Category Archives: Truth in Medicine

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 I Chose NOT to be a Doctor

I was once a premed.

I chose not to become a doctor because I wasn’t truly interested in the profession, it was something I felt I “had” to do or “should” do because I happened to major in biology. And being a first generation Asian-American there was also pressure from being a “Tiger Cub”: we have limited career options: doctor, lawyer, engineer. I suck in math and was good in biology. Guess which option I had?

In my undergrad classes I was among other premeds; many of them went in for the Money, the Prestige, for their Parents. But they will all talk about how much they love helping people/patients on their applications.

I did consider taking the MCAT and even paid for one of those “prep courses”, in case I changed my mind. But I knew my grades weren’t good enough, I didn’t have “connections”, and I wasn’t going to throw good money after a bad risk, especially when that money was already borrowed money via student loans. I went to grad school instead.

Then I started working in the healthcare industry, first working for the pharma industry. Maybe the nature of my work in pharma predisposed me to witness the doctor-industry relationship in a way that brought out some of the unsavory traits of the medical profession.

I saw some of these doctors up close – their lives (and lack thereof), their values (and lack thereof), their character (and lack thereof), bedside manners (and lack thereof).

We are constantly reading about how “evil” the Pharmaceutical Industry is and how they corrupt doctors and so forth – that gets a lot of coverage in the presses. Well, I’ve seen it from the other side: there are doctors who have become savvier businessmen than they are savvy clinicians and they are perfectly capable of manipulating drug companies to fulfill their personal interests. I’ve had doctors asking me for favors that I knew had nothing to do with improving patient care. I’m not embarrassed to admit that my first year of working in industry had almost completely destroyed the trust I used to have in doctors.

I saw the state of Managed Care and the “healthcare business” that has made doctors more busy with administrative work than taking care of patients. A HMO doctor once explained to me that he goes through each day making sure he breaks even by seeing 50 patients. He knows how much $ he gets paid per patient from the HMO. So he has to see a certain # of patients to stay in business. Depending on the patient’s condition, say the patient has a cold, he’d spend a few seconds with the person, and knowing that the patient would expect “something” for the visit, the doctor would write a prescription for an antibiotic just to get that patient out of the office, so he could see the next patient.

The medical profession was not something I’d ever wanted for myself if I did not have a deep-rooted passion and conviction about going into the profession. In fact, the medical profession is one that I would not encourage my child to go into, unless again, he expresses a serious conviction about becoming a physician. I actually have to be careful about my own prejudices – that I do not vehemently discourage my child from considering this profession. That would be as bad as the Tiger Mothers who force their children into the medical profession.

I know this puts me in the “outlier” group of Asian mothers. But then again I’ve always been an outlier.

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.

Pharmacy and McDonald’s: Strange Bedfellows that Aren’t so Strange

My friend Natalie Bourre saw my post about the non-biodegradable Happy Meal photo-essay and told me about a Canadian Pharmacy that had, as part of its weekly promotion, a coupon for McDonald’s.

This promotion is no longer on the corporate website, so you will have to visit Nat’s blog to see the screenshot she captured when those coupons were prominently displayed at the “CLICK ME NOW!”-eye-level.

Here’s what we DO have for this week’s promotion, however. A special offer for seniors who spend $50 or more with the drug store:

And here’s why I think it’s not so strange that a pharmacy should accept advertising from McDonald’s, and why an establishment advocating for better consumer health would not be a strange bedfellow with a fast food company:

If we are all more responsible with our health and become epitomes of good prevention and healthy lifestyle choices, pharmacies would go out of business. Or at least struggle a bit in the pharmacy business.

Don’t get me wrong, we’ll always need drugs and stuff that pharmacies dispense, by the mere reality that we are mortal and therefore subject to the systematic and gradual deterioration called “aging”. But people who don’t have serious health issues requiring chronic medication and healthcare intervention aren’t going to be frequenting drug stores. Healthy people who don’t need medication are not that great for the long term robustness of a drug dispensing business.

Let’s also not forget that when we’re at the drug store waiting for our prescription filled, we also get to wander around the aisles for some impulse purchase, as well as doing some shopping for toothpaste or shampoo or laundry detergent or Halloween costumes (drug stores these days are almost like departmental stores, offering things you’d normally not associate with drug stores)! It’s not just the drugs dispensed, but all the opportunistic non-medical drug store purchases that contribute to the bottom line.

The way I see it, promoting McDonald’s now may help create new customers for tomorrow.

Acai Miracle Berries is Mostly Miracle Marketing

In experiments conducted by the US Dept of Agriculture, volunteers were asked to ingest large quantities of fruits that have been identified as having high levels of antioxidants, and their blood were subsequently tested for antioxidant capacity. One important note is the large amount of fruit required per ingestion – for example – volunteers in the Kiwi fruit group must eat 4 kiwis. The cherry group? 45 cherries. This should give consumers an idea of the potential “starting” dose needed to gain an antioxidant benefit – and this is PER DOSE. (imagine eating 45 * 3 cherries a day – if you want to get the benefit of cherries’ antioxidant properties with every meal.)

This does make for an attractive commercial market to give consumers “concentrated” forms of antioxidants – except most of companies providing these types of nutrition products are not regulated by the FDA – that branch of the government regulating food and drugs to make sure that you as a consumer aren’t being ripped off or worse – physically harmed by ingesting unsafe products. Unfortunately, history has shown that the FDA only steps in when enough people get sick or if a few people begin to die from the so-called “nutraceutical” – just look at the ephedrine cases in the multi-billion dollar weight-loss industry.

Currently there is no agreed projection of antioxidant intake because this can fluctuate based on individual energy intake, caloric consumption, and especially environmental or confounding health related factors like exposure to cigarette smoke or disease (increasing body’s oxidation burden). There are researchers who are trying to determine what these individual needs may be, but for the most part, consumers have been inundated by commercial entities eager to profit on a perceived benefit of “high antioxidant intake”. For example, via Quackwatch:
http://www.quackwatch.com/01QuackeryRelatedTopics/PhonyAds/acai.html

The verdict? If you like to drink exotic berries for the taste, there’s no problem with indulging yourself but if you’re looking for some of these commercial products for bona fide healthcare benefits, require the claims to be backed up by randomized, double-blind placebo controlled clinical trials, with full disclosure of side effect profiles experienced by the human subjects.

(…and if there is really some miracle plant bearing amazing therapeutic properties, the pharma companies would outrun anyone to isolate the agents, synthesize/mass produce, and submit it through the proper legal govt channels for commercialization! that was how we got cancer drugs from the pacific yew tree.)