system into a wellness system through personalized medicine!
Maybe the FBI needs to investigate the co-incidence of 2 bankruptcies apparently defrauding Medicare of millions. Why aren't Dr. Kasirajan, and Dr. Jolly going to prison? Sounds like Ally Clinical is a fraud as well. Collusion of Gov. Bobby Jindal as well being brought into question. Didn't he just announce a run for president?
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The article did not adequately explain how these genetic tests improve a patient's response to a drug. I've heard of genetic testing to determine if a patient is at-risk for a particular disease (e.g. breast cancer) but how do these tests guide existing treatments? I wish the article had offered an explanation about how this is done. I'm also not sure why companies like Renaissance are allowed to pay doctors to enroll patients for studies. Shouldn't the NIH and the Dept. of Health and Human Services be involved in regulating studies like this and have complete oversight? It stands to reason that participation should be strictly voluntary since it's an obvious set-up for abuse like this. Lastly, there are the doctors themselves. Dr. Jolly and his ilk who know exactly what their company is doing and participate in corrupt practices anyway have no fear of losing their medical licenses. None. In order for a doctor to lose their license their conduct must involve such gross negligence (repeated, long-standing negligence with frequent documented instances involving endangerment to patients and repeated warnings) that nobody, no state, no governing body will strip any doctor of their license for something like corrupt billing practices. Doctors know this and behave accordingly. Perhaps that needs to change too.
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the author of the article presumed that it was writing to an audience already familiar with pharmacogenetic testing and the thrust of the article was not so much on it but the fraudulent business practice that revolved around it. agree that the editor could have linked an article from carl zimmer or gina kolota from the science section to expound further.
Pharmacogenetic testing provides information about a patient's likelihood to have an adverse response and/or a therapeutic response to a medication, which can inform the physician whether to avoid prescribing a certain drug or tailoring the dose (increased or reduced) according to his or her genetic variant status. This is the foundation of personalized medicine.
Pharmacogenetic testing provides information about a patient's likelihood to have an adverse response and/or a therapeutic response to a medication, which can inform the physician whether to avoid prescribing a certain drug or tailoring the dose (increased or reduced) according to his or her genetic variant status. This is the foundation of personalized medicine.
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Big dilemma for the US: do you continue the rigid ideology that govmnt is bad, and starve the beast to beat it back: If you do, the fraud will skyrocket. Or, do you support govmnt to make it smarter and more efficient to create better rules, regulation and oversight to keep industry honest and spend our tax dollars most efficiently and effectively?
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What's so surprising about this? There's MONEY to be made! We live in a laissez-faire capitalist society. Hey, it's Amerika. And it's been that way since day 1. Money wins out over the public good every time. Classism lives! (and racism, too)
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medicine in many non-free market systems (i.e., North Korea and former Soviet Union) left a lot to be desired despite the absence of "free enterprise". Apparantly that one variable is not enough to determine whether a medical system produces "good" or "bad" results.
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What a cheap shot! A single-payer system doesn't mean we're doing to become like North Korea or Russia. Some of us who strongly support a single-payer healthcare system are also strong supporters of our capitalist system, as long as it is fairly regulated, and thieves go to jail.
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This is a gold rush. You remember what's that like, don't you? Everybody wants a piece of the action, no matter if they can deliver on their promises.
If we can keep the loss due to outright fraud to under 10% then I'd consider that a victory.
If 50% of the fraudsters eventually serve at least one year in jail, I'd call that a triumph.
I'll settle for an even score. Reality doesn't promise much.
If we can keep the loss due to outright fraud to under 10% then I'd consider that a victory.
If 50% of the fraudsters eventually serve at least one year in jail, I'd call that a triumph.
I'll settle for an even score. Reality doesn't promise much.
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Unless and until we remove the profit motive in health care, we will continue to be beset with fraud and sub-standard care. How is it we allow corporations to make a great deal of money off our populations health care needs is beyond me. How we can rank so low compared to other countries health care systems, considering out economy, is scandalous.
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This is the tip of the iceberg. The pharmaceutical industry has been compared to the tobacco industry in its corrupt pursuit of profits at the expense of the health and even the lives of its customers. Too many physicians have been co-opted by this sleazy industry.
Why are we so willing to accept the role of profit-making businesses in health care? Would we allow big businesses to take over our churches, mosques, and synagogues?
Why are we so willing to accept the role of profit-making businesses in health care? Would we allow big businesses to take over our churches, mosques, and synagogues?
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The kinds of companies described in this article drag all of us down. They impede the orderly adoption of new technologies that will improve patients lives, while apparently defrauding Medicare and other payers. And seems like the greater the potential benefit the more fraudsters show up.
Unfortunately, Medicare is unable to put a stop to these shady practices in a timely fashion. Both companies mentioned in this article got paid huge amounts, tens and tens of millions of dollars before coming under investigation. Now many of the principals have moved on to start new companies except for those rumored to have fled to avoid prosecution.
The topic here, DNA testing guided precision drug management has the potential to improve the lives of tens of millions of people suffering from an epidemic of preventable bad side effects and treatment failures. Despite the headwinds generated by the events described here, many ethical companies persevere to deliver this technology on a daily basis to help our most vulnerable patients. Based on legitimate and exciting ongoing research DNA testing will become widely used to guide drug prescribing and bring a major improvement to the practice of medicine.
Discloscure. Commenter is founder and CEO of a 15 year old pharmacogenetic testing laboratory.
Unfortunately, Medicare is unable to put a stop to these shady practices in a timely fashion. Both companies mentioned in this article got paid huge amounts, tens and tens of millions of dollars before coming under investigation. Now many of the principals have moved on to start new companies except for those rumored to have fled to avoid prosecution.
The topic here, DNA testing guided precision drug management has the potential to improve the lives of tens of millions of people suffering from an epidemic of preventable bad side effects and treatment failures. Despite the headwinds generated by the events described here, many ethical companies persevere to deliver this technology on a daily basis to help our most vulnerable patients. Based on legitimate and exciting ongoing research DNA testing will become widely used to guide drug prescribing and bring a major improvement to the practice of medicine.
Discloscure. Commenter is founder and CEO of a 15 year old pharmacogenetic testing laboratory.
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Lightfoot, given your vantage point, how do you think we can more quickly and effectively identify and shut down the fraudsters? They are going to throw a lot of noise into the datastream, at a very high cost.
Perhaps you might contribute to Paying till it hurts, a (lightly) moderated fb discussion B-)
Perhaps you might contribute to Paying till it hurts, a (lightly) moderated fb discussion B-)
Why in God's name is Medicare paying for genetic tests?
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CMS should vigorously enforce the laws and punish these individuals. Fines are not sufficient, as they will treat them as "cost of doing business." They need prison terms - and preferably long ones.
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Once upon a time I heard that love conquers all. Ha! Not here; not now. Greed conquers all.
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The NIH leadership in no small part bears responsibility for this hype. They pitched genomics to the president. They stoked this fire over decades, funneling all resources they could get their hands on into their passion. NCI director Varmus stepped down earlier this year. When will Collins take his hat?
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There are some excellent genetic testing companies but there is larger and growing number that pushes medically worthless tests. It easy since the great majority of physicians haven't a clue.
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It's not just carnies who are grifters. People in suits, with fancy degrees, can be even more convincing though with the same lack of morals.
We'll be making progress in healthcare when doctors prescribe less medication and more lifestyle changes. For certain, specific diseases such as cancer, genetic testing and tailor-made medication offer great promise. For the rest, it's just another way Wall Street makes money off the rest of us.
We'll be making progress in healthcare when doctors prescribe less medication and more lifestyle changes. For certain, specific diseases such as cancer, genetic testing and tailor-made medication offer great promise. For the rest, it's just another way Wall Street makes money off the rest of us.
Healthcare is a multi-trillion dollar industry. Everyone wants as big a piece of this as possible, one way or another. Even if only 1% of that money is misspent, honestly or otherwise, that is still a huge pile of money. More control and accountability would bring its own costs. Everyone wants the best and most healthcare and no one wants to pay for it.
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