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PHARMA/POLICY/POLITICS: November comes after September

Interesting article in the WaPo about the impact of the donut hole in Part D on the Senior vote. I think it will matter, it will hurt the Republicans and the signs seems to be point that way in one House race in Florida. Of course whether it will matter enough to push the House over to the Democrats is another matter. But the most interesting stat in the article is buried on the second page.

Perhaps playing in Klein’s benefit: More seniors are finding themselves
in the doughnut hole as the election approaches. The Institute for
America’s Future, a group calling for the closure of the gap,
calculated that, on average, seniors who enrolled in the benefit at the
beginning of the year would have fallen into the doughnut hole on Sept.
22.

So this problem will get worse all the way up to election day, and the greed fest known as the Medicare Modernization Act (of which to be fair the greed of big Pharma was only one small part) may play a factor. And if it does, the obvious change that the Democrats would now put in the bill would be negotiated pricing.

That was not what Pharma wants, but of course it’s a maybe and the CEOs of big Pharma who pushed the bill through are leaving their posts and leaving the potential consequences to their successors. My guess is that those successors will wise up and figure out how to cut a more reasonable deal so that they are not so squarely in the gun sights when the nation has a real debate about health care costs in a few more years.

 

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Gregory D. Pawelski
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Gregory D. Pawelski

NCI’s Failure at assay-directed therapy Good review papers exist on cell culture assays and are increasingly appreciated, understood and applied by the private sector and European clinicans and scientists. The literature on these assays have not been understood by many NCI investigators and by NCI-funded university investigators, because their knowledge was almost always geared towards an assay technique (cell-growth) that hasnt’ been used in private labs for over fifteen years now. NCI studies never determine if “fresh” tumor assays worked. All of the considerable literature which supports the use of these assays in patient management has been based on true… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

Favorable local coverage decision (LCD) regarding Medicare payment for Cell Culture Assay Test Cell culture assay technology has been clinically validated for the selection of optimal chemotherapy regimens for individual patients. It is a laboratory analysis based on tumor tissue profiling that uses fresh human tumor biopsy or surgical specimen to determine which drugs or combinations of chemotherapeutic agents have the highest likelihood of response for individual cancer patients. Individualized assay-directed therapy is based on the premise that each patient’s cancer cells are unique and therefore will respond differently to a given treatment. This is in stark contrast to standard… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

I once thought Michelle A. had a particular agenda, but now I feel she’s flakier than first perceived (a blog groupie). Excuse Me!

Michelle
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Michelle

Notice, the logical fallacy: Argument By Repetition (Argument Ad Nauseam): if you say something often enough, some people will begin to believe it, i.e. reposting the same fallacious premise presumably in hopes it will have that effect. It’s an endless mantra from him and the “alternative” medicine crowd. Here’s what I mean: “Michelle harps on the fallacy that assay tests have no proof. What “proof” does “one-size-fits-all” cancer treatment have?” This is it. This is what he has to resort to to prove to nonbelievers that his assays show benefit. He has to criticize “”one-size-fits-all” cancer treatment.” You might believe,… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

Michelle harps on the fallacy that assay tests have no proof. What “proof” does “one-size-fits-all” cancer treatment have? It hasn’t been proven that most things medical oncologists do make any difference at all. First-line chemotherapy of many types of tumors. Second-line chemotherapy of virtually all types of tumors. High-dose chemotherapy of breast cancer. What is the standard Michelle tries to apply to cell culture assays, as the most appropriate situation? Proof? There are precious few treatments available for cancer beyond surgery and radiation therapy for local control. Cell culture assays are a test, not a treatment. You may “try” to… Read more »

Michelle
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Michelle

What’s interesting is that Mr. Pawelski and I would like to see more effective treatments for cancer. The trouble arises when there is mere speculation treated as fact, a speculation that creates fear in patients he claims to help. He has finally softened his certitude: my point with respect to cell culture assay testing is to educate patients that such techniques exist, and MIGHT be very valuable. (This is a needed change in his blog posts.) Yet, in the same post he says: “The way she was treated by “one-size-fits-all” cancer treatment should NEVER happen to ANOTHER human being.” (A… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

I assured Matt that I am not gaining any financial benefit by promoting this technology (let alone selling anything). On the internet, my point with respect to cell culture assay testing is to educate patients that such techniques exist, and might be very valuable. Especially when active chemoagents are limited in a particular disease, it makes more sense than ever to test the tumor first. I was a spouse/caregiver to an ovarian cancer patient. I became intensely interested in cancer medicine by virtue of working through, enduring and surviving my wife’s illness. I’ve gotten a street education by virtue of… Read more »

Matthew Holt
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Matthew Holt

Well done the two of you for keeping this up! Meanwhile, I don’t know anything about the science of all this but I do know that a) there is clear evidence of overuse of chemotherapy by oncologists who are definitely incented to use drugs by the way they get paid, and b) the NEJM study on OncotypeDX Testing suggests that if we looked at the subject more closely instead of dismissing it out of hand, we might discover more. So I wouldn’t be so certain, either. If Greg is gaining any financial benefit by selling this test I’m sure he’d… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

The greatest poison in all the world is an overdose of certitude. You certainly have that Michelle A. I’ve got to had it to you, you certainly have it.

Michelle
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Michelle

1.I don’t work for oncologists. 2.There’s no evidence that individualized chemotherapy assays are good science because there is no science. 3.No evidence of lives saved if pretesting was incorporated. None. 4.”The objective of pre-testing is to provide the patient with more options to discuss with their oncologist and to bring about multimodality approaches to IMPROVE the probability of a successful outcome.” No evidence. None. 5.”having a lot of tools (drugs) available and making use of various assay tests can match treatment to the patient.” Completely unproven with respect to chmotherapy assays. No benefit has ever been shown. That’s why this… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

I understand your frustration Michelle A., when good science (individualized treatment) trumps bad science (one-size-fits-all). There is seldom a “standard” therapy which has been proven to be superior to any other therapy. Even NCI admits that. The respected cancer journals are publishing articles that identify safer and more effective treatment regimens, yet few oncologists are incorporating these synergistic methods into their clinical practice. Cancer patients often suffer through chemotherapy sessions that do not integrate all possibilities. Chemotherapy drugs have a high rate of failure because they usually kill only specific types of cancer cells within a tumor or the cancer… Read more »

Michele
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Michele

“They’re here, you’ll just have to get use to it!” Is this your NYAH, NYAH! moment? As our boy, Dubya says, “Bring it on!” But let’s not do it from blind faith, as he likes to run the country, but from evidence of benefit, from which tests are approved. Unfortunately, assay researchers, as opposed to the typical assay blogger who likes to say, “Honey, you will die without my assay,” know that research, is required to show benefit. Yes, we’ve already addressed the stale “accuracy is good enough” fallacious myth and that is why these apoptosis tests are not approved….yet.… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

Michelle A. Your oppositition to cell culture assays has been erected to protect the paradigm of the best empiric treatment for the average patient, as identified in traditional clinical trials. This opposition served to protect the paradigm of drug selection with consideration of the spread between wholesale cost and reimbursement. As we have seen, the conventional approach is not working. It is extraordinary difficult to prove the efficacy of chemotherapy in general and of specific drug regimens in particular in studies of empiric-directed chemotherapy. Only with extremely large studies has it been possible to document that chemotherapy of any type… Read more »

Michelle
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Michelle

“There are a number of scientists from respected research facilities across the United States that say much of what is known to be true about cancer is false.” Who? What’s false? What’s true? “Many of the basic assumptions and theories that are driving most of today’s cancer research are false.” Really? Data please. “..clinical trials of cancer drugs are failing with painfully predictable regularity.” Really? What’s failure? “Some researchers say…” Who? YOU? You’re a researcher? I doubt it. “Drugs have been made to target and kill cancer cells.” So? You have so little understanding of cancer physiology and the difficulty… Read more »

Gregory D. Pawelski
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Gregory D. Pawelski

We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perfrom well-designed, prospective randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination. Cancer patients can’t wait another ten years to learn what is already known. There are a number of scientists from respected research facilities across the United States that say much of what is known to be true about cancer is false. Many of the basic assumptions and theories that are driving most of today’s cancer research… Read more »