For over a year now, regulators have been looking into suggestions that the EPO drugs (Aranesp, Epogen and Procrit), might increase the risk of death and fuel the growth of tumors. But much of that evidence comes from studies in which patients were treated more aggressively than the drugs' labels recommend.

The FDA has said there is now "mounting evidence" of documented effects on survival, tumor progression and thrombotic events which require a reassessment of the net benefit of this class of drugs.

At the 12th annual NCCN conference, an executive with United Health Group, pointed out that in reviewing records of patients who were prescribed the drugs, 44% of those patients had blood work-ups that would indicate they were not even anemic.

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.

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.

Amazing how they can apply differing standards for proof or benefit when profit is involved! The profit motive did influence some doctors' decisions.

"It's clear that these drugs were overused because sales drop so dramatically in the past year without seeing reports of people dying in the streets," said Dr. Charles Bennett, a professor at Northwestern University, who authored the most recent analysis of anemia drug risks.

Until this revelation, the drugs had a combined sales of over $6 billion a year. After this issue had started to be reported, U.S. Oncology took an 8-10 million dollar hit in its first-quarter SEC report last year, including reduced pre-tax income due to lower use of anemia drugs.

The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for.

It's still a chemotherapy 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.

When are they going to take physicians out of the retail pharmacy business and force them to be doctors again!!!

Amen, Greg.

I wonder if someone can clarify the law regarding former officials lobbying on behalf of comapanies on "particular matters" in which they had participated "substantially," etc.

There appears to be a lot of wiggle room here. During the time that Dan Troy was Chief Counsel, he routed all warning letters through the OCC. As is well known, he has a much longer history - before and since - battling DDMAC.

Given his involvement in so many "particular matters" - that is, virtually all warning letters from 2001-04 - it would seem that his lobbying efforts would be severely curtailed indeed.

Am I missing points somewhere here? Thanks for any clarification.

Whatever was in place was pretty useless, as we know how fast and furious the door swings between government and business.

Back in 2004, a Denver Post analysis reported that Bush installed more than 100 top officials who were once lobbyists, attorneys or spokespeople for the industries they oversee. Daniel E. Troy was one of those more than 100 high-level officials who helped govern industries they once represented.

Troy, a powerful Bush administration lawyer made an unprecedented offer to drug companies, one likely to protect their profits and potentially hurt consumers. Then, a lead counsel for the FDA, after his role representing major U.S. pharmaceutical firms, he extended the government's help in torpedoing certain lawsuits. Among Troy's targets: claims that medications caused devastating and unexpected side effects.

Those former industry advocates have helped their agencies write, shape or push for policy shifts that benefit their former industries. They knew which changes to make because they had pushed for them as industry advocates.

Bush's political appointees made or oversaw profound changes affecting drug laws, food policies, land use, clean-air regulations and many other key issues.

Governement watchdog groups called it a disturbing trend. Government ethics standards were part of the problem because they didn't fully address the kind of issues that now permeate Washington. The rules focused mainly on direct financial conflists, but more nuanced conflicts were not addressed.

There were so many ways around, over and under these ethics bans, they virtually never worked. The lobbyists-turned-policymakers contolled or influenced health care, food safety, land use, the environment and other issues touched by government.

A related summary of recently GAO report. Of course, it was in 2002 that Dan T. effectively gutted the warning letter process by routing them all through his office, as summarized in paragraph 3.

GAO Criticizes FDA Regulatory Letters on Violative DTC Ads

The FDA continues to be slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer (DTC) advertising rules, according to a report by the Government Accountability Office (GAO).

Last year, the agency took an average of six months to issue regulatory letters citing violative DTC materials, Marcia Crosse, head of the GAO’s healthcare division, told a House Oversight and Investigations Subcommittee last week. In one case, the agency took more than three years to issue a regulatory letter, she said.

Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review — a policy for which there was no apparent need — it took less than a month to send such letters, Crosse said.

The FDA has not improved since a 2006 GAO report found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter,” according to the GAO report accompanying Crosse’s testimony. “In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”

Moreover, only two regulatory letters on DTC advertising went out in 2007 — one warning letter and one untitled letter — compared with 15–25 regulatory letters each year between 1997–2001, before the legal review policy. Meanwhile, the FDA “has received a steadily increasing number of advertising materials directed to consumers,” the GAO report said — approximately 6,000 in 1999 as compared with 21,000 in 2007.

The GAO report can be viewed at www.gao.gov/new.items/d08758t.pdf.

And this discussion is why I read GoozNews. So many well informed, knowledgable people who present their positions on the basis of information and fact. Thank you all.