Why Are Healthcare Costs So High? Humana Says...

As a high level communication directed at a broad audience, I really like this. It effectively communicates the core drivers of healthcare costs in a no-nonsense, non-partisan, easy to comprehend (and remember) manner. And the emphasis on prevention through healthy living is fundamentally correct as well.

Nice job by Humana for shifting the blame. In reality, for the past two years, according to the Bureau of Labor Statistics, the CPI for prescription drugs have risen at a slower pace the all other medical care (physicians, hospitals, etc.). In addition, Pharmalot has published a number of reports (http://www.pharmalot.com/2008/07/americans-are-cutting-back-on-prescriptions/) from IMS Health and Kaiser citing almost flat growth in pharma sales this year.

On the other hand, according to members of Congress, Humana is getting a 13% overpayment from the government for all of its Medicare Advantage enrollees. But they don't bother mentioning that as a major contributor to increasing healthcare costs.

Atlex

This is great company propaganda - numbers can be manipulated to "prove" all sorts of things. But their numbers are not consistent with the most widely used data source - the National Health Expenditure Data from the Federal Department of Health and Human Services.

I've written about what these numbers show and how they've changed over time(and used some simple pie charts) - see http://www.healthpolcom.com/blog/2008/08/04/national-health-spending-%E2%80%93-lots-of-confusion/

In particular, I would like to point out that prescription drug spending is about 10-11% of health spending, not 15% It is possible that Humana boosted the percentages in their video by ignoring spending on research, construction, public health and some other areas - but that doesn't really paint a realistic picture of where our national spending on health care is going.

Micheal, Is it possible that you are missing a major part of prescription drug spending? on your blog you note that the 10-11% only includes outpatient prescription drugs and not hospital spend on drugs but some of the more expensive biologic medications are done by infusion and those are paid for by hospitals? Some of the billion dollar drugs out there right now are biologics- and are administered in a hospital setting

http://healthguideusa.org/health_statistics/prescription_drug_expenditures_share.htm

Prescription drug share of national health expenditures is around 10%.

PR Hack,

On his site, Michael mentions that drugs costs for hospitals are quite limited, even when high cost drugs are considered. Even when you include all drugs delivered via retail, physician offices and hospitals, pharma accounts for <12%. For a Humana and other health plans, drug costs probably are higher than that since we all know that insured persons spend more on drugs than the uninsured. However, Humana passed these numbers off as national numbers regardless of insurance status.

Atlex

I agree with atlex ... Humana shifting the blame to drug companies. For a talk I gave about 1-1/2 years ago, I found that prescription drugs account for only 5.5% of the total health care spend in the USA.

I wonder how fat Humana's margins are? Insurance companies make a mint ... even if they are a non-profit insurance company, they still have to maintain a reserve fund that will cover 6 months of claims.

Humana probably made this video because brand-name pharma companies didn't negotiate prices with their wholesalers/distributors this year, so the wholesalers/distributors can't pass on any savings to the ins companies. So, of course, this video is how Humana punishes pharma companies. (Esp. since Obama's new chief of staff, Rahm Emanuel, has been highly critical of pharma companies profits in the past.)

The economy is bad for everyone, and Humana needs to adjust their forecasts and executive bonuses instead of throwing a temper tantrum against drug companies.

The most-glaring omission from this You Tube video is the fact that -- while about 13.4 percent of drug company spending goes to R&D -- fully 24.4 percent goes to drug PROMOTION.

Or, put a other way, $61,000 for every doctor in a position to write any scrip -- in 2004.

Let's talk about THAT, eh?

Cheers!

See more -- at mine. Please excuse the above typos -- I'm iPhoning this in!

Heh!

Namaste

Condor, Please provide references for that statement. SEC filings indicate that ~20-30% of pharma income goes towards "sales and administrative" costs. I believe that you incorrectly assume that the "administrative" costs are negligible.

Hey Nathan -- See the top-post on my blog -- click my name to go there.

Read the pull quote, and the link inside it.

The research is right there. Cheers!

Thanks for the link Condor.

Here's some holes in those numbers: 1) They ASSUME that there is 30% under-reporting of promotional activities. They, therefore add 30% to the total amount they came up with (~$45 billion) to arrive at thier final figure ($57 billion). 2) By thier own admission only ~$4 billion of this value goes to DTC ads. Only ~$0.5 billion goes to journal adds. 3) A full $15 billion of this figure is for free samples. How do they arrive at this? They take the number of pills distributed and multiply by the retail value of the pills. We all know that cost of goods for pharma is only ~5-10%. So about $2 billion is a better figure here. 4)The authors of this study are no more unbiased than those of us in industry. Look up some info on Joel Lexchin and you'll clearly find that he has a history of antipharma publications - in particular anti-DTC. See the affadavit below for an example (look at points #11 and 12). This doesn't mean he's wrong, but it does mean he has an agenda to push.

http://www.whp-apsf.ca/pdf/health_can/HCaffidavitsLexchin.pdf

Nathan/Condor,

Take a look at the underlying report. The authors make a boatload of wild assumptions that can easily be challenged by any accountant familiar with the pharma industry. While they are specific in stating that they are not receiving any outside funding, when you examine each authors list of publications, they no doubt have an anti-pharma agenda. That alone doesn't make their work wrong, but the is obviously a bias there.

Atlex

What a crock of B.S.

I like how Humana deflects blame onto consumers - we need to lead healthier lifestyles; we need to quit suing doctors, so their malpractice insurance will go down - and then there's the dreaded, but unspecified, "INEFFICIENCCIES".

Humana could reduce our healthcare costs if they really wanted to. Humana could pass on to their customers, the kickbacks they're paid by manufacturers.

Maybe if Human quit violating RICO, other companies would follow.

Maybe PBMs would pass on to their customers, the kickbacks they receive for administrative services they don't provide and for hitting performance targets that are based on profit rather than the health of their customers.

Maybe Distributors would start charging fees for their services that reflect the true value of their service, rather than a percentage of inflated drug prices that bare no resemblance to actual costs, and that are intended to incentivize them to sell drugs at the highest possible price.

Maybe GPOs and pharmacies will begin to pass on to their customers, the kickbacks they receive from manufacturers when they hit performance targets, and the increased margins they receive when they sell drugs they purchase on the grey market or divert into the grey market.

Maybe Pharmaceutical manufacturers will quit defrauding Medicaid and Medicare, and start reporting accurate prices for the drugs they sell, and maybe they'ee pay rebates to Medicaid as required by federal and State laws.

Maybe the Mobsters that run the Pharmaceutical Criminal Enterprises will be rounded up and thrown in jail.

And maybe this year I'll finally get the pony that I ask Santa for every single Christmas.

Hey Nathan (and Altex) -- I am put in mind of the adage made famous (once again!) in this election cycle: something about "lipstick on a pig. . . ."

Let us accept that $45 billion is the "right number" for all-in promotional spending per year. Or even $30 billion. With a BIG "B".

Please explain why it NEEDS -- yes, "needs" -- to be more than $10 million. Yes, I mean that: 10 MILLION, with an "M", not $25, $23 or $47 billion, with a "B" -- we are talking about PROMOTING a drug -- where is the incremental social utility of that expenditure, for even the figure of $25 billion?!

We are NOT simply talking about releasing a series of re-prints of NEJM for doctors to read -- and that, fundamentally, is a BIG PART of what's wrong with pharma. "We, the people" -- the "we" in this case, being all the consumers and taxpayers -- shouldn't be funding those costs -- with our remibursement dollars. The dollars which pay the drugmaker for its assorted wares.

Pharma talks about getting "message points" into all sorts of places (not just DTC, Nathan) -- in booths, on jets, into mugs, lobster banquets, junkets to Sanibel Island [and, DO note here, Ed's other column today on the INEFFECTIVENESS of the Schering Vytorin campaign, on this front].

Why aren't we talking about that? We ought to be. Don't distract us from the real issue by suggesting the number is perhaps even 30 percent too large.

It is probably a hundred to a thousand times more than we "ought" to be willing to subsidize -- with the monopolies of patents and FDA approvals, as barriers to entry in this market-place.

Please discuss.

Condor,

Why do they spend so much...because it produces a return on investment. That's the fundamental reason why any industry markets its products. Like it or not that is also capitalism. Why single out pharma? Why not go after doctors, lawyers, hospitals, food manufacturers, bloggers, etc.? Hell, why not go after politicians? Shouldn't voters just choose based on the positions of the candidate and not on how much money they spend to deliver their message?

As for the ineffectiveness of Schering's campaign...guess what, it is hard to put lipstick on a pig. You have to have a fundamentally sound product to be successful over the long term.

Our system--warts and all--has produced amazing innovations. If you have a better way to produce and market pharmaceuticals, go for it.

Atlex

Actually, Atlex -- We all do have a "better way".

And so we are clear, here -- I am a very firm capitalist. A believer -- but a rational one -- governed by reason; not just greed. So, I just think there are some markets (like pharma) where the "truly free" market has been tipped too far in FAVOR of industry, and away from the buyers. It is thus NO free market.

And I have had this discussion before here, about "why pharma?" -- just ask Nathan:

Pharma enjoys two monopolies [(1)patents, and (2) FDA approval processes] -- and a third, naturally-occuring advantage -- (3) its products are almost-entirely "opaque".

We cannot know whether they are good -- or bad -- for us, without expert help. UNBIASED expert help -- yet we let pharma put its fingers on the scale, and try to sway doctors.

That is unsound from a policy perspective.

So -- to suggest that I NEED to have the drug products "pitched" to me (or to any doctor, even) is simply nonsense. Rubbish.

Science alone should sell drugs -- not clever Madison Avenue spin-campaigns. We have the right to demand this -- given the monopolies we've allotted (as a policy choice) to pharma.

Now, as we move toward universal coverage, my voice will be amplified by more and more Senators and Reps. (beyond Baccus, Kennedy, Conyers, Waxman, Dingell, Stupak and Grassley), and the President, himself -- to end the taxpayers' subsidy of these "pharma marketeers' expenses". I can guarantee it.

Trust me. That is where this train is going.

Just watch -- it is pulling out of the station, tonight -- with Sen. Max Baucus' first proposal (press-released this very morning) for mandatory, universal coverage.

Buckle-up, and Cheers!

Not sure what difference it makes, but here is what Chemical and Engineering News said in 2006 about the percentage of healthcare that goes to pharmaceuticals. It appears that the Humana number might be an _under_estimate:

Meanwhile, according to the federal Centers for Medicare & Medicaid Services, total U.S. expenditures on health care were nearly $1.9 trillion in 2004, or 16% of gross domestic product, and more than two-and-a-half times the $717 billion spent in 1990. In the same period, 1990 to 2004, retail sales of prescription drugs increased from $40.2 billion, or 5.6% of total health care spending, to $190 billion, or 10.0% of the total.

"The 10% number is based on old data and does not include drugs dispensed in hospitals, clinics, and other nonretail settings," says Stephen W. Schondelmeyer, an economics professor at the University of Minnesota who studies drug pricing. "The data today show that prescription drugs in all settings account for about 19% of total health care dollars."

Condor writes: "Science alone should sell drugs — not clever Madison Avenue spin-campaigns....to suggest that I NEED to have the drug products “pitched” to me (or to any doctor, even) is simply nonsense"

Are you just picking on pharma here, or do you also advocate elimination ALL advertising to physicians about new technology? Forgot about advertizing that newfangled MRI or ultrasound technology. Forget about the new blood tests and genetic tests available. Forget about the new adverse event monitoring software. None of it can be advertized to doctors. Right? That IS what you are saying, right? We (as patients) should simply expect that our doctors are reading the primary literature to find all about the latest and greatest technology.

I'll let you live in that world, Condor. I'll live with the evils of advertising.

Hey Nathan -- I guess you missed the part about simply reducing the kinds, and amounts of advertising -- my earlier comment suggested reprints of peer-reviewed independent journal articles -- and suggested that spending of something like $10 million per company might be more in line with simply "getting the word out" on a study.

In any event, I would not automatically extend these limits on advertising to medical device makers. That would require a more nuanced thought-process -- one we ought to begin working through.

Drugs are "opaque monopoly" goods -- and "utility" (i.e. required) goods, at that. That is, if they are well-made, and supported by independent science, as to safety and actual efficacy, they are utility goods. So, all this yammering on about "leaving" these markets as entirely "free markets" -- is muddied-thinking, at best. It is deceptive and dishonest, at worst.

It ignores reality. It simply ignores the monopolies we've created -- and the advantages any monopoly confers upon the industry.

Please explain why drug monopolies need to do consumer advertising.

Namaste

The fact that you think we have a monopoly is rather funny to me. We have a monopoly on an individual product. That's kindof like saying that Honda has a monopoly on the Honda Civic. Of course it does - but so what? We can choose from any number of similar cars.

The notion that drugs are clearly differentiated by science is naive. There are lots of different drugs to treat asthma. Which is best? We don't know. We all CLAIM ours is best – but usually no one has done side-by-side comparisons. If my company invented a cure for Alzheimer’s tomorrow, then I would agree that we need no advertising. There is no competition. It's a pure monopoly. Nobody else can cure it and the science alone will sell it. (this is partly why companies are refocusing on Alzheimer’s and cancer)

But generally that isn't the boat we are in. We are trying to sell products that compete with other products on the market. We are also trying to convince doctors and patients that treatment is superior to non-treatment. Sure, people COULD live with ED, RLS, headaches, PMS, GIRDS etc, etc. etc. But we (as drug manufacturers) try to convince people that the cost of treatment is worthwhile - that they don't HAVE to live with the afflictions that ail them.

A clever dodge, to be sure, Nathan.

We at least argee on this much: you don't know whether your products work.

We need independent scientists to sort that out, if we are to make headway here.

But to recast this as a debate over whether to treat disease at all -- is dishonest, and beneath your abilities -- and my intelligence.

Do try to answer the question next time.

Cheers!

Condor please read before you write. You say: "We at least agree on this much: you don’t know whether your products work."

Re-read what I wrote: "The notion that drugs are clearly differentiated by science is naive." Efficacy is proven. COMPARATIVE efficacy is not. You have to think a little deeper.

Condor writes: "But to recast this as a debate over whether to treat disease at all — is dishonest, and beneath your abilities — and my intelligence."

You asked why we bother advertising. I gave you a clear answer. You can call it beneath your intelligence if you like. But that's reality as I see it - not dishonesty. If you disagree with my assertions, please don’t insult – please respond.

Nathan writes: ". . .That’s kind of like saying that Honda has a monopoly on the Honda Civic. Of course it does -- but so what? We can choose from any number of similar cars. . . ."

Except, of course, Nathan, we can test-drive a Civic, or Elantra, or BMW 5-Series.

How do we test-drive your products?

Oh. Right. We trust our doctors to figure that out for us -- most of the time, with our very lives on the line.

Once again, your arguments here (as elsewhere) prove too much -- and, by more than half.

QED

This is an interesting discussion and there are points on both sides.

Right now the balance is tipped too far in Pharma's favor. As to the amounts spent on promotion I seem to recall that there was information that even PhRMA was admitting that it was about double the amount of R&D, and this is likely an underestimate as those of us who have been in R&D know that a lot of studies and payments to docs under R&D costs are really seeding studies and to buy influence with key opinion leaders. This is blatantly obvious if you even look at what companies pay true experts for their input. The daily rate for those from the US where they can help with sales are 10x the rate for bigger experts (and more useful ones) from the UK where there's more government control of sales and reimbursements.

In addition the opacity is increasing. I'm personally afraid to take new medications as the last three NMEs I've worked on had high incidences of extremely serious side effects that FDA management actively tried to coverup and prevent the reviewers from finding out about. I also wonder about a fourth, but that may have been the company withholding info pre-marketing and not FDA management interfering (at least not pre-approval).

I didn't become cynical about FDA overnight, even before these last 3 meds I had caught a number of drugs with lethal side effects and had tried to work internally to raise the flag, twice stop the drugs, but more typically get appropriate warnings and labeling prior to approval. I had always thought that well they're making a decision and although I don't agree I could be wrong and it has been vetted. But after numerous examples where I turned out to be right every single time and drugs either had to be yanked from the market or black box warnings imposed, and the same sorts of problems came up with new NMEs where I was fighting the same fights again (but being intentionally sidelined). I came to realize that the internal 'experts' were really just there to overrule any concerns of reviewers. Then if they can't do that then they retaliate and remove you from being involved in the reviewing of the drug.

This does not mean that I would have recommended non-approval. But for me to recommend approval I would have to have full access to information (which clearly was suppressed by companies and FDA management) and that I had been able to weigh all the information, present it publicly to an advisory committee, and then label it so that those who might have benefited would know who they are and how to take it appropriately and those who should avoid that medication would know who they are.

Unfortunately appropriate labeling of medications decreases the uptake of a medication into the market place. Companies don't want this. They'd rather sell as much as possible, let people get harmed, and then deal with the consequences later. Which typically means having FDA run interference and using every possible legal tactic to avoid responsibility.

We could probably have a lot more drugs approved or approved sooner if the opacity was removed and appropriate risk communication was allowed. This last might even need to include published articles outlining what we reviewers truly know and don't know and our impressions of likely appropriate initial usage of the drug.

I know that some people will take an increased risk of death for relief of a mildly discomforting symptom, other people won't. Isn't it up to the patient themselves to make a valid risk assessment and what they are willing to live with?

Drug development is extremely difficult (I often see by comments posted that even those in industry don't appreciate how difficult it really is with respect to other disciplines) and a prescription drug by its very nature is unsafe unless used appropriately and will have safety issues even then. The way forward is to come clean to work together honestly, business as usual cannot be sustained.

Nathan writes: ". . . .Efficacy is proven. COMPARATIVE efficacy is not. You have to think a little deeper. . . ."

With all due respect -- as to many FDA approved drugs -- efficacy (let alone comparative efficacy!) has NOT been PROVEN.

And while we're on the subject -- why don't all you smart pharma guys take some of your marketing budgets' BILLIONS -- and run INDEPENDENT, TRULY-comparative efficacy trials -- post FDA approval? On any class of two or more drugs, for one condition or disease.

Oh. Right. Again. -- That might weaken one drug's permissable CLAIMS -- in advertising.

Pharma is afraid of comparative studies.

It injures the monopoly's power.

Here endeth the rant.

As businesspeople I ask you to think about the old business adage: Would you rather have 100% of nothing or 10% of something?

Condor,

I as to efficacy not being proven, this should be a more nuanced answer. Efficacy to endpoints are proven. This may not however be relevant to what's clinically important (e.g. biomarkers) or be great enough to offset the risks (e.g. death due to drug when there's a a presumed higher death rate off drug).

During development comparative studies in some therapeutic areas are done. For example it's standard practice in psych and some forms of cancer. However, this comparative data is typically not included in the labeling as it may set a precedent for manipulations in the future. In some cases this comparative data can show that that there's safety problems with an already approved drug that's not appreciated.

I believe that reviewers should be required to publish their reviews and all but manufacturing methods and finanical data should be made publicly available. If a company wants to market a drug then all data relevant to safety should be made publicly available. This should also extend to significant safety issues with drugs that were dropped. We should not be exposing people over and over to unacceptable risks that we already know about. This would also allow companies to avoid wasting of resources, so they can terminate development sooner if they see something that is a concern. Alternatively it will give them a benchmark on which to judge whether their compound it is not as much of a problem for.

Condor writes: "Pharma is afraid of comparative studies."

That's partly true -- but it's also a vast oversimplification. When doing a comparative trial, you have to think about these issues: 1) WHAT competitor's compound do you study? The best in the current market? The one with the same mechanism of action? The one that is awaiting FDA approval? You can't do comparative efficacy against all of them -- you'll have to just choose 1. Phase III trials already cost $100 million or more. You are talking about possibly doubling the price of that. 2) What dose do you look at in the competitors compound? Many drugs are given in escalating doses UNTIL they work (think CNS drugs). This would be NIGHTMARE for comparative efficacy studies. What if my drug at 10 mg is better than the competitors at 20 mg. Does that make it a better drug? Maybe, maybe not. It depends on the safety at those doses. 3) What class of patients do you look at? The ones in the original clinical study or the class of patients currently taking the drug? The results could be very, very different. What if my new drug is targeting a different subpopulation? Should I still do comparative efficacy over the standard of care? 4) What do you do with the side effect issue? Many drugs will have comparable efficacy, but a different side-effect profile. What do you do with that information? Is it useful?

In spite of these issues, I do see pharma moving more towards comparative efficacy. Governments and insurance agencies are refusing to buy products unless they are superior to the existing standard of care. And the FDA is moving towards only approving products that bring a significant advancement in efficacy or safety. But so far, no one is doing real "head-to-head" trials to make these judgment calls. (to my knowledge)

Nathan,

While I agree whole heartedly with points 1 - 4 I vigorously disagree with the statement

"the FDA is moving towards only approving products that bring a significant advancement in efficacy or safety".

This is propaganda that is being promoted by the drug companies. Even if a drug is somewhat less efficatious or somewhat less safe we have to approve them.

In my highly informed opinion some of the drugs that industry has used as examples of this in truth had major safety or efficacy issues that they just happened to get caught on. But then Pharma doesn't release the nonapprovable letters or the data and even if they did the letter can be written in such a way as to largely avoid the real reason for non-approval. The FD*CA require meetings to be held with FDA after a non-approval to discuss what can be done if the sponsor wants to pursue the drug. Reviewers who raise those safety/efficacy issues can and are excluded.

These actions allow companies legal recourse to get unsafe drugs approved. So if you see a CEO of a drug company complaining about this issue in the press as it pertains with their drug. Then that's a redflag. It's kind of hard to go and look at these things retrospectively without knowing the specific examples, but it can be done.

FDA Reviewer writes: "the last three NMEs I’ve worked on had high incidences of extremely serious side effects that FDA management actively tried to coverup and prevent the reviewers from finding out about."

I can see how management might work to suppress bad news from the public, but less clear on how that would happen with reviewers. Can you clarify? Does this mean withholding data from reviewers themselves or dividing it up in such a way that the 'big picture' is not apparent to any pair of eyes?

Both. There are also other tactics management and companies can use. Minimizing review time. Agreeing a priori to study designs that minimize the chance of picking up on the AE. Ordering reviewers a priori not to review particular studies, claiming that they're superfluous/ When they know from the IND process there was a big safety issue identified in that study. Not telling reviewers that similar problems have been observed with other drugs in the past, and then when picked up on totally dismiss that it's even possible. When problems are picked up having other review disciplines writing counter reviews that dismiss the concern. Ordering the experts in that particular safety issue (e.g. cardiologists) to base their assessments on the sponsor's front end summary and not to look at the actual data including cardiologist's reports. (Telling reviewers the same.)

Misdirecting reviewers early as to what is important and what they should be focusing on. (Would you spend a lot of time analyzing if the poor bioavailability when this buccal formulation is swallowed decreases efficacy, when it's really metabolized to a toxic compound.) Telling reviewers not to analyze the exposures to metabolites in drug interaction studies when it's the changes in metabolite exposures that results in the toxicity. When data is requested not forwarding the request to the sponsor. Intimidating reviewers by saying the request isn't needed "it's nice to know, not need to know" (if I'm going to change a recommendation based on the information then it's need to know). Reassigning reviewers. Have a different reviewer work on the NDA rather than the one who worked on it all along during the IND. Divying the review up and then have the 'consult team' intimidate and harass the reviewer and prevent the reviewer from meeting deadlines or even seeing the raw data.

Set up database systems for the study data that reviewers aren't familiar with and refusing to provide any useful training so they can actually look at the data.

During presentations of the review findings tie up the entire time by focusing on a minor discrepancy so that the reviewer doesn't have time left to present safety concerns, and then penalizing the reviewer to trying to refocus the presentation and for what they did/did not present.

Have multiple meetings with the reviewer and 6 managers where the reviewer is relentlessly attacked and then claim that a concensus was reached.

Exclude reviewers from meetings with sponsors about their area or concerns.

For problems that may be related to special populations such as children or the elderly, or with longer duration not have review of these studies part of the original NDA submission and then the day before the deadline ask the reviewer to quickly review the studies (inadequate time to do other than a cursory look at the study and no time to properly analyze the data.

Help companies by directing the trial design e.g. in comparative trials so they can say it isn't worse than already approved drugs, but the approved drug probably is so bad it should be removed. Tell companies that they can get an indication for combination therapy by studying drug A with drugs B and C when there's a lethal reaction with Drug D that will certainly be used in combination.

Claim a constellation of AEs that point to a single mechanism aren't related. Scheduling meetings, etc. when the reviewer is out of the office. Tell reviewers they don't need to attend certain meetings when it turns out they know there's something that will be presented that might tip off a reviewer to an issue in their area. Force the reviewer to complete their reviews before they can see information from other review disciplines that by nature the second review discipline builds on, e.g. medical reviews before clinical pharmacology or clinical pharmacology before pharmacology or consults.

Dismiss mechanisms (you can't call a drug hepatotoxic when the person also has evidence of viral hepatitis, even though all the scientific evidence indicates that this will make the drug induced hepatotoxicity worse).

Telling clinical pharmacologists they have no business looking at formulation, safety, efficacy, or basic pharmacology, and then intimidating other review disciplines not to look at the these issues and preventing disciplines from working together.

Wow! What a list - and what a service to include it here. Thank you.

I believe that some version of this list should be nailed to the door of anyone who makes the usual claims about FDA's independence with regard to preemption (and a lot of other things).

It's in my permanent file. Again thanks.

I hope you can inform people in Michigan who may be able to do something and not just have it sit in a permanent file.

Remember I may have taught you everything you know about what goes on inside FDA, but I haven't taught you everything I know.

An FDA Reviewer

The richness of this dialogue is why Ed's is the "go to" destination for inside pharma baseball -- not a singel doubt about it.

Thanks again, for yours, FDA Reviewer -- and JiM -- I've saved your factiods about the likely "under"-estimation of pharma spending.

Great stuff!

FDA Reviewer - I've been working to inform folks in Michigan - home of the most regressive liability shield law in the country - every day, for most of the past five years. And I have learned what I know from a number of people who have "experience." Enough said.

The "file" doesn't sit unused.

My understanding of SG & A expenses:

50%=Samples 30%=People 20%=Actual Promotional Spend

*DTC comes out of the 20%, probably a third *Yes, total SG & A > R & D *R & D 8-10X >DTC

Guess the company: Net Sales: 74B Net Income: 9.8B SG & A: 7.8B

Answer: Phillip Morris

One thing that I noticed in this video was that they didn't answer their question: "Why is health care so expensive?"

Telling us what part of the dollar goes where does not explain why office visits are $200 if you pay yourself but the doctor will take $80 ($60 from the insurance co. and $20 co-pay) if you have insurance. It doesn't explain why you can order a lipid panel over the internet (from Labcorp)for $45 and if your doctor orders it, it will be $65. It doesn't touch why a LEEP (sp?) procedure is billed at $2000+ but the doctor will take $700 from your insurer.

We need way more transparency in medical costs and billing! Why can't doctors post their fees? Why can't hospitals and labs post the costs for their services? Why are hospitals expanding at an almost relentless rate?