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Category: Affordable Healthcare

The Theranos Problem in One WSJ Graphic

Now that Theranos is allegedly/denying-trying to raise money, speculations continue as to whether it could survive the Wall Street Journal article, Hot Startup Theranos Has Struggled With Its Blood-Test Technology, or whether a big industry player may swoop down to acquire the company.

In terms of “who would be audacious (to use a polite word) enough to possibly merge/acquire Theranos”, I think a diagnostic company would be more a likely candidate… you know, one of the big players that Theranos was meant to “disrupt” the business of.

The short sighted assumption from many people thus far, is that Theranos was the only company that had the “foresight” to reduce sample volume required for blood based assays.

Can we actually believe that NONE of the big players NEVER considered the competitive advantage of reducing sample volume required from patients and human subjects? Are we saying that all these years no one had ever realized how many people hated needles, and the kind market leadership position one may gain if one creates an assay method that enables accurate sampling of mere drops of blood versus vials of blood?

When we look at Theranos’s “accuracy” compared with hospital results, most scientists familiar with the assay process can deduce the magnitude of what needs disrupting:

The best performance in the graphic from Theranos in terms of “accuracy” compared with a hospital result “standard”, is the glucose test.

This is nothing to be impressed about: getting the glucose reading right is no newer than the finger prick glucose draw available from today’s diabetes management devices. It only shows Theranos got their tech as right as what is already available in terms of a finger prick blood sugar test.

Perhaps someone can use current glucose monitoring technology, modify it so it could assay for Herpes (simplex type1), and see if the same “tech” transfers readily to accurately test for Herpes. This would offer an interesting data point to show just how novel the “Edison portfolio of technology” is.

This one graphic sums up the Theranos problem: the most accurate comparison is in a variable for which cheap and accessible diagnostic is available (glucose), and not for any variables for which wide clinical use are expected (liver function tests, which are critical for a variety of medications affecting liver function).

Theranos’s results are consistently “false positive” compared with hospital standard: if a clinician believes in the Theranos result, the clinician may order the patient to stop taking medications that the patient needed and was doing well on, but should no longer be taking because the results show that liver was being negatively affected, or the clinician could switch to another less effective medication for the patient out of concern for liver function. Either case, if the Theranos test was inaccurate, this would cause harm to the patient by unnecessarily disrupting treatment regimen that was otherwise appropriate.

This is not the kind of “disruption” healthcare providers want.

From a business perspective, Theranos’s FDA approved use for its product has a very narrow indication (Herpes), yet the test is commercially available without authorization from a licensed healthcare practitioner. This is great for the company’s bottom line, because the (federal) agency will have a tough time identifying which kits have been purchased for “approved” use and which kits are actually used “off-label”. The pricing advantage allows Theranos to reduce dependence on CMS reimbursement, by going straight to consumers. Liability becomes a matter of personal injury, which may be skirted when the consumers assume entire risk by “inappropriately using” the kit.

However, this is not great from a consumer protection standpoint.

We may subscribe to a conspiracy theory about major diagnostic and device companies colluding to keep an oligopoly on expensive assay machines and profit margins for assay kits, but from a business competition standpoint, the market dominance/leadership would be too attractive for a major player to ignore in the name of market oligopoly.

Why Consumers aren’t Buying “High Cost-of-Developing Drugs” Argument

The Economist recently published an article on the government of India denying Novartis the patent for its cancer drug, Glivec (in the U.S. marketed as Gleevec).

In reading the reader comments, it is obvious that a sense of fairness violation was perceived by readers who felt that the government was correct in denying Novartis this patent, given that the readers perceived the company should have “made back its R&D losses” in developing this drug and beyond.
Image by Chris Holder
Pharma companies cite R&D development costs as well as the pitiful yield in its success rate in developing novel drugs as the reason why drugs cost so much. Thus patent is given as a way for companies to recover overall losses in this risk-intensive business as well as remain sustainable over the long term.

Yet companies are also known to go for patent extension strategies that do not represent truly novel contribution to market, by creating slightly different forms – or formulations of the drug – and then gaining patent on that slightly different form. Then companies use their sales and marketing arms to then keep patients on the “newer” (in patients’ mind, “better”?) version of the drug instead of the cheaper generic.

Those who argue for patent protection speaks about the risk and astronomical costs in bringing a drug to market. This is true, especially during human clinical trials, which consumers are rarely given the full picture of just how much “each patient” in a clinical trial actually costs the company to run the complete trial, especially when there is tremendous overhead in setting up these trials across different clinical settings within the country.

But consumers also perceive the unfairness of the pricing and when it comes to healthcare and medicine, emotions run high and it is common to conclude that pharma companies are greedy and being unfair given that they should have had already recuperated on their fixed costs and now they are using strategies to boost their bottom-line when they aren’t really investing in that drug (but they have to keep investing in their pipelines of drugs, many of which will fail, rendering huge losses to the companies).

Drug companies try, and its advocacy arm (PhRMA in the u.s.) tries, but the approach and message don’t seem effective. These messages are often very abstract and statistics-driven, which do not lend well to personalization. Statistics aren’t stories the average consumer can relate to.

Which Side Are You Really On, Jane Chin?!

I received what is probably the most passionate email from a reader of this blog that I’ve ever gotten since creating NakedMedicine.com in 2006. The email concludes with this:

I can’t figure out what your agenda is Ms Chin. Are siding with the poor hard working physicians who are fighting a losing battle with their idiot patient’s lifestyles? Are you siding with the tirelessly industrious pharmaceutical scientists who are selflessly dedicating their efforts to cure our ills? Are you siding with the poor neglected suffering individuals who are bravely pushing onward in their lives, struggling with disease, possible disease, possible pandemics, or just plain plainness requiring cosmetic medicine? Doctors, business, persons, for whom are you advocating?

I was shocked by the email, because this reader “hit the nail on the head”! He can’t figure out what my agenda is, because my agenda is in NONE of those sides he described. In other words, if I were guilty of picking “a side”, it wasn’t part of the “usual suspects”.

Here’s my very long response to my reader, to whom I’m grateful, because he took the time and effort to share with me this question that obviously is frustrating him.

******

You wrote what you felt, and I don’t fault you for that. I can sense a real feeling of frustration from you, and I don’t blame you for feeling frustrated about the healthcare system that seems to be broken in many ways.

I want to address specific points you brought up – first one being ‘cures’. I genuinely don’t think that the drug industry is prevented from, or are resistant to, discovering cures for diseases. It’s not about ‘cure’ versus ‘not the cure’ that is the problem. It is often the economy of scale that is the problem, and a very understandable one when you consider that the drug industry is – and has to run like a business – in order to remain in business. I have no doubt that the drug industry would love to find a cure – because they can charge for the price of a ‘cure’ and be justified in charging such a price.

The problem on the one hand is that many times we simply cannot find ONE underlying factor of a disease, especially the chronic diseases like diabetes and heart disease (in fact, many diabetics die of a heart attack and don’t live long enough to die of diabetes complications, especially those consuming a western diet). It is not like a bacterial infection where we can pinpoint ONE origin of the disease and target that specifically, the way we can target an infecting bacteria with an antibiotic and ‘cure’ the patient.

The other problem is about the number of people with a certain disease. For example, there may be fewer companies willing to research rare diseases that may be ‘repaired’ let alone ‘cured’, simply because the companies need to get the money somehow to do all the experiments and clinical trials necessary to jump through regulatory hurdles to even get the drug approved. When i was a graduate student, doing what are pretty simple experiments (and not even in people – i worked off the petri dishes), i was often using reagents that cost my employer thousands of dollars to purchase from reagent companies. Each of my experiments has to cost at least a thousand bucks, and many of my experiments failed and produced no result.

These prices are nothing compared to the amount of money it costs to run a clinical trial at the scale required by the FDA. Now the drug companies have to pay for the drugs, the cost of mountains of paperwork needed to get the clinical trials started, the doctors who do the clinical trials (and some doctors get really snobby and brag to each other about how much $ they can muscle out of drug companies “per patient” to enroll in the drug companies’ trials), not to mention the “overhead” that the academic institutions charge the drug companies because their doctors work there (and these overhead costs can mean more than 50% of the total study budget).

And then most of the drugs end up not passing the FDA’s requirements and fail to get approved. So if you’re running a company, you will tend to want to go into areas where you will likely have more customers – heart disease for example – just so you stand a better chance of keeping your company operating should it succeed in getting a drug treating that disease approved. This is also why the government has to create incentives for companies that are willing to go into rare or “orphan” diseases – for example, Gaucher’s disease is a rare lysosomal storage disease affecting maybe 1 in 40,000 people. A drug company that competes in this market will be happy selling 1 prescription every 3 months.

I honestly do not view drug companies as entities that profit from the suffering of others, because of the logic of this assumption: If drug companies are creating diseases in people in order to make drugs for the very diseases they created, then that to me qualifies for the statement. However, drug companies happen to offer the tools to treat the disease, not unlike device companies making scalpels and surgical tools to allow doctors to cut us open should our illnesses demand it. It seems illogical to me to accuse device companies for profiting from people having tumors that require scalpels to operate and excise the tumors – unless we’re also implying that the scalpel companies are putting tumors in people that only their brand of scalpel can remove.

Additionally, I have observed that for the most part, people in our society today tend to prefer that we “have a pill to treat XYZ”, so that they do not have to do the hard work required to get their own health back on track. And then you add to the fire media agencies that charge pharma companies millions of dollars to come up with brainless gimmicky advertisements, and it is no wonder why many people feel like the drug companies are “profiteers of suffering.” Some years ago, there was a government funded study that shows that rigorous diet and exercise will help reduce diabetes risk at a very real level – in fact – the study patients who had diet and exercise regimen did as well in reducing their diabetes symptoms as study patients who took an anti-diabetic drug.

But why hasn’t the government or the doctors (not the drug companies – their responsibility is in making drugs) done anything about this amazing result? Because the of costs involved to the clinics in order to make “diet and exercise” possible in patients at a therapeutic level. Clinics would need to hire case workers and nurses whose job is to counsel and support and follow each and every single patient who opts for this “natural and effective” treatment. OK then, how about asking patients themselves to do this? Seriously, if you are a patient at risk for diabetes (i.e. risk factors are there, but patient is still “pre-diabetic” and not yet requiring drugs to control their blood sugars), you have everything you need at your disposal to go for the natural and effective (and less expensive than prescription drugs) cure! why aren’t patients doing this? because willpower and discipline are key – and you’re going to need both for a lifetime to prolong the onset of disease.

I can share this true experience – my husband had prediabetic blood work results some years ago when I urged him to see an endocrinologist, because his side of the family also suffers from diabetes. the endocrinologist told him that because he was so young (not yet 40 at the time), she preferred that he try the old fashioned diet and exercise, and see if he could get the risk factors down, before she put him on a drug. He happens to have a level of willpower and discipline that even I don’t have – and he altered his lifestyle dramatically – and it was enormously difficult. 6 weeks later he went back and the endocrinologist was so impressed with his results that she told him that most of his blood work results were approaching normal numbers. But she also told us that not every patient she sees can make this happen – and often she is forced to give the patient drugs to make sure that the patient doesn’t end up with uncontrolled diabetes symptoms (resulting in all sorts of nasty things including death).

I see drugs as exactly what you said you wished to see – repairs and cures. However, the reality is, few are truly cures because of the complexities of most diseases, and repairs don’t always “fix” things without creating new problems (called side effects) EXACTLY because of the complexities of most diseases.

The doctors’ hands are tied not by pharma companies, but by insurance companies as well as their own malpractice lawsuit concerns. Your average primary care doctor has to track how many patients he sees everyday because he needs to make sure he breaks even. That’s not the drug companies doing, but the insurance companies that capitate how much doctors are paid for doing what. So you also have a system that don’t reward doctors for spending more time with patients – in fact – you’re making it very bad business for the doctor to spend too much time because then he’ll lose money that day – and this does not do well to cultivate trust with patients who then need to heed the doctors’ advice about doing the hard things they need to do to steer their health status back on track.

I hope my email begins to help you understand where I am coming from – perhaps I can’t take any sides because I don’t think there are any sides that I can reasonably take without acknowledging that there are other entities that also need to be held accountable. the healthcare ‘system” is truly a “system” and a staggering, complex one at that. the best I can do is to help the consumers – people like you and me – to think for ourselves about what is being “sold” to us whether it’s from the drug companies, insurance companies, the government, the doctors, even patient groups. If I am guilty of siding with anything, it will be on the side of “critical thinking” about the system of healthcare with all of its players.

Best wishes,
Jane Chin

Will Healthcare Become a Moral Question? (Are we already there?)

By Jane Chin This morning I was skyping with one of my favorite people, Bhupesh of Ethnicomm, when we began talking about the current state of healthcare. Bhupesh lives in Canada, where healthcare is socialized in a way that has become apparently very attractive to various healthcare “activists” and interest groups here in the U.S.

Right now many people here in the U.S. are tremendously upset with insurance companies because of the way these companies make financially based decisions about people’s lives. The stereotype, for example, is the image of a middle-aged MBA-educated executive sitting in front of a spreadsheet that gets him to conclude that letting a chronically ill patient die may be cheaper than approving for reimbursement certain “non-standard” medical procedures or organ transplants or experimental use of an approved drug.

The government is a bloated bureaucratic pseudo-organization that struggles with its constituent interests but is really focused on its primary priority: keeping itself (the government) alive. Letting the government run healthcare, in my personal opinion, is not going to get us better care than the situation we’re getting from insurance companies.

If healthcare is a question about access best served by the government, close your eyes and flash past to the last time you were at the DMV (department of motor vehicles). How was that experience for you? I assumed you were relatively healthy when you last visited the DMV. Now imagine yourself in a sick condition and trying to deal with the inefficiency and the staff. When I was in graduate school there was a time when I was sick and had to sort out a problem at the DMV. I spent about an hour of the three hours I had to wait there retching in the bathroom. At least the bathroom was clean.

Here in California our state government had done such a great job that the state is hemorrhaging money. In fact, the DMV here has to stop working on Fridays just so the government can stop bleeding as much money as it’s been bleeding. I don’t dare to imagine what a California-run healthcare system is going to look like, but I can guess that the other half of our hospitals that somehow managed to remain open may probably start closing as well.

Then Bhupesh and I wondered about a Darwinian question, to give the benefit of the doubt to a government that may ultimately decide that, for example, once you’re over 65 years old, you should not be eligible for big expensive procedures (like organ transplants) because you’d be cheaper to the government DEAD. If you think that it’s bad for insurance companies dealing with a few million lives to start seeing you as a statistic, wait until you become one in the hundreds of millions of lives to a government-run healthcare system.

Maybe we really should let nature take its course rather than stuffing ourselves with pills and new organs and medical devices to stay alive. Why not die our “natural age” rather than fight to live an unnaturally long life?

I remembered thinking about a similar question recently, when I thought about babies who were born so premature that they were called “micropreemies“. These are babies born before 26 weeks of gestation (normal is at least 37 weeks) and under 3 pounds. A premature baby or a “preemie” is born before 37 weeks. Put Darwin’s survival of the fittest test, and it’s safe to say that most of the preemies and all of the micropreemies won’t make it.

But this is the beauty and the beast in living in today’s technologically advanced society. Babies who might otherwise not survive can survive and thrive when born in this day and age. So too, can the same reasoning be drawn to we adults who might otherwise want to keep living past a heart attack or cancer. We live with these options to fight and win over the diseases that 50 years ago may swiftly kill us. The trade off is that we sometimes end up living a longer, more painful existence until our untimely death. (I’m not going to get into a soapbox about the ethics of having octuplets when you already have 6 kids and are still living with your parents)

The healthcare question when taken into this context, then becomes more of a moral question and conditioned by social and cultural “norms”. How old is too old? How sick is too sick? How much money is too much money to pay to keep a human being alive? It’s one thing to answer these questions as an individual or a member of a family (then we’d naturally say, “life is priceless! at any cost!”), but it is another to try answering these questions as an individual making policies and decisions for hundreds of millions of lives. Then there IS indeed a price for a human life, because there is only a certain amount of money that the government has to use for healthcare of all its people.

Governments are good at justifying collateral damage or “sacrifice a few to save many more”. How do you feel about being a member of “the few” instead of a part of “the many more”?

Retail Clinics: Quick When You’re Sick

By Dan Abshear

Recently in the media, issues have been addressed regarding the specialty of primary care or family practice doctors and the shortage of them in the U.S. In summary, reasons for the shortage that exists are due to the specialty not being that profitable for a doctor compared with other specialties. As a consequence, the doctors view the specialty as not a desirable choice apparently quite often, although the specialty is greatly needed in the health care system and for the public health.

As a layperson, I view primary care as ultimately a specialist in nothing in particular, yet knowledgeable in a large variety of medical areas, which I believe, makes them very valuable to those patients seeking restoration of their health. Furthermore, there is a comfort level with those in this specialty compared with other specialties, one could speculate. So the shortage of primary care doctors is in fact disappointing. Perhaps most disappointing is the atrophy of the doctor-patient relationship unique with such doctors.

Yet one possible solution is what is known as retail care clinics, and their popularity was increasing not long ago for a variety of reasons.

First, I’ll offer a definition of a retail clinic: A retail clinic is usually located in a convenient location, such as a shopping area, and are smaller than most doctors’ offices in regards to geographical space. Usually, these clinics are staffed with a nurse practitioner that often have the ability and authority to provide the same quality care as a primary care physician, and do so with the same standards regarding accountability and autonomy. If you happen t o go to one for what may be considered a mild ailment, for example, for such conditions as allergies or the flu, you will notice a unique and pleasant paradigm towards your care at such a clinic:

They are quick. You are normally in and out of there within a half hour or so. This includes a thorough assessment and treatment regimen offered. Unlike typical doctor offices, these clinics are walk-in clinics, so there is no over-booking of patients.

You actually dialogue with your health care provider more so than you have experienced in a traditional doctor’s office due to other doctor offices often being incredibly busy from seeing too many patients during a typical day, as this is coerced and dictated by the health care system that employs these primary care doctors you may have seen in the past, which is typically the case.

The cost of going to such a retail clinic, which is sometimes termed an ‘urgent care light’ clinic, is usually about ¾ the cost of a typical primary care doctor visit.

You will likely notice no decline in the quality of care that you receive. In fact, likely you will experience greater quality on many different levels, both on a personal and clinical level.

Critics of such clinics include the American Medical Association and various medical societies, yet in my opinion, they are simply vexed because of the invasion of these clinics on their turf.

If it is discovered that you need greater medical care or attention than the retail clinic can provide for you during your visit at their urgent care light clinic, you will be referred to a location that can provide the care you are determined to need by the clinic’s heath care provider, who has likely relationships with the hospitals and others in the medical community for which they serve.

So most patients of these retail clinics are pleased with the care they receive from them, which is why they continue to grow in number under different names, as they have become franchises, yet the concept is new, so only time will tell regarding their popularity with various communities.

The clinics provide a response to the shortage of primary care doctors, and possibly are an answer to other problems that exist in the health care system in the U.S. The clinics are more authentic, and are therefore more beneficial for public health in many different ways.

“Follow where reason leads.” — Zeno of Citium

Disclosure: Author Mr. Shear was formerly an employee of the pharmaceutical industry (sales) and is currently seeking employment in the same industry.

Not Poor Enough or Not Sick Enough

Shirley Loewe had one of the most aggressive form of breast cancer (inflammatory breast cancer). Her tumor was already 4 inches wide when she was diagnosed in 2003.

Adding insult to cancer, Shirley was repeatedly denied care because she was either “not poor enough” to qualify on Medicaid in Texas because she made $15,000 a year, or “not sick enough” to receive treatment otherwise.

Texas had an obscure law that allowed women diagnosed in federally-funded cancer detection clinics to cover women with cancer by Medicaid even if they did not otherwise meet eligibility – only Shirley did not go to a federally-funded cancer detection clinic because she had no clue about this obscure law.

Since then, Texas amended the law to lift this restriction, but it was too late for Shirley – she died in June 2007.

Source: A Breast Cancer Death, Tangled in Bureaucracy.

Backgrounder on Diabetes Drug Avandia Controversy

I’ve been tracking the various developments and commentaries on the controversy surrounding diabetes drug Avandia (rosiglitazone, manufactured by GlaxoSmithKline). For those of you interested in background information and commentaries relating to the use of Avandia and increased risk for heart disease, as well as the affordability of chronic medications like diabetes drugs, I’ve compiled a short reading list including abstracts to the original research articles to help you get started. Please read my conflict of interest disclosure at the end of this article. (more…)

Massachusetts Mandatory Health Insurance Law for Young People

I don’t know what your finances looked like when you were when you were 18 or in your early twenties, but I was a starving graduate student barely able to afford rent. If now I have to pay at least $100 each month on top of my expenses, I’d sink deeper into debt unless I move out of that state. Now, MA is requiring all taxpayers to prove that they have health insurance, which would include young adults who are still either in school or starting to chip away at student loans with their first jobs.

Of course, the politicians are going to espouse the wonders of early prevention and encouraging young people to take better care of their health so that they could lead long, healthy lives. One of the reason why HMOs love healthy adults and young people is because the number crunchers have found that they are less likely to use health care simply because statistics show that this population is healthier than an older age group. This means the HMOs will come out ahead in their business of covering for treatment and cost of care. The truth is, the Massachusetts bureaucrats want the young to pay and subsidize health care utilization by the aging population. We’ve seen how well this concept of “taxing one generation to pay for the other generation” has worked for social security; health care is a hegemonic burden that is finding its expenses to all segments of the population (except for illegal immigrants, but that’s another unwieldy topic).

I’m glad I’m not a young person living in Massachusetts.

Medical Malpractice Makes Unaffordable Healthcare

Philip K. Howard is a lawyer, author, and chair of an organization that aims to “restore common sense to American Law” called Common Good. In a recent issue of Wall Street Journal, Mr. Howard suggested that our aims for safer and affordable American healthcare can only come true when we change our current legal system. This legal system has become bloated with administrative costs and malpractice concerns that burden the overall healthcare system. (WSJ original article…)

Truth in Healthcare Sits Between Extremes

A friend sent me an article called, “Drugged out of our minds“, written by Larry M. Jones, a retired Navy Commander and aviator in Texas. Mr. Jones thought the reasons given by drug companies for high drug costs smelled fishy and didn’t appreciate having to fight for a parking space or waiting room seat with pharmaceutical “reps waiting to peddle their wares to the physicians.” Mr. Jones said it was a shame that some American citizens had to skip or split pills because they could not afford their treatment.

I can’t argue with how this “stinks” and how nice it would be if we could get free or affordable medications. I have a chronic condition for which I need to take daily course of prescription strength medication and I have to consider the cost in my budget. I may also have some sympathy toward the pharmaceutical industry because I have worked in pharma companies for most of my professional life and I have some insight into how much research, development, and marketing costs.

Healthcare and medicine strike highly emotional cords in all of us. We – not just the seniors – are becoming victims of “poorly managed healthcare”. Working professionals are fighting a different battle in healthcare – employer healthcare coverage – than elderly or retired citizens, but we all eventually progress to the same question of affordability and healthcare cost. (more…)

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