FDA Strengthens Warning on Drugs prescribed for Anemia in Cancer Patients

The recent FDA warning seems to have caused some confusion with kidney patients and doctors, so much so that the Renal Physicians Association (RPA) has urged caution to physicians when changing current regimens of patients and that some parts of the warning do not apply to all patients.
Here is a link to [URL="http://www.renalmd.org/downloads/RPA_Guidance_NephrologyCareProviders.pdf"]Renal Physicians Association (RPA) guideline for physicians[/URL]. It is the advisory for nephrologists so it may be a little technical.
Here is another link on the [URL="http://www.spiritindia.com/health-care-news-articles-7409.html"]story about the RPA guidance story[/URL].

The New York Times article states that the drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug.

[url]http://query.nytimes.com/gst/fullpage.html?sec=health&res=9C06EEDB1331F933A2575 0C0A9619C8B63[/url]

According to Dr. John Glaspy, director of UCLA's Outpatient Oncology Clinic, one complicating factor, experts say, is that oncologists make significant revenue buying cancer drugs from manufacturers and charging patients a higher price for receiving the drugs in their offices. That profit motive could influence some doctors' decisions. However, patients with anemia, which can cause sluggishness in its early stages and can be fatal in advanced phases, can get blood transfusions, typically every few weeks, instead of using EPO.

Len Lichtenfeld, deputy chief medical officer for the Atlanta-based American Cancer Society, told United Press International, "Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs." A six-month course of treatment can cost more than $10,000 per patient.

In panel discussion that highlighted the 12th annual conference of the National Comprehensive Cancer Network, Lee Newcomer, former chief medical officer and currently an executive with Minneapolis-based United Health Group, pointed out that in reviewing records of patients who were prescribed the drug erythropoietin, said that 44% of those patients had blood work-ups that would indicate they were not anemic.

U.S. Oncology takes a hit! Reports first-quarter net loss.

U.S. Oncology said a number of factors impacted the results, including reduced pre-tax income due to lower use of certain supportive care drugs used to treat cancer-induced anemia: and the discontinuation of the Medicare Demonstration Project.

[url]http://www.bizjournals.com/houston/stories/2007/04/30/daily82.html?from_rss=1[/url]

The Senate Finance Committee Chairman found that the value of the approximately $300 million-a-year Medicare Demonstration Project to report on a patient's level of nausea, vomiting, pain and fatigue was for nothing.

CMS paid chemotherapy providers $130 per report, per infusional-chemotherapy recipient, on a patient's level of nausea, vomiting, pain and fatigue. However, HHS' inspector general's office found these providers were being paid an extra $130 to simply forward the data that was already collected.

A continuance of the Medicare Demonstration Project would have exacerbated existing economic and clinical problems instead of resolving them by increasing the temptations for physicians to overuse injectable drugs and promise to aggravate the ecnomic problems Congress attempted to fix with the new Medicare law.

U.S. Oncology Under the Gun

U.S. Oncology reports two seeming unrelated bits in their latest SEC Form 10-K. One note say cancer patients are suddenly using a lot less anemia drugs, and as a result U.S. Oncology will bank $8-10 million a year less than expected. The second note says that in 2005 the company was subpoenaed by the U.S. Department of Justice about contracts and relationships with pharmaceutical companies.

Coincidence?

[url]http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-03-2007/0004579964&EDATE[/url]

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.

It's still your mother's chemotherapy drug concession. Although the new Medicare bill tried to curtail the drug concession, private insurers still go along with it. What needs to be done is to remove the profit incentive from the choice of drug treatments. Let's take physicians out of the retail pharmacy business and let them be doctors again!!!