Naked Medicine

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.

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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

Like all marketing campaigns, the aim of any pharma advertisement is to get you to think that you need a certain product or a service. I understand that all pharma companies will say that they want to educate patients on the condition first and foremost, but I guarantee that when pharma companies are forking over multimillion dollar checks to ad agencies, they’re looking for more product sales as a return on investment (ROI).

This is not a “bad” thing – this is business. Let’s say you’re an inventor and you created a program that would improve the amount of sassing teenagers give to their parents. Would you pay an agency half of your annual paycheck so that parents can be educated about the prevalence of sassing by teenagers? NO! You want parents to buy your program so you can make back at least the money you spent on the ad, plus more so you can pay your mortgage and keep your family fed!

Well, pharma’s like that. I know for some it is incredible to believe, but pharma companies are not alive in themselves, as if there is a force called “the pharma company” making decisions. Pharma companies are made up of hundreds of thousands of people who have to feed themselves and their families and put a roof over their heads. (Many of them are parents and most of them probably wish that you did invent a program that improves teen sassing of parents.)

So the key is not to spend your energy hating companies and talking trash about how misleading some commercials are or how annoying you find that a computer graphic bee is selling you asthma medication or how a group of red-towel clad women looking like they think they’re better than you want to sell you a hormone replacement drug.

As consumers, the key is to see through BS!

And the best way to see through any “BS” – whether it is from pharma or any other industry – is to know the difference between:

- what you NEED

- what you WANT

- what you are led to THINK you NEED

This last item – what you are led to think you need – is the crux of how ads work. Ads lead you think you need something, and usually tap into our animal instincts, or tap into our more “evolved” desires like convenience.

Example:

- buy this car and you’ll attract sexy partners (taps into animal instinct)

- take this pill (taps into convenience in some cases where diet, exercise, life style change is much harder)

Therefore, a question consumers can ask themselves whenever they are confronted with an agent of influence is,

“Is this what I REALLY need? Or is this what I want? Or is this what I am tempted to think I need?”

You can apply these questions to 99% of the junk ads you see on television these days, aside from pharma ads.

By Jane Chin, Ph.D.

Let’s take the trend of “personalized medicine” to start. Yes, gene-based and protein-based medicines sound alluring. We talk about targeted therapies like they’re silver bullets against deadly diseases, when we still don’t know of the long term effects of many small molecule and biologics as medicines.

All that talk about personalized medicine and how wonderful it would be if we were to have drugs tailored for us? We’ve been doing that for years!

Yet pharma has been providing a level of “personalized” medicine for years, which has created its reputation as a greedy industry with “mediocre” innovation as perceived by its critics.

Critics ask why we need yet another statin? Do we really need to have that many antidepressants in the SSRI class? How many more erectile dysfunction product ads can we endure? Should we blackbox all the glitazone drugs?

We can apply the “personalized” medicine argument to these so called “me-too” drugs reviled by academics and consumer watch dogs. We do need that many statins, because a patient may tolerate atorvastatin better than rosuvastatin. Someone’s life may be saved by paroxetine even when their depression symptoms didn’t respond well to sertraline.

But all this comes at a cost, because of the fundamental reality that personalized medicine requires segmentation of patient types to the point where what used to be ‘blockbuster marketing” is becoming “specific patient population/niche marketing”.

Truthfully, pharma marketers don’t like that. The return on investment isn’t as impressive. Investors on wall street are more impressed by blockbuster numbers than special patient populations. Executives don’t get as big of a bonus at the end of the year. Ad agencies don’t get as many multi-million dollar contracts for celebrity ads or computer graphic-generated creatures talking about allergies.

So the first shift requires pharma companies to begin training their marketers and sales teams to view patients as patient groups with specific tolerances and response profiles rather than a faceless generic group from which blockbusters are created.

This shift in marketing thinking, however, is going to take a while.

A Consumer Reports video of the Requip DTC ad (another drug used to treat RLS, manufactured by GlaxoSmithKline) has been published.

Let me first state that I’ve seen the Requip ad in question many times when I watch TV, and each time I have the same negative reaction to the ad. This means I have some negative personal bias against the ad itself and the way the company is marketing this to consumers en masse. That said, I decided not to go to the drug company’s “defense video”, which may predispose me to additional bias, and I present my analysis of the anti-ad video by Consumer Reports.

A young woman is seen in the ad to go through the drug company’s ads line by line. She comments on the statements made by the drug company ad. She doesn’t really “analyze” the statements as much as comment – and there’s a big difference between an unbiased analysis and editorial/opinion/commentary (example, “Ooh! Sounds Serious” and “Sounds like the side effects are worse than the condition!” and lots of sentences beginning with exclamations like “Ahh!”).

Given that she doesn’t suffer from RLS, her commentary is biased and nothing more than an opinion. I’d like to hear from a member of that 3% population who DOES suffer from RLS and hear whether he or she agrees that the side effects are worse than the condition.

She does mention selectively the 2 people whose compulsive gambling caused them to lose over $100K each as a result of the side effect of Requip. $100K is a lot of money, no question about it. But 2 people – that’s a small “sample size” and in the medical community and the lines of “evidence based medicine” would constitute “case reports” – the weakest type of “evidence” and would be considered anecdotal more than actual evidence. Other types of side effects like nausea and headache probably had more reports, but $100K is more sensational. It seems like the Consumer Reports anti-ad video is using some of the techniques that they’re criticizing the drug company for doing – sensationalizing what is actually a very small percentage of occurrence.

Does the Consumer Report ad make valid points? Sure. Is the anti-ad “ad” video a spin? Yes. A gloating male voice comes at the end to say “This ad is sponsored by – NO ONE!” as a vehicle to suggest that everything it claims in the its video must be unbiased and therefore, credible. However, the video itself contains very little evidence, lots of editorial claims, and does not address symptoms of the actual condition of RLS so that consumers can be “better educated” if Consumer Reports does not believe the GSK’s Requip ad is doing a good job.

This reminds me a bit of smear campaigning that politicians use against each other. What I’d like to see is a curbing of anti-anything from activist groups. For once, I’d like to see someone spend the dollars coming up with the better solution to educating consumers credibly and objectively and setting a positive example for others to follow.

Source: John Mack who has been following the restless leg syndrome (RLS) “phenomenon”.

The FDA has just approved changes to product labeling for popular “lifestyle” drugs Viagra, Cialis, and Levitra. These drugs are meant to treat erectile dysfunction or ED, and my calling them “lifestyle” drugs will trigger the ire of pharma companies, but let’s face it, these types of drugs don’t become blockbuster for no reason.

If you didn’t know, Viagra was born of research on a compound originally intended to treat heart disease. Who knew that the interesting side effect of the compound would create such a media sensation? (not to mention all the lame jokes and commercials accompanying these medications)

The FDA began investigating the potential link between Viagra and similar drugs with hearing loss after reading a case report published in April 2007 in the Journal of Laryngology & Otology. The agency found 29 post-marketing reports of sudden hearing loss in one ear for patients taking Viagra and similar compounds. Now, the FDA wants the drug makers to warn consumers taking ED drugs about the risk of sudden hearing loss after “a very small number of patients” reported sudden hearing loss, sometimes with ringing in the ears and dizziness. Patients who experience sudden hearing loss are advised to stop taking the drug immediately and get medical help.

Given the number of prescriptions that have been dispensed for Viagra and family, 29 reports of sudden hearing loss really isn’t a “big” number. However, let’s take this in the context of the current media attention on children’s cough medication calling to be banned because of less than 60 total deaths over the span of more than 35 years (1969-2006). Even if infant deaths due to cough mixture were attributed to inappropriate dosing, 29 drug-related adverse events of anything these days may be too many to be ignored.