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The annual oncology meetings (American Society of Clinical Oncology–ASCO) are on and we are destined, the next few days, to be bombarded with reports extolling the virtue of various interventions. There is real progress being made, new approaches based on blocking cell receptors, anti-angiogenic strategies and new combinations of various cyto-toxic agents.

The issue in not whether there is progress but how much progress and at what financial cost. The pharmaceutical patent monopoly allows companies to charge whatever they wish for new agents, no matter how marginal the results. The cost is based not on the cost of research or production or even the amount spent on promotion (which exceeds the costs of research by a wide margin).

Rather the pharmaceutical companies realize patients with cancer are not rational consumers who have the luxury of comparing products (approaches) and choosing the best value. Rather they are desperate for anything that might help their situation. I’ve been in the position of informing patients they have incurable disease and that the best we can do is offer medications that offer a chance of amelioration for a time–often as little as 10% response rate and as little as a month or two median improvement in survival. Patients more often than not choose to be treated, even though the costs are extreme.

There are numerous examples but take today’s news about a survival benefit in liver cancer with the use of a drug Nexavar . Nexavar is a multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases. These are found in both the tumor cells and blood vessels so the action sites are multiple.

Reuters reported from the ASCO meeting:

An experimental pill for advanced liver cancer helped patients live about three months, or 44 percent, longer than those on a placebo, according to a study released on Monday.

The trial found the drug Nexavar, by German drug maker Bayer AG (BAYG.DE: Quote, Profile, Research and its U.S. partner Onyx Pharmaceuticals (ONXX.O: Quote, Profile, Research, extended survival to 10.7 months, compared with 7.9 months for those on a placebo.

The drug was previously reported to be active against kidney cancer. In that tumor progress was delayed (“growth slowed”) for 4 months.

Last year Forbes noted:

“Onyx’s announcement that Nexavar will be priced at $4,333 a month, above the firm’s estimate of $3,200 and a Street consensus of $3,000, the financial analyst said in a report issued Wednesday.”

Also from the Forbes article this analysis: “We believe the drug should have limited exposure to price sensitivity, since Medicare Part D insulates Medicare patients from the cost of highly expensive drugs,” said the research analyst. “Private insurers are likely to look favorably on this drug as well, especially when compared to potentially toxic competitors with high treatment-associated costs,”

It’s wonderful that there is progress, but can we as a society afford the price? We need to revisit patents, the issue of responsible pricing and the non-negotiation policy of Medicare Part D–most of these patients are over 65 years of age.

The Daily Kos has this interesting post.

It’s similar to what’s happened in the media where the corporate owner’s interests affect the flow of information.

This is not all-inclusive but gives the sense of the pharmaceutical industry’s prime reason for being–making money.

10. Charging $100/pill for anti nausea medication (Emend). I have had patients tell me they would rather throw up than pay an exorbitant price for this type medication. There is something surreal about this pricing.

9. Aggressively marketing “new” patented drugs that have no additional benefit over previously developed and now generic medications. Prime example of this is Nexium a drug with no additional benefit over omeprazole (generic prilosec). Ironically Nexium is made and marketed by the same manufacturer as the generic. Why pay less when you can get the new “purple pill.”

8. Aggressively marketing drugs based on flimsy evidence: The recent findings that Aranesp and Epogen have serious side-effects and limited benefit (10 billion in sales/year) is the tip of the ice-berg. Other drugs that have been inadequately studied and found later to have marginal benefit and/or serious side-effects include estrogen, Oxycontin, and a number of anti-depressants. If one goes back in time there are many more examples.

7. Pricing to maximize profit–the name of the game: This sounds like good capitalistic policy but doesn’t it seem a bit excessive when people can’t afford a medication and suffer. Today many new drugs cost more each year than the median and average incomes in our country? Most important is the fact that pricing does not reflect the actual cost of development (much of which is from tax supported research). Our patent system actually protects these monopolists and assures that our pharmaceutical prices are significantly higher than anyplace else in the world. We won’t even allow the government to negotiate prices for the Medicare program–PHARMA strongly lobbies against such provisions. .

6. Paying physicians various stipends and fees with the result that they prescribe the company’s products more frequently than those who don’t receive these payments. The payment may be a subsidy for seminars, research projects, or whatever pretext the drug company can devise. The end result is a conflict of interest.

5. Paying researchers. This is particularly pernicious as the researcher (at universities, cancer centers and in private practice) rarely disclose the funding they are receiving from drug companies to enroll patients in research studies. The question is does payment affect results, their interpretation, patient selection or any number of potentially confounding variables.

4. Having FDA consultants on their payroll. The consultant then judges whether the medication is worthy of FDA approval. It’s hard to prove whether there is actual bias in these consultants’ behavior, but the appearance is damning. Disclosure of the relationship is not enough to eliminate the appearance of a conflict of interest.

3. Direct marketing that overemphasizes (or misstates) benefits while deemphasizing risks. You can refer back to the Epogen and Aranesp ads for verification. Direct marketing advertisement also never mention the cost of the drug. In addition, it is a fact that PHARMA spends more on drug marketing than research and guess who gets to pay?

2. The manufacturers of OxyContin (Perdue Pharma) for misrepresenting the addictive potential of their drug Oxycontin. At one point, they also recommended off label dosing of every 8 hours rather than the approved 12 hours. We are talking billions in profits for this drug. It appears with this manufacturer that anything that will maximize profits is fair game.

1. Not adequately cutting the cost of drugs to impoverished AIDS victims and blocking the use of cheaper generics whenever possible in third world locations. Many of these poor countries have health budgets of less than $25/person/year. The drug companies still want to charge in the range of $100-$1000/year for their anti-AIDS drugs and oppose the use of, and marketing of, generics that cost a fraction of the branded drugs.

People are dying while the drug companies are fiddling–not a pretty picture of humanity in the 21st century.

Provenge is a very iffy drug. The FDA is doing due diligence with it and is delaying it’s release on the market–There appears little value in this drug as noted below.

Tested against a placebo, Provenge, a prostate cancer vaccine manufactured by Dendreon, showed a survival benefit of about 4 months–barely statistically significant, given that the study included just 127 patients. Another study showed a survival benefit of 3.3 months, not statistically significant.

The vaccine was not tested against the effective chemotherapy for prostate cancer, taxotere, so we don’t know if it is more effective. It was not tested in patients who already received taxotere, so we don’t know if the effect of these agents will be additive.

For this we will pay an estimated, by financial companies, (I haven’t found a retail price yet) $30,000/year or more. Is it worth it? Who knows, the data is inadequate to reach a reasoned determination..

For the drug developer a real study of efficacy might be embarrassing. Thus they test against no treatment in small numbers and hope for at least an ambiguous result.

Millions of dollars in rebates from drug companies to doctors for the use of Aranesp and Epogen are reported in the Times today.

From Marketwatch–“Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies, but companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price, the Times reported.”

Adding insult to injury the drugs have been found to have unexpected untoward effects:

From the Times–“Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.”

These drugs account for 10 billion dollars a year in medical expenditures and have no effect on the quality of life or survival. It’s not difficult to imagine how this could happen!

It’s interesting to see a lining up of interests behind some type of health care reform. It’s amazing that it took so long for the business community to realize the need for a better way to finance care. This is another, but positive, effect of the “global marketplace.” I’m not partial to Schwarzenegger’s solution, it seems to advocate a jury-rigged Rube-Goldbergian (I’m dating myself) system of of financing care and little to improve efficiency.

The facts are that we already pay more than enough for health care for all and we need to do more than simply pay the asking price. Like purchasing a car we should look into costs and work to find the best price. This means eliminating administrative duplication; negotiating, negotiating, negotiating; tweaking the patent system to reward responsible patent holders and penalize those that gouge the consumer.

This from the National Coalition for Health Care:

“In 2005 (the latest year data are available), total national health expenditures rose 6.9 percent — two times the rate of inflation (1). Total spending was $2 TRILLION in 2005, or $6,700 per person (1). Total health care spending represented 16 percent of the gross domestic product (GDP).

U.S. health care spending is expected to increase at similar levels for the next decade reaching $4 TRILLION in 2015, or 20 percent of GDP (2).

In 2006, employer health insurance premiums increased by 7.7 percent – two times the rate of inflation. The annual premium for an employer health plan covering a family of four averaged nearly $11,500. The annual premium for single coverage averaged over $4,200 (3).

Experts agree that our health care system is riddled with inefficiencies, excessive administrative expenses, inflated prices, poor management, and inappropriate care, waste and fraud. These problems significantly increase the cost of medical care and health insurance for employers and workers and affect the security of families.”

Whether the flat earth people will have the sense and strength to alter our flawed system remains to be seen–but the pressure is building.

The college loan scandal continues. Not surprisingly it is not a new issue. Unfettered capitalism has a nasty tendency to push the limits and require some type of regulation. The Clinton administration proposed controls but Bush and company rejected them and allowed the current fiasco to develop.

From the Post:

“The abandonment of the 2001 proposal underscores what some consumer advocates and Democratic lawmakers believe is lax federal oversight of the financial aid system by a department they say is too cozy with the industry.”

“More than a dozen senior department officials either previously worked in the student loan business or found high-paying jobs in the sector after they left the agency.”

“The Department of Education has been run as a wholly owned subsidiary of the loan industry under this administration,”

Sound familiar? You could replace the Department of Education with the FDA or for that matter the Department of Defense and the financial aid system with the pharmaceutical industry or military expenditures and still make perfect sense.

Will we ever learn?

I’m stuck on this issue because it’s so pervasive and there has been a number of media and medical studies recently published that show the inappropriate relationship between physicians and drug companies.

The following is from the Washington Post article cited above:

“A quarter receive honoraria or some form of payment for their services, and that was much higher than we expected.”

“Drug companies also purchase prescription records from pharmacies and, with the help of an American Medical Association database, identify individual physicians’ prescribing patterns and rank doctors based on how many prescriptions they write, the authors wrote.

The tactics work. Another study in PLoS Medicine last week found that visits by detailers prompted nearly half of 97 physicians to increase prescriptions of gabapentin, a drug approved to treat seizures.”

It’s fascinating to watch the pie of health care expenditures enlarge and observe the various players working to get a bigger slice. Drug companies are really amazing at this, charging confiscatory prices (as much as $30,000-$60,000/Year) for new drugs and mobilizing an amazingly effective sales force.

Physicians seem to play the mundane role of tools in the game. Finding their percent share of the pie, represented as fees for service, declining, they work on other sources of funding and sell their services to PHARMA. Not an edifying picture of the profession.

The New England Journal of Medicine has an article this week on the relationship between PHARMA (the drug industry) and physicians. The article notes (its available on-line):

” Most physicians (94%) reported some type of relationship with the pharmaceutical industry, and most of these relationships involved receiving food in the workplace (83%) or receiving drug samples (78%). More than one third of the respondents (35%) received reimbursement for costs associated with professional meetings or continuing medical education, and more than one quarter (28%) received payments for consulting, giving lectures, or enrolling patients in trials. Cardiologists were more than twice as likely as family practitioners to receive payments. Family practitioners met more frequently with industry representatives than did physicians in other specialties, and physicians in solo, two-person, or group practices met more frequently with industry representatives than did physicians practicing in hospitals and clinics.^“

These companies don’t give away money for nothing.

I see parallels between the student loan scandal and standard practice in medical office.

“numerous college aid offices have been caught conspiring with lenders to carve out sweetheart deals that benefit everybody but the students

The shady practices include fees to colleges to put lenders on their “preferred” lists; trips and other perks for financial aid officers; and valuable stock benefits for college aid directors.”

In medicine, physicians and researchers receive fees, trips, consultant contracts, salaries, stock benefits and other gifts from drug companies and other vendors. These gifts seem designed to influence the physician’s choice of treatment or procedure. If you will, the company wants it’s drug on the physician’s “preferred” list.

While it’s not clear how effectively these emollients subvert physician’s decisions, the companies continue to spend billions of dollars on this type marketing.   There is, as in the student loan scandal, the damning appearance of a conflict of interest .