Monthly Archives: May 2007

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?