America the Swindled - How Big PhrMa Games Us All

As is generally well known, Americans pay the highest prescription drug prices in the world. Drugs to treat diabetes cost 3-5 times more than just about anyplace else, including Europe, ditto for statins (such as Lipitor) and cancer drugs. According to one Big PhrMa honcho, we Americans have to pick up the slack in drug costs given how the rest of the world remains firmly subsidized by their own governments. Translation: their governments actually care enough about them to control drug costs and not let the people get scalped and swindled.

But why should this state of affairs exist? The reason, we are told, is that it costs mucho money to bring decent drugs to the marketplace, the costs of research and all. Hence, unless these costs are borne by someone, some group the research won't get done and the drugs won't manifest - so millions will then have to do without, including the ones getting 'freebies' off us Yanks.

Is this really true, or is it mostly horse manure and PR?

Consider just eleven of the 12 new cancer drugs approved in 2012 which were priced above $100,000 annually. Further, a 20-30 percent copayment can make them unaffordable even to well-insured patients (i.e. those with at least 'Cadillac' health care plans).

But why these outrageous costs? On the one hand the companies claim the high prices reflect high research costs, but on the other hand they insist the high prices reflect the precious "added benefits" of controlling and curing cancer. In other words, the costs aren't really based on current expenses for research but rather future projections of effectiveness such that future health costs don't come to pass. In other words, the current costs of these drugs are really predicated on imagined savings once cancer is cured or controlled.

Is it just me or does this not sound an awful lot like the Neoliberal ploy  (in the “Postal Pension Reform Act of 2006”) requiring prepayment of pensions for 75 years by the U.S. Post Office - which effectively incepted its bankruptcy?  Of course, in this instance we have the future projections of Post Office obligations engendering  monstrous debt - suggesting a need for privatization - which Neoliberals get boners about. But when you think about it carefully the future "benefits" toted up to costs by Big PhrMA also translate to debt - either by the gov't or by the people who have no choice except to purchase these drugs (unless they prefer to die).

A recent piece in the AARP Bulletin (May, , p. 22) provides further insight into the PhrMA gaming on this. Or should we call it Neoliberal faux market gamesmanship?:

"The argument that companies are offering improved drugs for these higher prices is not true. Oncologists find that most new cancer drugs provide few clinical advantages over existing ones. Only one of 12 new cancer drugs approved in 2012 helps patients survive more than a few months longer."

In other words, it's all about milking massive extra profits out of "new" drugs that provide little added benefit. The drug companies, we can conclude, are only in it for profits - and could care less about substantive new research that truly advances cancer treatments.

The AARP piece goes on to puncture more BS:

"The industry argument that high prices reflect huge research and development costs also doesn't hold up - at least given the few facts companies make public .  Indeed, the actual dollars that companies have put into research from 1995 to 2010 have generated six times more revenue than the costs of the research - a sign that they are charging too much for little patient benefit."

Again, we're being led by the proverbial nose to believe a pile of codswallop. And now, if these companies are lying through their teeth on the benefits of the cancer drugs, what about statins and other high priced drugs? It makes sense their benefits are oversold as well (especially given the fact that nearly as many people with low cholesterol have myocardial infarctions as those with high cholesterol.) Not told you is that cholesterol isn't the real bugbear here. Its measurement in a blood test - which often indicated statins to the medical druggies - is really a sophisticated dodge. The real culprit is not cholesterol but c-reactive protein.  This substance indicated the degree of inflammation which is the actual agent triggering heart attacks. The test needed is the one for CRP not cholesterol, but then the CRP blood test is much more expensive.

The AARP article goes on to deal with these inflated costs:

"The most famous industry-sponsored estimate claims that it costs nearly $1.3 billion to develop a new drug and get it approved. This includes the cost of failures. Half that estimate, however, is not research costs at but rather a high figure for profits that companies would have made if they had invested their research money in stocks and bonds instead."

In other words, total Neoliberal perversion of the cost basis. Instead of tallying actual costs to do the research these drug company sharks are tallying up the costs of profits foregone in a whizzing stock market. (They seem to forget that stock markets can crash too.) 

In any case, it isn't a real cost to recoup from customers who faithfully pay up their hard earned money, but rather a phony cost to gouge and swindle them.   As the AARP piece points out:

"Eliminating it brings the actual research costs down from $1.3 billion to $650 million. "

Extrapolating from this, the cost of the typical drug ought to be half of what it is.  Probably less since taxpayers subsidize half of company research costs through credits and deductions granted to drug companies. The AARP author estimates these inputs bring the research costs down to $325 million.  The article adds:

"Moreover, the industry's $1.3 billion is based on a sample of the most costly fifth of new drugs, not the average for all drugs. Correcting this distortion brings company research costs down by 30 percent, to $230 million. "

The AARP goes on to point out the effect of a few expensive projects that inflate the value of the whole, hence why the median is best used instead of the average drug cost. In this case the company cost of research projects dives to $170 million.

The article also exposes more cost pricing gimmickry:

"A final way in which research costs are inflated is by backing in a large estimate for the cost of basic research to discover new drugs. In fact, no accurate estimate exists because the costs of discovery very so much, from an inexpensive lucky break to a costly 30-year search before a new drug is discovered. Removing that inflated estimate for basic research costs brings the net, median corporate research costs down to just $125 million for developing drugs."

Then we also learn (ibid.):

"Overall, basic research by pharmaceutical companies is quite small - about one sixth of overall company research costs and about 1.3 percent of revenues after deducting for taxpayer subsidies. The rest of company research costs foes to developing all those drugs with few advantages over existing ones so they can charge higher prices for them."

In another words, Americans are being swindled by sophisticated market projections, cost inflation, minor changes and other trickery. In the parlance of Neoliberals, it's what's called a "market spiral pricing strategy". It is more or less the same tactic used in inflating the costs of student loans, to increase debt there as well, despite the added costs and burdens being of marginal benefit because the benefits are so low in the existing job market. In the end it is all about enriching the Neoliberal market niche - whether drug companies or banks - at the expense of average citizens.

As the AARP article puts it:

"No other advanced country allows companies to raise prices on older drugs. No other industry raises prices on last year's cars or telephones."

It ends by advising that Congress needs to hold hearings on these spiraling drug prices especially for specialty drugs. In addition, Congress needs to eliminate the stupid rule that prohibits Medicare from negotiating discount drug prices- like the VA does. This dumbass rule entered with the Bushie Medicare Modernization Act of 2003, and was intended to be one prop (the other being Medicare Advantage) to drive Medicare into insolvency.  It should have been repealed under Obamacare, but wasn't.

With rational changes the health care cost curve can truly be bent but it will require gutting the Neoliberal imperative that encourages companies to swindle citizens to make profits. At its heart it means providing incentives for drug companies to provide truly new and effective drugs and powerful disincentives for them to produce only slightly better drugs at sky high prices.

We shouldn't remain hostage to these perverted market and pricing schemes any longer!

Vitamins Are Useless? If They Are - So are STATINS!

Comparison histogram showing how nutrients in cornmeal have declined from 60 years ago.



Once more the PhrMA -backed establishment research clowns have performed more of their bogus studies and concluded  "Case closed!" (where have we seen that before?) and that "vitamins confer no benefit and are essentially useless".  How many times have we heard this codswallop and how often have they regurgitated it in the lapdog corporate press?  Of course, we are informed - as this morning on CBS Early Show - that "this is the definitive study!"  Yeah, right.

It's no secret there is an entrenched "anti-vitamin" industry in this country, based on phony medical or statistical tests, that has been trying for decades to convince people not to "waste money on vitamins", arguing that the only result is "very expensive urine".   But what they don't tell you - never will - is the extent to which our modern veggies, crops have been diluted in nutrients!

I have a graphic above which compares the selected nutrients in cornmeal to those from 60 years earlier.  Just look at the comparisons for thiamin, riboflavin and niacin and try to tell me that you can obtain the same benefit by eating the foods containing them, instead of taking the supplements. Any such person would have to be a dupe or a moron.

Take the calcium content of broccoli. Widely grown varieties in 1950 had about 13 mg/g of calcium but today's varieties provide only about 4.4 mg/g of calcium. Similar proportionate declines have been documented in meat, eggs, and dairy products.  If you are going to be foolish enough then, to depend on foods for all the calcium you need - you are going to pay when bones are broken -say from a fall on ice.

I have been taking a calcium supplement for over 20 years now, and in that time have experienced 7 falls on ice. Not one of those times met with a broken bone - but I can't claim the same had I not taken a calcium supplement and depended only on foods, milk etc. Some skeptics might argue it's the genes, not the calcium, but my dad experienced a fall in 2005 - hip fracture- which left him frail and vulnerable afterwards.  He was never the same, with the same energy and strength afterward.

Research on nutrient decline by biochemist Bruce Ames shows the following:

- Over the last 50 years, the amounts of protein, calcium, phosphorus, iron, riboflavin, and vitamin C in conventionally grown fresh fruits and vegetables has declined by 50% or more.

- Wheat grown 100 years ago had twice as much protein as modern versions.

- Most of our agri-food crops, from lettuce, to broccoli, tomatoes, cauliflower, beans, peas, cabbage, etc. are so diluted that one would have to eat two to three times the amount daily to obtain an equal nutrient value to what one had in the 1960s. Thus, to do totally without vitamins, get set to eat four cauliflowers, three whole broccoli heads, eight oranges, five bananas (for potassium), ten tomatoes and three pounds of peas or beans!

In other words, in order to replace the nutrients, vitamins you're not getting you'd have to consume vastly larger quantities of veggies - and to absurd proportions! Who the hell is going to eat ten tomatoes, or three pounds of peas or beans in a day, or drink two gallons of milk? Give me a break! 

But this is what the anti-vitamin scolds want you to believe!   The most often cited reason for the declines is the increased use of fertilizers and genetically modified crops to boost yields to feed larger world population. The problem is this has come at the expense of the nutrient density of the crops.

Now, in the interests of being unbiased, they did get some things correct, but these are things most who take vitamins already know:

- You leave Vitamin A (e.g. in beta carotenes) alone because it's too easy to overdose on it with negative results.

- taking large surplus amounts of Vitamin E can (possibly) cause prostate cancer

- Don't fuck around with "exotics" like Ginkgo Biloba or Yohimbe root.

On the other hand, people in their elder years (over 65) need more vitamin D (in the form of D3) and they simply can't get this from foods - and they'd have to remain hours in the Sun (risking skin cancer) to get it otherwise. They also need at least 1,000 mg of Vitamin B-12 per day to avoid mental decline caused by deficiencies in this vitamin as they age. In addition, they ought to be taking a good B-complex at least four times a week, and calcium - magnesium (which is important for metabolic activity and which too few Americans get enough of.)

On the other hand, statin drugs are being pushed as some kind of a godsend or pharmaceutical elixir on millions. Why? To earn huge profits for Big PhrmA (and don't anyone hand me that crap peddled by the Neoliberal media that widespread generics will soon bring the costs down. No, the companies won't allow that to happen- even if they have to continually change one molecule to preserve a patent.)

Furthermore, according to the most robust statistical studies done, statins DON'T work! The statistics have been fudged! This  was first reported by FORBES in 2008 wherein outcomes from a control and statin-taking group were compared per capita for heart attacks. In the control (placebo) group there occurred 2 heart attacks per capita, and in the statin-takers there occurred 1 heart attack per 100. The results were then touted as "Statins reduce risk of heart attacks by 33%".

Thus:

(2 - 1)/3 x 100% = 1/3 x 100% = 33%

Which was duly reported by the hobbled corporo-media and which had many people thinking: 'Wow! I need to get statins, because hey -- if there could be 1,000 likely to get 'em and 333 didn't because of taking statins, I wanna be in that number!"

Trouble is, there was no such magnitude of success, and the actual difference per capita for the trials was kept hidden, well, at least until FORBES exposed them.

It is entirely plausible that a similar "result" was obtained for the margins of difference in prostate cancer arising from taking vitamin E, but this time - because portions of the media were on to the ginnied stats, they decided to admit that in actual fact, the results were not significant. But with "health" reporting you can be certain if nothing else that the Neoliberal profiteers are massaging the numbers.

Of course, there are tests that can bear this out! They are contingent on knowing actual sample sizes and then using the text to obtain the confidence level or level of significance.

For example, the well-known 'z-test' compares effects for two designated populations, P1 and P2, which have associated sample sizes N1 and N2. If the distinct outcomes for each population sample are then denoted by x and y, respectively, one can denote the separate populations in terms of the outcomes using:

P1 = x/N1 and P2 = y/N2

The z-statistic is then computed using:

z = (P1 - P2)/ [PQ {1/N1 - 1/N2}]^½

Where,

P = (x + y)/N1 + N2

is a pooled population and Q = (1 - P) (the variance of (P1 - P2) is the quantity in the denominator of the right -hand side in the expression for z)

Clearly, if a null hypothesis is applied such that no difference in outcomes is expected, one could have:

x/N1 = y/N2

or very close to that.

Now, here is a key element, we will know that z possesses a standard normal (e.g. Gaussian) distribution - see graph below:

if N1 and N2 are large. But, if the samples are too small, all bets are off and it is derelict to apply the z-test. For rejection of the null hypothesis (i.e. accepting a significant difference in outcomes) the obtained z-value cannot be less than 1.96 or the upper 5% of the standard normal distribution.

In effect, I'd surmise what the current anti- vitamin research is all about is not attaining this threshold for the tests they employ, which may not be the same as the z-test.

In the case of vitamins- supplements, we know that ever since Durk Pearson's outstanding research on the benefits of vitamins in the 1970s, government and Big Pharma has been out to quash the very notion of supplements as useful. Why express surprise? We are talking of the Corporate State and it protects its interests! The polluted politicians know that if Big Pharma's profits are affected - especially by a bleed off from people spending on vitamins, supplements - they will lose campaign donations from the Big Pharma lobbies for the next election cycle. Duh!

Now, since most government agencies already operate on the basis of "the fox guarding the henhouse" in terms of regulations, it makes sense that at any given time a particular agency that's been taken over by corporate power will inveigh against those interests it deems a threat...say to PhRmA's enormous profits, and hence campaign donation capacity. Thus it is that so many of the politicians seek to stamp out even medical marijuana because they know it will dent PhRma's profits - just as the medical establishment now joins the fray to try to put a lid on vitamin purchases.

We cannot, CANNOT - have the little guys enjoying so much cost-savings with vitamins to stay healthy when they could spend a LOT more on prescription drugs - if they didn't take vitamins and became unhealthy!  I mean, think of it! If they can just get these little hardheads to stop taking a Vitamin C, magnesium,  Vitamin D, or even just an aspirin each day - warning them off it - they will get their cholesterol and other numbers bad enough to warrant the prescription of costly statins! PROFITS! Wa-HOO! (And even better, if the hoi polloi get liver or kidney disease, croak and don't live long enough to get any "entitlements"!)

 Now, if anyone thinks this is "conspiracy thinking" I invite them to read the front page story in the Sunday New York Times on how the drug establishment is hyping 'attention deficit disorder' to spur sales of ADD drugs and boost profits - including for adults! (The next "challenge" according to the piece).   In much the same way, statins have now been approved for use by many more millions. Under the new advice, 33 million Americans — 44 percent of men and 22 percent of women — would meet the threshold for taking a statin. Under the current  (not yet revised) guidelines, statins are recommended for only about 15 percent of adults. You see where this is going?

Having taken over 14 vitamins and supplements for nearly 37 years I am not about to stop now, no matter what new "studies" proclaim. Also, as a person versed in statistics, I will have to see ironclad STRONG (not marginal) statistical evidence that a given outcome from use of a particular supplement is bad. Until that happens, all these specialists in negative vitamin research can go fart in the wind. It will be about that much difference to me in terms of whether they impact my thinking.

Lastly, and in my opinion trumping any inflated and bogus studies,  I was gratified when in 1998, after years of skepticism over my vitamin taking, my then physician finally admitted to me openly during a physical exam that she'd been wrong, and she now concurred with my vitamin and mineral supplement regimen. As she put it:

"Well, I did the research ....all over the place, and I have to admit now that people simply can't get all the nutrients they need from food. It's all been so diluted, that a person would need to eat massive volumes just to get the minimum RDAs of one vitamin, far less what you're taking. So keep on keeping on..."

I wish these other bought and paid for tools would also do the research, as opposed by being paid by Big PhrMA to do their brand of pseudo -research.

"Case closed?" Ha! No more than the JFK assassination case!

More Reasons to Resist the Medical Pill Pushers

In a previous blog:

http://brane-space.blogspot.com/2011/03/can-statin-drugs-really-be-this-bad.html


I noted the dangers of statin drugs in being over-prescribed (often in too high an initial dosage) as well as over-hyped. I also cited a book by Jay S. Cohen, M.D. ('Statin Drugs and Their Natural Alternatives', Square One Publishers, 2005) enumerating and describing all the downsides, including:

- Statin -triggered muscle pain , which can lead to more (anti-inflammatory) meds to correct it

- muscle breakdown (leading to kidney damage since broken down muscle proteins end up being absorbed)

- liver damage, sometimes leading to the need for a liver transplant

- Statin-related memory deficits which can sometimes be so severe they can mimic Alzheimer's symptoms ( In one case, a woman's language was so totally inchoate that when she meant to ask: 'Please pass the bread', it came out: 'Please pass that elephant'!)

- Disposition to develop polyneuropathy or peripheral nerve damage that produces numbness, tingling, pain and weakness in the limbs


All of these were documented in the referenced book, and dose-age related as observed by the author:

"Most side effects are dose-related , so preventing side effects means starting low and going slow, which is particularly important in seniors. Indeed, despite some of its questionable decisions, the FDA agrees in principle"

Further backed up by my other citations from R.D. Williams, writing in FDA Consumer Magazine (Sept.-Oct. 1997, 'Medications in Older Adults'):

"There is evidence that older adults tend to be more sensitive to drugs than younger adults, due to their generally slower metabolisms and organ functions. The old adage....'start low and go slow' applies especially to the elderly".


Sadly, too many physicians - especially primary care- are still too extensively hostages to the Big Phrma drug pushers, and accept samples as well as other perks to push these meds on patients that may not need them. The physicians themselves, often don't realize many patients (especially older) may be medication-sensitive and have severe reactions when ordered to take the prescribed dose printed on the bottle. This is often because the docs are too often abysmally ignorant, or as Cohen notes:

"Doctors are taught to trust the information they receive and to distrust information from non-mainstream sources, especially if it is anecdotal or subjective. They are concerned that under-dosing can cause ineffective treatment. Most doctors have not seen much, if any, of the low dose data. Drug companies are their main source of information."

In other words, even intelligent and knowledgeable patients may often be put on the defensive and be forced to formulate coherent and consistent arguments to ward off a given doc's med pushing. This also was reinforced in a WSJ piece ('Designing a Smarter Patient', Sept. 24-15, p. C3) wherin one fifty-plus year old nursing assistant had to fend off her doc trying to push a statin pill on her by parroting the known bogus factoid that

"by taking a statin pill you will reduce your risk of a heart attack over the next ten years by as much as 30%".

But when the suspicious patient ran the numbers and actually read the associated literature, she wasn't too impressed. In fact, what the actual stats showed was that if there was a potential risk sample pool of 300 patients (say to get a heart attack in 10 yrs.), 2 out of 3 in that sample (the two being non-statin takers) would, but the statin -taking third would probably escape. Think about that!

So, for that minute benefit, one is being asked to take a drug - often in the wrong dose for him or her- that can lead to kidney or liver damage, as well as polyneuropathy, memory loss and joint inflammation requiring more meds to correct! In addition, as Cohen observes in his book, the actual side effects are usually under-documented and underestimated by the drug manufacturers. He refers (p. 86) to the The (Physician's) Prescription Drug Reference (PDR) and points out:

"There is no routine, expeditious method for incorporating (side effects) information into package inserts or the PDR unless it is very serious or lethal. Thus, the lists in package inserts and the PDR are usually incomplete and outdated"

Thus, the potential for liver damage may often be noted in possible side effects for statins, but not that for kidney damage and patients have to go on thrice-weekly dialysis if they take too high a dose for too long. In the meantime, mostly unread doctors push these meds by parroting drug statistics disinfo, while not grasping what the numbers mean.

Of course, one of the worst culprits also in this miasma of misinformation and medical drug pushing is the PhrMa adverts that regularly pepper TV screens, brainwashing stupefied onlookers into demanding assorted drugs from their docs. (The AARP Bulletin, in piece several years ago, estimated that up to one-third of the drug companies' profits go exclusively toward advertising and if it was disallowed drug costs might go down by the same proportion)

Thus, these advertisements - which "are designed to tell a compelling tale" as opposed to documenting medical facts- have become the biggest unchecked source for flawed or spurious stats, especially on the statins. The WSJ piece just cited, for example, referred to how the nursing assistant (after her doc's efforts to get her on statins) made it a point just to scan the TV adverts for statin ads. She was flummoxed to discover that they seemed to be everywhere. Also, in none of those ads, or in the doctors' office itself, was it remotely mentioned that the more immediate risk for heart attack is not high cholesterol per se, but a high C-reactive protein value - which must be ascertained by the test for CRP (which is, of course, much more expensive than the standard blood panels for cholesterol).

Confirming the bombardment of American audiences with medical drug ads, in 2007 the UCLA Medical Center did a study of drug ads broadcast on national networks. They found that the average viewer sees over 1,000 prescription drug ads in the space of a year. As the WSJ article notes: "That's 16 hours all told, more time than the average patient spends with her primary care physician."

Is it any wonder then, as the WSJ article reports, "every $1,000 spent on advertising translates into 24 new prescriptions"

BUT, what fraction of those 24 are really needed, as opposed to being merely wanted because of being seen on the TV ad? Most estimates come to about 3-4 (based on Cohen's data, as in his appendices). In other words, nearly 83% of the prescription drugs being taken based on drug advert exposure are unnecessary. Most patients who request the drugs are merely victims of what we call the "Gruen Transfer", a well-documented phenomenon with the potential to subvert higher brain centers during an advertising exposure. (See Douglass Rushkoff's book, Coercion, which describes this form of brainwashing in detail)

This is also the basis for a critical adjoint health issue: because if a person takes one med, he or she is likely to take others in a "domino drug" effect to ward off side effects, e.g. such as inflammation. One then risks any given drug interacting with the others, or with certain foods. (For example, those taking ED drugs are warned not to take any drugs with nitrite chemicals in them.) The risk for complications from these drug interactions thus exponentiates, the more drugs are taken in concert. Since the average post 60-year old American takes no less than 9 prescriptions (according to an AARP finding in their last AARP Magazine), there is an enormous risk for adverse effects.

And up to now we haven't even mentioned the costs! Truth be told, more than three-fourths of our current medical inflation is due to rising prescription drug costs when most med-taking translates into delivering very little documented benefit for the side effects (see, e.g. Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer, by Shannon Brownlee, 2007)

In the 1980s there was an anti-drug campaign run by Nancy Reagan entitled 'Just Say No'. It is time now - long past- that Americans reinvigorate that campaign and just say NO! to the Phrma medical drug pushers and the physicians that often unknowingly abet them!