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Health Care Costs and Universal Coverage

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In yesterday's Dispatch, I detailed some of the innovative laws states have been enacting to stop profiteering by drug companies, end fraud by hospitals, eliminate self-dealing by doctors, and enforce more accountability for heatlh care costs by providers.

What is clear is that ultimately, the fragmented for-profit nature of the health care system lies at the root of why the United States spends fifty percent more of our annual income on health care than the average European country (15% of GDP in the US vs. 10% of GDP in Europe) and yet health outcomes in the United States place it thirtieth in the world, behind Singapore, Chile, Costa Rica, Japan, and every Western European nation.

A lot of noise is being made about using technology in health care to cut costs and improve health care results.  A 2005 RAND study estimated that full implementation of so-called Health Information Technology (HIT) could save $77 billion in costs annually across the country through better coordination, less time spent on administration and better drug utilization.

Unfortunately, as the RAND report notes, there is "no market pressure to develop HIT systems" between all the fragmented parts of our health care system -- one reason a strong government role is no needed.

That fragmentation of the health care system lies at the root of much of the waste and fraud in our health care system.   Each player tries to pump up profits and often waste through excessive billing of third parties. Each party avoids taking responsibility by shifting the increased costs onto government or other third party providers. Short-term profiteering means long term investments in preventive care or technology gets shortchanged.

A recent Business Week profile (read the whole article at the link) of the Veterans Administration health system emphasized that an integrated health care system like the VA can accomplish savings that the rest of the balkanized for-profit health insurance system cannot.  

After reforms in the 1990s, the 154 hospitals and 875 clinics run by the VA now rank as best-in-class on health quality, on measures ranging from quality of chronic care to percentage of members receiving flu shots to having a prescription accuracy rate of 99.997% (compared to a 3% to 8% inaccuracy rate more generally).  According to research by the University of Michigan, the VA now outranks private-sector hospitals in patient satisfaction.

And the VA delivers this quality at a cost of $5000 per patient versus a national average of $6,300.

How does it achieve these savings and quality?  According to Business Week:

  • Not having to rely on piecemeal insurance payments means the VA can finance large-scale improvements such as the electronic medical-records system, up and running in all of its facilities since 2000-- compared to just 20% of civilian hospitals with computerized their patient records. When hospitals were evacuated from New Orleans during Hurricane Katrina, the VA's patients were the only ones whose medical records could be accessed immediately anywhere in the country.
  • Because the VA treats patients throughout their lives, it can invest in prevention and primary care, knowing it will reap the benefits of lower long-term costs. Because the government pays the bills, the VA doesn't have to waste time or money on claims-related paperwork.
  • Unlike Medicare, the VA is allowed to negotiate prices with drug companies and other suppliers, and it uses that power aggressively. The consumer group Families USA estimates that Medicare Part D enrollees, on average, pay 46% more than the VA for the same drugs.
  • And because its doctors are salaried employees, the VA can implement systemwide changes without having to persuade outside doctors to go along (and without doctors having a financial incentive to undermine reforms by self-referrals or other profiteering).
  • The VA uses the data gathered in its computers to pinpoint problem areas, such as medication errors. The network also allows it to track how closely the medical staff is following evidence-based treatment and monitor deficiencies.

States can and will continue to pursue piece-meal reforms, but as they seek to achieve more universal coverage, as we discussed in a recent Dispatch, they can take lessons from the VA and begin ending the fragmentation of health care systems in favor or encouraging more integrated and publicly-accountable health care systems.

As I've argued, states are not likely to achieve the level of integration of a completely publicly-run system like the Veterans Administration right away, but by simplifying and integrating health plan options across employers and the public sector, states can create more of the accountability and cost savings that in turn can help finance those broader health coverage goals. 


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I hypothesize that market forces break down in the face of inelastic demand. Why is it that progressives, by and large, dislike "privatization"? I believe that we are perfectly happy with "free market" management of products and services that we can do without if no provider can deliver appropriate value.

Basic services are (mostly) inelastic: Medical services, basic utilities, and for those needing to earn a living, transportation.

In the last few decades, there has been movement to "privatize" essential services world wide. When these services are natural monopolies, or are fiat monopolies, the providers tend to raise prices until teceiving negative feedback through some force other than traditional marketplace forces. Medicine, for example: It's pay a price set by the medical cartel or take your chances.

It seems that our society has been persuaded that "the marketplace is the one and only way to maximize efficient use of the resources". That statement is treated by certain elements of our society as axiomatically true, and the rest of the population is stuck with the results.

I hypothesize, therefore, that societies must be prepared to provide the feedback that is lacking in natural or fiat monopolies. The medical (and insurance) cartel in the U.S. is a perfect example of the structural inefficiences that arise when inelastic demand meets monopoly.

Medicine, for example: It's pay a price set by the medical cartel or take your chances.

Well yes and no.

Most every drug developer in the world targets approval of experimental new drugs in the U.S. despite the Byzantine nature of political science at the FDA which doesn't do much math and science. There is even some concern among political types over a cancer drug developed in Cuba.

Despite the horribly inefficient and costly nature of American health care, the U.S. remains a mecca for drug development that can potentially reduce health care costs drastically, not to mention saving lives and health.

The trouble is, of course, that exorbitant pricing of drugs by a Merck or Pfizer is not necessarily the best way to encourage small biotechs to develop revolutionary new platform drugs that must overcome superstitious dread and hostility at the FDA, if not outright corruption.

Few liberals seriously address the imbalance while offering only the absurd notion that buying drugs from Canada or other countries will solve the problem.

My Mom was a VA nurse, she'd tell you the reason why the VA is cheaper is due to the fact that they cut way back on Nursiing staff.

;-)

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It's a classical response to a perceived problem... Fix the perceived problem:

Few liberals seriously address the imbalance while offering only the absurd notion that buying drugs from Canada or other countries will solve the problem.

Many people are simply *completely out of luck* in trying to choose between the rock and the hard place. In the case of the drug price problem, Americans see that they are paying significantly higher prices for drugs than our neighbor to the north, or the neighbors across the Atlantic. So they draw the obvious conclusion: Our neighbors pay less, why can't we? Many of the people advocating the border-crossing "solution" have answers that, for them, are far from absurd. It's their only option, considering both the significance of the price differences and the fact that too many people cannot afford American prices.

Notice that I didn't offer any ill-thought solutions to the problems that I think I see. The reason is that the reality is complex enough that I am not qualified. (My qualifications begin with assembly language and end approximately at JavaScript, plus or minus a few layers...)

I agree that there's a balance to be struck. However, there is something very important missing from the general discussion: Real information about how the American medical dollar is really distributed. I believe this information is protected very carefully by industry players, which prevents those of us in broader society from making informed choices.

Therefore, what I do advocate, and relatively strongly, is that we as a society are allowed to be informed, such that we can collectively make well-informed choices.

"Free markets" only work when their various participants are freely able to make properly informed choices. Markets that limit access to information are not free. Markets in which some participants cannot make choices are not free.

Nonfree markets are structurally inefficient. That inefficiency translates to a transfer of wealth from those who are not informed, or cannot choose the extent of their participation, toward those who manipulate the marketplace.

This is why I originally brought up the issue of "privatization". The problem arises when we combine profit-making entities with situations where demand is inelastic, or when a few players have monopolistic or nearly monopolistic influence.

With respect to the question of the medical industry, we (think we) know that we are paying much more for a set of products and services, but receiving what appear to be lower quality outcomes in exchange.

So, are we permitted to discover the various sources of inefficiency in the system? And what's the best way to manage our resources appropriately? There is some very very big money at stake here, and there are people who don't want to get kicked off the gravy train. This is why I refer to the industry as a "cartel": One way or another, they have established a situation where the providers of the services (insurance, medical industry, big pharma, etc.) have many choices, but we their customers have only one: Pay or take our chances.

BTW... I believe the substandard Americsn outcomes are not *all* the medical industry's fault here. IIRC, Americans are the world leaders in unhealthy lifestyle (not enough exercise, too much of the wrong kinds of food, too much stress).

 Real information about how the American medical dollar is really distributed. I believe this information is protected very carefully by industry players, which prevents those of us in broader society from making informed choices.

Asymmetry of information is a fundamental problem as you say.  One entity within the health care delivery system that has all the information one would need to make an informed choice is the health insurer.  They have the providers' fee schedules, their quality of care levels and patients' medical histories .

Employers, because they purchase insurance, also have access to this information whether they self insure or not.

Doesn't that make you feel good?

Right, and the HIPPA laws that are supposed to protect us from having our medical information given out...

Just try to get health insurance without waiving your HIPPA rights. If you refuse to give them the info, they refuse to insure you.

So, you give them the info, and once they see that you've ever been actually SICK, your premiums go way up, and so does your deductible and co-pay. (Unless you are a part of a large employer-based policy)

Is that providing health care? No that is providing the insurance companies with an assured profit.

Jan Knaus

The insurance companies are in business  to make money.  That they have done to the tune of hundreds of billions of dollars over the past 35 years. 

The "kiss of death" so to speak occurred when the Blues converted from not for profits that were obliged to "give back" to their communities in exchange for that preferred tax status. This usually took the form of community rating.

The move to experience rating is, as you describe,  a premium based on utilization. This is essentially funding your own care.  Some would justify this by saying it still insures against the "high cost low probability event."  The only "break" you get is if you are covered by an employer group and then your premium is based on risk spread across the group's utilization. 

But... your employer knows everything about  your health and may, if you are a high user, make your individual premium reflect that use.

By now you are probably not feeling so good, right?

...health outcomes in the United States place it thirtieth in the world, behind Singapore, Chile, Costa Rica, Japan, and every Western European nation.

By what measure? I saw one stat that we were number one in recovery from cancer and heart attack.


The sons of the prophet are noble and bold,
and quite unaccustomed to fear.
But the bravest by far in the ranks of the Shah
was Abdul Abulbul Amir

Price competition is fundamental to the capitalist system. Competition for customers leads to the right price for product and value. Such competition, however, is anathema to health care. Why? On one hand we have government sanctioned monopolies which allow patent holders to charge whatever they want for a product for a generation. This severely limits competition. On the other hand, we find it difficult as a society, as health providers and as consumers to place a monetary value on health care, a surrogate for life. We don’t shop for value.

Costs for new cancer drugs have increased ten fold since the early 90's and are at a 40 times (or more) the levels of the 70’s. It's not unusual now to be paying $5,000/month or more for a drug alone. Patients with cancer perceive that they face the ultimate dilemma—pay or die. Cancer pharmaceutical pricing, as a result, is a death tax, a system that redistributes wealth rather than assures quality care at reasonable price.

A single payer system approaches some the issues, particularly those of duplicated administrative costs, but does not answer the problem of the costs of new technology and drugs. For that we should:

1. Require the government and pharmaceutical companies negotiate prices for patented medications purchased for government programs and benficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparancy we should make the negotiated prices public.

2. Enforce the reasonably pricing provisions of the Dole-Bayh Act. Retrieve the taxpayer’s contribution to drug development costs (approximately 20 billion a year to basic medical research) from patent holders and use these proceeds to defray pharmaceutical prices to consumers. This would also require the disclosure of the real development costs of pharmaceuticals.

3. Prohibit direct to consumer (DTC) advertising. In a 30 second ad full disclosure as outlined below is not possible. As a result patients do not fully understand the limits and costs of any given product. Few countries allow such advertising.

4. If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of proven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer.

5. Require clinical studies include cost data as well as a measure of cost effectiveness (QALY-Quality adjusted life year or other) in the discussion of any phase II, III or IV study reporting positive results.

6. Monitor the FDA approval process to be certain that generics come to market quickly on patent expiration.

7. The Canadian system controls patented drug prices by not allowing marketing unless the drug is priced right. A similar program could be instituted here to decrease our pricing to the level of other industrialized countries.

8. Alternatively, link the length of patents to reasonable pricing. As part of the FDA approval process the proposed price of the new medication would be compared with similar medications already on the market and with the same medication in other countries. The same process that the Canadian patent drug review board uses. If priced 10% over the comparator, the patent length would be decreased by a similar 10%–there are many ways such a link could be structured. For unique innovative drugs the cost of development could also be factored into the pricing length of patent equation. Price increases during the duration of the patent would be tied to the rate of inflation. If they exceed that rate the patent would be proportionally shortened.

www.medicynic.com

I don't think it's fair to assume that insurers have all the information needed for informed healthcare choices. Medical histories are at best an imperfect indication of a person's medical needs, and only then for the people who go to the doctor regularly.

I recently went for a colonoscopy. I got a bill from the hospital, and an explanation of benefits from Blue Cross. The hospital bill indicated that the total bill was about $5,000, and my share was $500. The Blue Cross explanation showed that the negotiated actual price was about $1,000, and my share was $500. How is this even called a system where pricing is so unknown? I'm sure if I were uninsured, The hospital would be after me for the entire $5,000.

Ceterum censeo Carthaginem esse delendam

4. If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of proven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer.
Let's take this for something where there won't be a measure of life or major morbidity: OTC pain relievers. In the US, we have aspirin, acetaminophen, ibuprofen, and naproxen. Advertisers try to suggest each is best, sometimes with things that are true but not especially irrelevant. Yes, aspirin can help prevent atherosclerotic disease, and an aspirin chewed early in an incident of chest pain may make a survival difference if it's a heart attack (myocardial infarction). But, that's not especially relevant if the consumer is trying to decide what to take for a headache or arthritis.
In my medicine chest, I usually have aspirin, acetaminophen, and either ibuprofen or naproxen, because I know the nuances of when each would be likely to be best for a headache versus muscle pain. I know when to take a larger than recommended dose, and interactions and cautions.
Offhand, I could probably go on for 15 to 30 minutes on the basis for my choice in a specific situation. How much of that can be put on a consumer-useful basis? How much of the differences are significant?
If I had chronic headache, at what point do I realize that treating the headaches may not be as good an idea of taking prescription medication to prevent them? If my pain is from arthritis, at what point is prescription tramadol likely to have a lower side effect profile than some of the OTC drugs?
I honestly don't know where the balance should be in advertising. What level of background should be assumed? Given the way the probability of side effects are presented, many laymen guess the percentages far differently than someone with pharmacological training, even for simple drugs. It amazes me to see DTC advertising for such things as selective blood cell growth stimulants for use during cancer chemotherapy -- the decision to use such things will be argued between oncologists.
Where is the proper ground among banning DTC, expecting the audience to have read and understood Goodman & Gilman's the Pharmacological Basis of Therapeutics or a decent lay health background, for some value of "decent"?

--
Howard

*equal opportunity offense to both extremes*

 Require the government and pharmaceutical companies negotiate prices for patented medications purchased for government programs and beneficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparency we should make the negotiated prices public.

I could not agree more. 

Along the lines of transparency, don't you find it aggravating that insurance companies have a great deal of price data because they negotiate fees for their provider panels, hospitals and free standing clinics as well as prices of pharmaceuticals selected for their formularies?

Ever try to see the contract for coverage during open enrollment and come to find out you have to sign on first before you can see the contract which includes specific information on benefits and exclusions?

You may monitor the FDA with respect to generics coming to market but unless you tell the Senators (Hatch, Dole or the like) to stop legislating extensions of patents it won't do much good.

The delivery system certainly needs HIT; but I don't expect that to change the asymmetry of information between the patient or customer and 'the system'.

 

Cost and side effects, even for relatively inexpensive medications, would meet my criteria for being open enough--if we have to have DTC advertising.

I certainly agree that a sound/video bite can only confuse and provide incomplete information. My preference, therefore, is to not have such advertising for prescription medications--as is the rule in most industrialized countries.

About 3 years ago a retired guy in Virginia filed a class-action lawsuit over that very issue; he claimed that under the T&Cs of his retirement health plan his liability was $50 (in your example). The WSJ had an article about it at the time. I never heard what the outcome was, but I imagine if he had won a law would have been purchased to reverse the court decision anyway.

sPh

Re: But... your employer knows everything about your health

Insurers do NOT share health data with employers. Even self-funded employee benefits have a firewall in place (a third party administers the plan so the employer does not know anything about individual employee claims) to prevent this from happening.

Here's another eaeson for marklet failure in health care: there are no "inferior goods." That is, there are no affordable substitues that will do just as well as the high-priced stuff (generic drugs are about the only exception I can think of.) I cannot think of anything we regularly consume for which this is true: in housing we have a huge spread in price between mansions and studio apartments; in food between Ramen noodles and filet mignon; in transportation beween the bus (or even a bicycle) and a Lexus, etc. But if someone needs an appendectomy, a broken limb set or chemo for cancer than that is excatly what they neeed and there is nothing that can be substituted.

There are several areas where this is not true, for sometimes reasons other than pure price, and, conversely, there are areas where something that apparently was "more luxurious" has practical economies.

It's been fairly consistent that the best predictor of success in cardiac surgery, transplantation, and a number of other areas is to have people and a facility who do a lot of them. If a patient doesn't have such a facility in their locality, or a remote specialist facility is not covered by their locally oriented plan, they may not get the best care. Admittedly, some people, knowingly sometimes, will settle for a local facility because it is less disruptive to their lives.

While there are high-end hospitals that have luxury wings for exceptionally well-off patients, new hospital construction tends to emphasize private rather than semiprivate rooms. Hospital-acquired (i.e., nosocomial) infections tend to be less common with private rooms, and patients often are better rested and have shorter stays when alone.

Related to both the specialty center and the economics of emergency medicine is the capability to have major interventions that benefit overall health. Perhaps the most significant, even more so than in heart attack, are new interventions in "developing stroke". Some physicians are recommending the term "brain attack" rather than stroke, to imply that it is a true emergency where specialized interventions, preferably in the first 3 hours and pretty much limited to the first 6 hours, can reverse damage.

The challenge here is that most "brain attacks" are due to clots, and the clots can be dissolved with prompt therapy. A certain proportion, however, are due to bleeding, and, while there is interventional therapy, clot dissolvers would kill the patient. At the very least, a local hospital needs remote video and imagery consultation with a neurologist, but it may be appropriate to bypass local facilities that don't have the advanced X-ray guided techniques that can diagnose fully, and also "patch" a bleeding area.

I might argue that it's less a problem of "inferior goods", and more a problem of access to "standard goods". The access problem can be bad in a sparsely populated area, or in an underfinanced urban one.
--
Howard

*equal opportunity offense to both extremes*

Excelent ideas. At the moment as realistic as comprehensive peace in ME, but we should strive to achieve both in the longer term.

The normal metrics are longevity and infant mortality.

The outcomes of treatment in a particular condition cannot be a good comprehensive measure. Suppose that 10% of our heart attacks are untreated, but among the treated cases we do better. Or suppose that we heroically save lives of people who are in terminal stages of some diseases, thus boosting the "recovery rate" with negligible gains in longevity (and we screw up something else, so the balance is negative).

JPF, I think we have found a meeting of the minds!  Your point is brilliant as it stands:

." That is, there are no affordable substitues that will do just as well as the high-priced stuff (generic drugs are about the only exception I can think of.)  OK!  Here it is!!!!!!  You stumbled across it!  You want "affordable substitutes?"  How about affordable improvements?

You have hit on a huge aspect of universal health care:  Preventive Medicine. 

That is the substitute!  Monitoring people for blood pressure, mammograms, PAP smears, etc , and pre-emptively treating them is infinitely cheaper than the medical care for stroke, advanced breast cancer, or advanced cervical cancer.

The whole point is that society as a whole benefits from preventive medicine,  and preventive medicine, in order to be effective must be available to the entire population.  It is good for the quality of life of our entire population. 

Jan Knaus

I have a neighbor that stubbornly refuses to pay for medical insurance. One day he cut his leg pretty badly, it needed stiches. He walked into a clinic and asked how much it would cost to stich up his leg. The administrtors at the desk had no idea. They said he'd have to call the billing department the next day.

He was a mechanic. He told them that was criminal. He had a fee schedule displayed on the wall of his garage--by law--and he asked what kind of idiot would purchase services without any idea of the cost.

We're all idiots.

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I'm OK with preventative medicine, but I don't see it as a cure-all. It's pretyty much a fact of life that rather few of us will die suddenly and without previous illness. No matter how healthy we live, in the end we will suffer some slow degenerative disease in old age and run up huge healthcare bills. Those with healthy habits may postpone that for a decade or two, but in the end the decline comes for all of us. The real issue is figuring how to manage the costs of that decline, and of other catastrophic illnesses. That's where the lion's share of our healthcare spending goes.

There's a reasonable body of medical opinion that suggests a future where slow degeneration will not be the expectation, although total longevity may or may not be extended. Techniques for this sort of thing start with present methods of turning diseases once quickly fatal into relatively symptom-free, manageable, chronic diseases. This can be nuanced, depending on genetics and management. For example, both my father and I started showing hypertension in our early thirties. By the time he was in his late thirties, he was significantly limited by heart disease, and was dead at 42 in 1965. I had a first episode of unstable angina at 39, but had it treated aggressively with techniques not available to him, including newer drugs, angioplasty, and bypass. For a time, my heart function continued to decline, not in a terribly limiting way, but in the last 8 years or so, some secondary genetics kicked in and my heart self-repaired. I'm turning 58 in a few weeks, and, while I definitely can lose weight and exercise better, my heart is back to the edge of athletic conditioning.

Some things that may be too onerous now, such as extreme calorie reduction, may extend life but, at present, still depend on genetics. Apparently, I had genetics both for early onset of heart disease, but, as long as it was controlled, additional genetics for "self-bypass", or autocollateralization, where small blood vessels in the heart enlarge to take over the load of the blocked ones.

There are a class of interventions that are more than science fiction, in that we understand quite a bit about the mechanism, but not how to manage it. One very major breakthrough was the understanding that cells effectively programmed to die after a certain number of cell divisions, a process called apoptosis, which is regulated by p53 genes, also called telomeres. A cell starts off with certain number of telomeres, and, every time it divides, loses one.

Apoptosis, if you think about it, is a defense against too-rapid growth in cancer. The tumor cells are dividing too quickly, but they die off more quickly. If we can develop nanotechnology that examines individual cells, and, conceptually, if they turn out to be cancer-free, splice new telomeres back into the chromosomes. It should be obvious I'm simplifying a great deal, but this is one of the first theoretically sound approaches to actual life extension.

We aren't talking immortality, and we also aren't talking something that would be widely available at first. It's possible that this would do no more than keep older people youthful until a quick death.

To say that we have issues now with healthcare economics, the idea of true life extension, especially if available only to the wealthy, has policy implications that tend to go into the unimaginable. For one science fiction view that actually has had more accuracy than the author knew, see Robert Heinlein's Methuselah's Children.
--
Howard

*equal opportunity offense to both extremes*

The trouble is, of course, that exorbitant pricing of drugs by a Merck or Pfizer is not necessarily the best way to encourage small biotechs to develop revolutionary new platform drugs that must overcome superstitious dread and hostility at the FDA, if not outright corruption.

Why not? It seems that knowing you can accrue significant profits from drug discovery would be a huge incentive to develop new drugs.

1. Require the government and pharmaceutical companies negotiate prices for patented medications purchased for government programs and beneficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparancy we should make the negotiated prices public

While the prices may not be public, this is already done by the government. The VA has always had separate governmental pricing from the pharmaceutical and medical industry. Same is true for Medicare.

If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of pr oven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer

This would be excellent, especially if the FTC insisted that all the side effects with a greater than 1% incidence along with any major organ test changes have to come across the screen in the same size text as benefits and features of the drug. hahahaha..this should sufficiently scare the average consumer.

Retrieve the taxpayer’s contribution to drug development costs (approximately 20 billion a year to basic medical research) from patent holders and use these proceeds to defray pharmaceutical prices to consumers. This would also require the disclosure of the real development costs of pharmaceuticals.

How does this work? What is the source of  these tax contributions from the consumer? Pharmaceutical companies fund 90% of the R&D costs for new drug development. We can gauge the cost of development, by NIH, costs. Which  is typically funded with tax dollars vs. private industry.

Prohibit direct to consumer (DTC) advertising. In a 30 second ad full disclosure as outlined below is not possible. As a result patients do not fully understand the limits and costs of any given product. Few countries allow such advertising.

I agree. DTC advertising, results in patients pressuring doctors to prescribe medications which may be no more therapeutically effective, but which the mere suggestion of such in a TV ad gives hope to the patient and thus their demand. Physicians know if they do not prescribe it, the patient will simply go to another MD who will. The doctor does not want to lose the patient and will prescribe the drug, even if he thinks there will be no therapeutic gain. This is how Vioxx/Celebrex became such  blockbusters, despite not demonstrated to be anymore effective than other drugs on the market yet, it was a huge seller due to DTC advertising. Most physicians, know full well that the risks of new drugs are unknown and are far more reluctant to prescribe them, until the drug has established a safety profile in the public arena vs. clinical trials.

Require clinical studies include cost data as well as a measure of cost effectiveness (QALY-Quality adjusted life year or other) in the discussion of any phase II, III or IV study reporting positive results.

This would not benefit the consumer and would just add to the cost of development. In Phase II, you are primarily doing human dosingm excretion and the metabolism of the drug. Phase III trials are much larger patient populations where you are looking to establish efficacy. This type of QALY studies are primarily valuable during Phase IV, or basically post-marketing where you have treated a large enough patient population and have comparative data to determine the outcome of quality adjusted life year.

What would be much more useful, is for the drug to have to do a head-head, efficacy trial against the 'standard of care' drug to demonstrate therapeutic benefit, dosing and/or better side effect profile. Presently, efficacy trials are only done vs. placebo and comparative side effect profiles are done against 'well-established reference standards' which would be aspirin and indomethacin for NSAIDs.

Monitor the FDA approval process to be certain that generics come to market quickly on patent expiration.

Generic mfgrs do this already. The problem is that companies are able to get patent extensions. That is what holds up generics from coming to market.

The Canadian system controls patented drug prices by not allowing marketing unless the drug is priced right. A similar program could be instituted here to decrease our pricing to the level of other industrialized countries.

Canada does not bring out any new drugs or major medical advances, either. Restricting drugs on the basis of cost is not a good idea. I would prefer to see that drugs be restricted to market in terms of being a therapeutic advance, vs. all these 'me too' agents, which do not provide advances in treating a disease but allow mfgrs to make money simply because their drug can be taken 2X daily rather than 3-4X daily. A drug should not be brought to mkt to compete with another patented agent unless it provides a significantly better side effect profile or therapeutic advance.

The same process that the Canadian patent drug review board uses. If priced 10% over the comparator, the patent length would be decreased by a similar 10%–there are many ways such a link could be structured

This might be a good deterrent to 'me-too' agents. I would not support this for new therapeutic agents simply on the basis the mfgr's pricing. R&D costs do not shrink as time goes by, if anything they increase significantly..


Longevity and infant mortality are poor indicators of the quality of the health care system.

Many factors effect longevity that have nothing to do with the health care system. For example, we have more gang bangers killing each other over drug turf than other countries. That lowers longevity, but that says nothing about our health care system. Ditto our junk food consumption. Longevity among 70 yearolds might be a better guide as their survival is much more closely linked to the health care system. Infant mortality is dramatically effected by other issues as well.

Basing policy on the wrong metric is counterproductive.


The sons of the prophet are noble and bold,
and quite unaccustomed to fear.
But the bravest by far in the ranks of the Shah
was Abdul Abulbul Amir

We're all idiots.

 Speak for yourself, (LOL!)

Hey, the other aspect of the story about your neighbor is that there IS no one fee for any particular service.

The person on the next gurney with insurance has a different fee schedule than the person on the other one with Medicaid, and your friend with NO insurace pays the most, because he doesn't have an agreed-upon fee like the other payors do. 

Is this right?  No.  So why is it this way?  Because

1.  Congress is completely beholden to insurance and big pharma, AND

2. because Congress has such a good policy that they don't want to be included in a universal program that would include them with the great unwashed.

Jan Knaus

 Monitoring people for blood pressure, mammograms, PAP smears, etc , and pre-emptively treating them is infinitely cheaper than the medical care for stroke, advanced breast cancer, or advanced cervical cancer.

Yes. And this is also the answer to increased life expectancy. Who is going to push for this, though? Doctors make money because patients eat too much, smoke, and do not exercise.

The government contribution to drug research is, to a great extent, through direct grants to researchers. For example, Judah Folkman, one of the developers of anti-angiogenesis agents (Avastin) was supported by federal grants for 23 years before taking the drug private. This drug costs $50,000/year.

Another example is imatinib (Gleevec), a drug for chronic myelogenous leukemia. This drug is a wonderful advance, was funded by federal funds during the development stage. It was proven effective after one clinical trial and on the market almost immediately. There were minimal clinical trial costs for the company involved. The cost is in the range of $40,000/year.

The tax payer was a significant contributor to these drug's development. How many times should the taxpayer pay? It’s not as if the pharmaceutical companies are marginal enterprises. Patent law has been carefully crafted to maximize profits of the drug industry. During the patent protected period drug companies can and do charge whatever they wish for a product. The industry has enjoyed record profitability—one example is that in 2002, “the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).” (From Marcia Angell’s book, The Truth About Drug Companies)

In regard to generics, drug companies still game the system. One only has to look at the July 3 article by Mark Kaufman in the Washington Post which noted "Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition." Or this article from the Times (http://select.nytimes.com/2006/07/011nocera.html)

In regard to cost estimates of a clinical improvement (QALY). You are right these studies should be limited to stage III studies. Stage II are not comparison studies designed to document and compare efficacy. In my experience stage IV studies are frequently manipulated and of limited utility. The most outstanding example being stage IV studies of breast implants in which the drug company failed to follow-up on half the patients.

A rough estimate of cost benefit can be obtained simply and cheaply by estimating the cost of drug, ancillary expenses and add them up. A benefit that costs hundreds of thousands of dollars (see http://medicynic.com/?p=47 for an example) to achieve and does not prolong life should be a non starter. Requiring such estimates would have a moderating effect on pricing and also call the consumer's attention to the limited benefit of many new agents.

Educating the public about costs is key to controlling expenditures. Charging more than the median and average incomes, more than a new car or for that matter, over the life of a patient, more than his home for one drug is excessive and predatory on the part of the pharmaceutical industry. I do think it is a death tax.

In regard to the location of new drug development, guess what, many new agents are developed and initially marketed overseas.

Is this right?  No.  So why is it this way?  Because 1.  Congress is completely beholden to insurance and big pharma, AND . because Congress has such a good policy that they don't want to be included in a universal program that would include them with the great unwashed.

I certainly agree with 2.

I am not as certain about 1. I think a large part of this issue is that physicians have settled for allowing insurers to be the middle man when it comes to payment for svcs.  If more physicians stood up to insurers and simply took cash..that would alter the system significantly.

The incentive for physicians to do this is that they get to set their own prices, and not be dictated to by the insurers.

The downside is that they have to do the billing to patients, if they extend credit for svcs, rendered, which will entail collection costs as well, no doubt.

Additionally, patients are often locked up by employee plans as to which doctors they can see in a 'network'..limiting the available 'pool of patients' for the physician.

However, some MD's are now beginning to fight back. Pediatricians and psychiatrists for one.  Psychiatrists are finding that the 'insurers' are gypping them out of business by having patients put on Zoloft, Paxil,Seraquil, etc..rather than the patient receiving therapy. Those drugs do nothing but mask the symptoms without treating the underlying cause..since insurers do not recommend individual counseling therapy to treat the root cause of the anxiety, stress, depression etc. So, the patient is basically being put on drugs for a lifetime (which big pharma likes) and they have all the attendant side effects too..loss of libido, weight gain/loss, liver problems, diarrhea..etc.

Patients should fight back against insurers as well in terms of these 'networks' and 'participating providers' since it does not contribute to their overall health care, as physic ans are not required to remain participating providers nor on any network. Which means patients lose continuity of care, when the MD is no longer under a specific plan they are insured with. Worst of all, is that employers switch plans, so that patients are forced to start their care all over with new doctors in the 'new network' the employer switches too. Which means that the patient has no choice either over who they see for their health care.

This is particularly bad for patients with chronic conditions like  hypertension, diabetes and asthma, where the physcians want to do their own evaluations of the status and take the patient back to square one in terms of what is the most effective therapy. Which is medically sound for the patient as well as the MD in terms of liability. However, it is not good for patients who are doing well on their current plan..not to mention it can be expensive. However, it is less expensive than hospitalization.

This is one of the major problems and big contributing factors to the lack of quality of healthcare...the lack of continuity of care. You cannot see numerous physicians and expect to receive quality care. People need to have one primary care physician that they continue seeing for extended periods, since he is most likely to detect when your "normal" tests are abnormal "for you."

The lack of continuity of care basically forces a patient to maintain their own health records, and be diligent about what is a change in their 'norms' as well as to be their own monitor of ongoing problems and body system changes. The patient has to know their health condition very well or they will mistreated, undiagnosed and over or under medicated in 7 out of 10 cases.  This is particularly true for individuals who are forced to use mail order pharmacies and who are on multiply drugs. Often times patients receive subtherapeutic dosing but they are doing well so they do not complain as they are unaware they could be doing better.

Continuity of care, is critical for the tiered system of health care to be effective in America. Patients today, do not have one person monitoring their health, another noting symptom changes and the pharmacy monitoring drug therapy, when they go to multiple physic ans who likely have no clue what the other specialists are doing or what OTC meds the patient is taking. Patients tend to tell their pharmacists of more symptom changes than their physcians.

Patients and physicians, should be protesting about  how the insurers have decreased the quality of health care delivery and the accessibility to quality health care. 

What is clear is that ultimately, the fragmented for-profit nature of the health care system lies at the root of why the United States spends fifty percent more of our annual income on health care than the average European country (15% of GDP in the US vs. 10% of GDP in Europe) and yet health outcomes in the United States place it thirtieth in the world, behind Singapore, Chile, Costa Rica, Japan, and every Western European nation.

Hmmm, this is not at all clear from the article cited, even if fragmentation does result in higher costs. Decreasing fragmentation may lower overall heath costs but it does not correlate that it will result in an increased quality of healthcare for the consumer. Only that delivery costs will be lower.

What the USA spends on health care vs. other countries is not truly a relevant criteria in terms of health outcome. The reason we know this is because we are a capitalistic society and medical care is not at all delivered in a cost-effective manner. So, to somehow attempt to link link life expectancy and infant mortality is illogical. Particularly, as the American diet and lifestyle is one of the least healthy in terms of life expectancy. We are a nation of obese adults and children. That factor alone decreases life expectancy, without any costs of medical care. Additionally, a recent study showed that being overweight at 50 also decreases life expectancy. Life expectancy does not at all correlate with the cost of medical care.

Also since this study was of only white Americans it is truly irrelevant when America is almost 40% non-white. The only thing it really highlights is that white Americans have poor diets, are just obese and have even more unhealthy lifestyles than  people of color in third world countries

A recent Business Week profile (read the whole article at the link) of the Veterans Administration health system emphasized that an integrated health care system like the VA can accomplish savings that the rest of the balkanized for-profit health insurance system cannot.  

An integrated health care system would improve the overall delivery of health care. That does not mean it would change life expectancy, which is far more dependent on diet and lifestyle than delivery of health care. In short, no matter how cheap health care is, it would not necessarily be true that decrease costs would result in higher outcomes or improved life expectancy for the overall society.

To increase life expectancy for the overall society we need to change our diets and lifestyles. We need preventative medicine and accessible health care. These variables would significantly impact life expectancy and infant morbidity and mortality. All we have to do is look at pre-natal care programs to see what a reduction we ahve in terms of infant morbitidy and mortality to understand the impact of preventative care vs. the cost of health care.

I am not as certain about 1. I think a large part of this issue is that physicians have settled for allowing insurers to be the middle man when it comes to payment for svcs. If more physicians stood up to insurers and simply took cash..that would alter the system significantly.
The incentive for physicians to do this is that they get to set their own prices, and not be dictated to by the insurers.
The downside is that they have to do the billing to patients, if they extend credit for svcs, rendered, which will entail collection costs as well, no doubt.
There's another downside, which is quite addressable with political will. Benefits managers arguably define prices for wide area, and, through "most-favored-nation" clauses and market research, have fairly accurate information on what minimum prices the market will support. A certain number of providers leave practice, or join groups, etc., to deal with the lower margins and greater administrative costs -- while office practices may only belong to a few networks and have to comply with their procedures, hospitals often have to negotiate hundreds of reimbursement agreements.
Obviously, benefit managers have a major effect on a free market. This is especially true because they usually engage in the artificiality of price setting based on competing for employers. I call this artificial because the natural market process, recognizing health care cost is significantly inelastic, is between true provider and true consumer.
The Department of Justice, however, has warned providers that if they set prices, or even "collude" about whether professionals in an area can establish local standards about requiring cash, that said providers will be prosecuted for antitrust activity.

--
Howard

*equal opportunity offense to both extremes*

There's another downside, which is quite addressable with political will. Benefits managers arguably define prices for wide area, and, through "most-favored-nation" clauses and market research, have fairly accurate information on what minimum prices the market will support

Yes. But is this not a form of mkt collusion? Physicians can use this as a reference bar, but if you provide svcs. which deliver above the 'standard' outcomes...is it OK to charge more?

 A certain number of providers leave practice, or join groups, etc., to deal with the lower margins and greater administrative costs -

Yes. They also leave those netowrks once they establish a base of patients. Which is how many physcisans today, establish a primary practice.

while office practices may only belong to a few networks and have to comply with their procedures, hospitals often have to negotiate hundreds of reimbursement agreements.

Hospital reimbursement is separate from a private physcisna and not at all the same.

The Department of Justice, however, has warned providers that if they set prices, or even "collude" about whether professionals in an area can establish local standards about requiring cash, that said providers will be prosecuted for antitrust activity.

Physicians need not collude to set fair market value. That is not anti trust.

Other than for purely elective services such as cosmetic surgery, it's rather rare for rates to be set based on outcomes. The more likely event is that a provider with excellent outcomes will have increasingly long queues, and some patients will go elsewhere. There are, of course, secondary complexities. In Virginia, National Orthopedic & Rehabilitation Hospital literally closed because the administration wouldn't approve a more expensive hip prosthesis preferred by the guru of hip orthopedists. Since he headed the largest orthopedic group operating at that hospital -- literally connected to it -- when the group all transferred their surgeries elsewhere, the hospital was no longer a going concern.

Unfortunately, the article discussing the Antitrust Division warning is in a hard copy version of the Journal of the AMA somewhere in storage, so I can't provide a link. A very, very wide interpretation of collusion was described.

I'm not sure what you mean by hospital reimbursement being different than private practitioners, having built information systems for both, assuming we are talking fee-for-service rather than capitated plans. The individual or institutional provider submits a claim for certain CPT-coded services, along with an ICD or DSM diagnosis code, and receives, assuming approval, the reimbursement negotiated with the benefits manager. Due to the sheer workload of negotiation, solo or small practitioners rarely negotiate with more than a few providers. I've worked on hospital systems that had well over 400 benefit manager contracts, often with options under each for particular combinations of copays, etc.


--
Howard

*equal opportunity offense to both extremes*

I must say, I'm somewhat horrified by this thread. I'm afraid I don't have any sort of meaningful contribution, except to say that in terms of health care and healthy lifestyle, it must suck to be American.

I do not see the necessity for it. The discussion has become technical, as much for the purpose of concealment and protecting ideologies, as for the purpose of clarity.

You're probably worried we will find out your ultimate secret of longevity: poutine is actually healthy.

In this context, yes, it sucks. Seriously, among my Canadian friends, care does seem to be better in Ontario than BC.

My one personal experience, in Toronto, first taught me never to eat bad sushi before any journey, especially across a border. A hotel that gives personal attention when a guest is sick, such as the Holiday Inn on King (very high end for a Holiday Inn), deserves special attention, beginning when the switchboard figured out my need for help, and got the ambulance. The paramedics were both pleasant and competent.

I knew I was truly in good hands at Toronto General's ER, when I saw my primary nurse, in addition to hospital ID, was wearing a Starfleet Medical badge. For those not up on Star Trek trivia, there are many inside jokes that can be seen on the set, but not on low-resolution TV. On the New Generation, the bottom bar graph on the medical bed is actually labeled "Medical Insurance Remaining".

Scary.
--
Howard

*equal opportunity offense to both extremes*

Quality of care varies across the country. Ontario, the richest province, and Toronto, the biggest city do best.

On the other hand, I hear that its pretty terrible in Alberta. But that's ideological. The poorer regions, like the maritimes or northern manitoba, are fairly low end, but still manage to do okay.

I'd like to make a pertinent observation in terms of health care and life spans...

One of the things that makes a difference to medical outcomes, and to overall health and longevity, is the proximate willingness to see a physician.

The United States, with its morass of private care systems, dubious insurance plans, and uninsured, strikes me as fairly hostile to the concept of early entry.

That is, if a person gets sick, most times, they're going to wait a while before seeing a physician, for no other reason than that it is directly or indirectly costly. After all, if its nothing, then you haven't used up your medical insurance chit, or whatever, you haven't risked the family savings...

The trouble is that the longer you wait on illnesses or health problems, the worse, if genuine, it gets. The more resistant it is to treatment, the more protracted and difficult the treatment, and the greater the chance of long term damage.

The result may be a general degradation of the health of the population and the lowered life expectancy.

Up here in Canada, I've heard physicians say that their time is cluttered up by too many people with nothing much wrong with them.

It makes me want to punch physicians in a nose. My father had a lymphatic cancer growth on his neck the size of a golfball before he was willing to see a physician. Most people would prefer to ignore sickness and hope it gets better. The truth is that patients are not qualified to diagnose whether an ailment is trivial or not. That's up to the physician.

So, the Canadian complaint really means that people are going to physicians in the early stages, when something can be handled or dismissed as trivial, rather than the late stages, when it can all too often be fatal or cause long term damage.

I have extended family in Kamloops, BC, which, while its medical facilities are improving, certainly aren't Vancouver or Toronto. These people have some real but obscure ailments, and, even in Canada, I've had to help them game the system and get more intensive care. Usually, this takes the form of getting permission from the patient, and then faxing what read like consultant reports, gently chiding, in jargon, to go take a second look at something they aren't seeing -- perhaps because I can spend two hours on the phone with my "virtual daughter", who is herself fairly medically knowledgeable, getting an extremely detailed history.

No, I'm not a physician; I just play one in medical software. It was amusing last night -- I'm staying with friends at present, and had some intense chest pain, which I really knew was a muscle pull and not cardiac. One of my hosts is an emergency physician, and I had to convince his wife, who is a medical information systems person, that we really didn't need to wake him up. In this case, I really did know how to diagnose -- but it's always a question, including for the best physicians themselves, knowing when to call for help.

Canadian facilities seem to manage a certain calm less typical of US hospitals. My "daughter" returned to the ER following abdominal surgery, and it seemed so Canadian when she asked her husband to go to the nurse and say that if there were no objections, she needed to go to the head of the line, as her intestines were slipping out. Everyone agreed, very calmly and supportively.

--
Howard

*equal opportunity offense to both extremes*

I suspect that under any imagineable health care system, people who live in the boonies will get poorer care than those who live in major cities

I am rather optimistic about life extension technologies over the long haul (though probably not soon enough to benefit most of us). But we aren't going to become immortal, let alone invulnerable, and even if our life span doubles, once the limits are reached the last six or so months will still be hell.
Of course we may have an understanding by then that when decline comes we limit what we spend on keeping people alive: palliative care certainly, but nothing else.

The limits of life extension were also addressed by Heinlein, although in the novel Methuselah's Children, the long-lived (clandestine) subpopulation simply had good genetics. Their foundation's medical staff constantly searched for true longevity techniques, but, at the time the novel starts, they essentially are methods to delay senescence. A member of the group would usually elect euthanasia once the diagnosis was firm.

Senescence delay is not an implausible possibility, and, if when the last weeks or months come, the decline is very rough, I wonder how society (and religion) will deal with it. Could it be a novel situation where only the wealthy have the luxury of quick death?

--
Howard

*equal opportunity offense to both extremes*

Consider the environmental risks of an especially polluted inner city versus farmland or resorts, and the benefits of care get complex. In many cases, people in more remote areas have healthier lifestyles.

Of course, this isn't comforting when someone has a stroke or heart attack, and is many hours by road and still significant time by air to a facility that can do disease-modifying interventions. Oregon, especially, has met some of these challenges with greater paramedic autonomy than most states. It's not unreasonable for paramedics, who also can send an ECG to a base hospital, to start clot-dissolving drugs (about $3000 per dose, but effective), for heart attack.

Developing stroke is a tougher call. There's both less time to act (3 hours preferred and 6 hours outside maximum), and you could indeed start the drugs based on symptoms, and the probability that a clot is the cause. If it's the smaller proportion, with somewhat different but sometimes subtly different symptoms, with a hemorrhage in their brain, the thrombolytics will kill them. Only advanced neuroradiology can make a firm diagnosis and, when the capability is there, stop the bleeding without surgery.

--
Howard

*equal opportunity offense to both extremes*

Re: Could it be a novel situation where only the wealthy have the luxury of quick death?

Unless assisted suicide is somehow limited to just the wealthy, why would they die any easier than anyone else? A case could be made that the poor would have "quicker" deaths since they would have less accesss to life extension technology and would perish (albeit younger) still from simpler, quicker causes.

A scary thought: an "old" population would be a very conservative population, not just politically, but in every way. What happens if culture, science, technology etc. ends up just stagnating because no one is very innovative any longer?

Unless assisted suicide is somehow limited to just the wealthy, why would they die any easier than anyone else?
I'm thinking of just such a limitation. By way of analogy, in some states during the mid-sixties, safe and legal abortion, without a clear physical disease, was not readily available -- except if you were wealthy enough to get high-end psychiatrists, possibly involving a hospitalization at a very pleasant private facility, to certify that it created a risk of suicide or severe mental disease.
A case could be made that the poor would have "quicker" deaths since they would have less accesss to life extension technology and would perish (albeit younger) still from simpler, quicker causes.
I'm thinking of common causes of death in undertreated populations. Progressive congestive heart failure. End-stage renal disease without dialysis or transplantation. Metastatic cancer caught too late for early intervention. Chronic obstructive pulmonary disease.
None are fast or gentle ways to go. Death by respiratory failure probably scares me the most, although watching my mother die slowly from breast metastases to bone and brain.
The latter wasn't, incidentally, a lack of resources. She had been transferred to a VA hospital (mid-seventies) who would not honor my durable power of attorney, DNAR signed by the patient, etc. Her heart was strong; they did three full codes, smashing brittle ribs every time. I had to fight all the way to the top level in DC to get the actual autopsy report -- and I had given autopsy permission conditional on my receiving that report.
She had been in a community hospital previously, and had a drug reaction which would have produced a gentle death. Unfortunately, the staff wouldn't tell her that "the treatment to build you up, dear" was the only thing keeping her alive.
She was still rational, and it fell to me to give her the true options. There was one remaining treatment, with about a 30% chance of getting some life extension. If she didn't have the drug reaction (hypercalcemia) treated, she would grow more and more sleepy, and then just not wake up. I told her that I would support either choice, but it was her right to make the decision.
This is the kind of situation that I can see going very bad in a limited care situation, with no medically knowledgeable and legally authorized advocate. I sometimes ask myself if I made the right decision to tell her that her refusal of the "build you up" would have specific consequences, with the hindsight of knowing how bad a death she had.
Life gets complex; I made some seemingly rational decisions to continue treatment and defer euthanasia of some dearly loved cats. In one case, I'm pretty sure I made the right decision to support her for two years, as she was debilitated but clearly happy. At the very end, the roads were impassible, and there was a point where I would have euthanized her -- but I simply didn't have the appropriate drugs.

--
Howard

*equal opportunity offense to both extremes*

For example, Judah Folkman, one of the developers of anti-angiogenesis agents (Avastin) was supported by federal grants for 23 years before taking the drug private. This drug costs $50,000/year.Another example is imatinib (Gleevec), a drug for chronic myelogenous leukemia. This drug is a wonderful advance, was funded by federal funds during the development stage. It was proven effective after one clinical trial and on the market almost immediately. There were minimal clinical trial costs for the company involved. The cost is in the range of $40,000/year.....The tax payer was a significant contributor to these drug's development. How many times should the taxpayer pay?

OK, I see the point you are making.  Avastin has not been successful in the mktplace. Many patients bleed to death. Great therapeutic strategy but not so great intervention clinically.

Basically, you are talking about  or referring to pre-clinical costs or drug discovery vs. cliniical trials to test the drugs in humans for safety and dosing as well as metabolism and side effects. Those tests are considerably greater in costs and moreover take significantly longer.

In general, it takes 12-15 years to bring a new drug to market, preclinical amounts to about 3 years or roughly one-fourth of the expenditures to bring a drug to mkt, with pre-clinical being the least expensive.

Patent law has been carefully crafted to maximize profits of the drug industry. During the patent protected period drug companies can and do charge whatever they wish for a product.

And what is the incentive to bring a drug to mkt without this patent protection?. Given the tremendous cost, of roughly 802M to bring one pdct to mkt how is this not OK. Let's not forget that only about 1 in 5K compounds are brought to mkt successfully so there is tremendous investment, that needs to be recouped, following the success of efficacy trials and mkt approval. If a mfgr cannot hope to profit from his risk what incentive is there to take the risks to succeed? A 20 year patent does not seem to be excessive for a 15 year investment with a significant number of failures along the way. Not to mention the costs of those failures.

The industry has enjoyed record profitability—one example is that in 2002, “the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).” (From Marcia Angell’s book, The Truth About Drug Companies)..... Charging more than the median and average incomes, more than a new car or for that matter, over the life of a patient, more than his home for one drug is excessive and predatory on the part of the pharmaceutical industry

Everything in life is relative. General Motors profits for one year alone is more than the ENTIRE pharmaceutical industry combined. No one complains about the cost of their car, yet somehow folks think that drugs should not cost? The average consumer spends more on their car payment and or mortgage than they do for prescription drugs. Average incomes do not dictate price in a capitalistic society. Surely, the profits of the oil industry and housing should be protested long before the costs of pharmaceutical. Afterall, patients claim they want to be healthy and they do not necessarily need a car or big house, but generally will spend for more far those than they do for their prescription meds without nearly the complaints. Despite the ROI being significantly greater.

And just to  be really controversial, why should individuals who have poor diet, behavioral and  deleterious lifestyle habits think they should not have to pay to treat their health problems.? People who drink and drive have greater costs in terms of societal risks so why not those with poor dietary habits, exercise routines and sedantary lifestyles? While diseases can have a genetic component, just because a person has a genetic predisposition does not mean they will get the disease...that varies depending on their lifestyle.

In regard to the location of new drug development, guess what, many new agents are developed and initially marketed overseas

Developing drugs overseas, does not alter the time to market, which is the big factor in drug development costs. HIV drugs were rushed to mkt just like cancer agents are..and both of these therapeutic groups have the most toxic agents on the mkt. i.e. the drugs make you sicker than the disease. So, yes we can decrease drug development costs, but at significant risks to the consumer.

 HIV and cancer patients are often far more ill from their medication than they are from the disease itself. Worst of all, the drugs have not been shown to significantly decrease the morbidity and mortality from the disease  itself alone. In fact, what you have in both of these diseases are surrogate tests and arbitrary markers of 'remission' which generally are punctuated with cycles or 'disease exacerbation' without any true amelioration of the disease.

As with most things in life, you get what you pay for. Faster time to market, shorter length of clinical trials and smaller clinical trials ...simply means more toxic drugs and larger numbers of patients who are nothing but 'free market' guinea pigs for 'therapeutically approved'  toxic agents. Drugs and cars are alike you get what you pay for and sometimes you still wind up with a lemon.

P.S. no, I do not believe that controversial stuff I said, but it makes  great dialogue...lol

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