1. The fact that proving efficacy and toxicity in one situation does nothing to prove efficacy and toxicity in any other situation. Both the mechanism and the subjects were different. It's hard to tell a doctor (and patient) to ratchet back on the anti-VEGF drug they're using when the disease setting is stage IV lung, ovarian or pancreatic cancer.

In "curable" diseases, therapy-related, late onset sequelae are becoming a real problem. Many of these new "targeted" therapies often get a pass on toxicities because they are just so darn cool (Herceptin and CHF in the adjuvant setting is another example).

This is perhaps why Herceptin causes heart problems. Among other things, it's an antiangiogenic. Any cancer drug may lead to serious health problems in the long term. You have to remember that all drugs, including aspirin, digoxin (Foxglove), morphine and oxycontin can and do have lethal side effects. Lots of people have died from penicillan. It's all risk/benefit ratio.

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.

Posted at 7:59PM on Aug 29th 2007 by Gregory D. Pawelski

2. What's this "so darn cool" thing? Do docs go to conferences, salivate over the latest treatment, and walk away questionless?

No.

"In "curable" diseases, therapy-related, late onset sequelae are becoming a real problem."

No, they're not becoming a large problem. We're living longer than ever. Ever.

"Any cancer drug may lead to serious health problems in the long term."

Actually, cancer itself can lead to serious health problems. So, stop therapy? Stop aspirin? Stop digoxin? Stop penicillin?

Huh?

"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."

This is clearly a ridiculous statement. There's little substance to back up this claim. It's intention, to create fear in the cancer patient about oncologist knowledge, is well, actually, frightening.

Let's take a deep breath for a moment:

"If I had an aggressive cancer, I would take these drugs -- even the new ones," Iruela-Arispe says. "If my choice is dying from cancer in six months or taking a risk of a side effect that may never happen, I will certainly take the risk. These are great drugs, but we should continue the search for better ones."

Francis says the message is not that VEGF inhibitors are bad, but that doctors and patients should be aware of the risks.

"If you get into treatments targeting this VEGF pathway, it is going to have to be very carefully done," he says.


http://www.webmd.com/cancer/news/20070823/warning-sign-for-cancer-drugs

Posted at 10:10AM on Aug 30th 2007 by hchcec

3. It is sometimes difficult to discuss the nuances of cartography with those so wedded to the flat earth concept. Chemotherapy-induced toxicities are common and serious clinical problems can adversely impact both the quality of life of cancer patients and the ability of patients to continue treatment for their cancer. Any cancer drug may lead to serious health problems in the long term. Unfortunately, any successful treatment is only as good as the drugs available, and better ones are needed before real progress is made with this disease. If oncologists would "think" beforehand, learn more to recognize the toxicities of adjunctive drugs, and take the time to think through what it is they are using them for, it could drastically reduce having to endure toxicity and allow the patient to experience significantly increased survival.

Posted at 10:10AM on Aug 30th 2007 by Gregory D. Pawelski

4. "If oncologists would "think" beforehand... it could drastically reduce having to endure toxicity and allow the patient to experience significantly increased survival."

Who are you talking about? Where are these oncologists who don't think?

The writer leads the cancer patient to believe that his or her treatment has no thinking behind its choice, when in fact there exists decades of research, highly educated scientists and medical doctors, and caring professionals who actually do concern themselves with cancer care and progress. I just don't get the incredible presumption that there's not a thinking process here. Have you worked in a lab, treated a patient? Have you taken a science class? What scientists are you hanging out with?

I mean, c'mon. Where's your data?

Posted at 12:22PM on Aug 30th 2007 by hchcec

5. If the infamous industry shill means do I get anything out of my endeavors except the satisfaction of knowing that I've helped to increase the knowledge for informed consent? I get no pay, no lectureships, no junkets, not even any free meals. I stand up for what I say by signing my own name.

Posted at 4:47PM on Aug 30th 2007 by Gregory D. Pawelski

6. One last thing, G.P.

You say:

"I've helped to increase the knowledge for INFORMED consent?"

The problem here is your use of the word informed. To be informed means that one must convey information that is based on knowledge. I repeatedly ask you for data to back up your claims. But, we never get it. What we get instead is a lashing out at scientists, oncologists, researchers, who have spent their lives fighting a very difficult disease. This is a difficult task and the critical statements made against the profession, in the way that is regularly done by you in support groups, undermines the doctor-patient relationship and creates fear in cancer patients.

Someone has to ask you for data to back up your claims. One more time (on this, your most current claim)...where is the data that oncologists do not think before giving treatment?

(Informed consent requires truth in advertising. And, no, I don't work for the industry. This is a red herring that helps you to avoid answering my question.)

Posted at 4:55PM on Aug 30th 2007 by hchcec

7. It's obvious that I've upset one person in the cancer establishment, not most patients reading this blog. The attacks by the "powers that be" to my basic theme or message of useable information, good or bad, appears to be to harsh or realistic for that person.

I sincerely care about cancer patients and cancer families no less so than oncologists and NCI researchers. I am providing information and a point of view. I am not making a decision for anyone. The cancer patient's oncologist still holds all the cards in steering the cancer patient in the direction the oncologist wishes.

I am simply giving the cancer patient and family a little more information in the most difficult of situations. People who don't want this information don't go on internet blogs looking for it. People who do want this information have their own responsibility to be capable of dealing with the unfiltered information they receive in this medium.

Posted at 9:21PM on Aug 30th 2007 by Gregory D. Pawelski

8. Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need, medical oncologist Dr. Ian Haines reported in the Journal of Clinical Oncology. Emerging evidence shows that many of the highly expensive "targeted" cancer drugs (Herceptin, Avastin and Rituximab) may be just as effective and produce fewer side effects if taken over shorter periods and in lower doses. He stated in the Journal that "it would seem that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments." He suggested the we make the search for minimum effective doses of these treatments one of the key goals of cancer research. He gave as an example, Avastin, used to fight colon and lung cancers, the dose being tested is 15 milligrams per kilogram of body weight, despite other research showing it may work with 3 milligrams per kilogram. (JCO, Vol 25, No 25, Sep 1 2007: e31-32.)

Posted at 11:35AM on Sep 1st 2007 by Gregory D. Pawelski

9. The lower dose Avastin data:

1.is from a preliminary phase III trial in Europe
2.the company-sponsored study examined Avastin in combination with a chemotherapy regimen commonly used in Europe, not the one preferred by doctors in the U.S.
3.didn't report on overall survival data.
4.didn't show the effect of prescribing Avastin at the lower dose to be superior in prolonging progression-free survival in patients with non-small lung cancer, but merely similar. A trial comparing the two doses directly is needed.
5.Reimbursement in the US is based on sales price plus a mark-up so it doesn't matter to the company what dose is given.

So Hain's comment, itself, is preliminary. There's not yet data to back his claim.

Avastin and heart failure risk? This has been known since drug approval.

Herceptin and heart failure? Herceptin-related heart problems are infrequent and may often be reversible. The researchers conclude that given the clear benefit of Herceptin in early-stage breast cancer, its use should be considered for all appropriate patients.

http://patient.cancerconsultants.com/CancerNews.aspx?DocumentId=40317

Claims require data. Informed consent requires informed knowledge.

Posted at 1:10PM on Sep 1st 2007 by hchcec

10. A recent study published in the journal of the American Cancer Society, led by Jeffrey Peppercorn of the University of North Carolina Lineberger Cancer Center, along with three researchers at the Dana-Farber Cancer Institute, found that 84% of trials with pharmaceutical-company involvement showed positive results, compared to 54% for trials without industry backing. Another previous study in oncology, looking at multiple myeloma, found that pharmaceutical studies reported positive results in 74% of trials compared to 47% of non-industry-sponsored trials.

An increasing number of drug studies are developed through collaborations between academic medical centers and drug companies. In fact, pharmaceutical-industry investment in research exceeds the entire operating budget of the NIH. It is important to understand the influence that industry involvement may have on the nature and direction of breast cancer research. Studies backed by pharmaceutical companies were significantly more likely to report positive results.

As the Haines study suggests more must be spent on analyzing drug data, we also need larger and more detailed studies to figure out why there is an association between pharmaceutical involvement and positive results. Some of the connection between industry and positive results may be because industry focuses on drug development and they do it well.

However, drugmakers are going directly to the consumer at a time when their products are indeed at the margins of evidence-based medicine. On one hand, pharmaceuticals advertise extensively and the advertising is manipulative in the extreme. On the other hand, even NCI-designated cancer centers do this sort of direct to consumer, hard sell advertising. And in cancer medicine, the media advertising is no more misleading than the one-on-one communication which often goes on between a chemotherapy candidate and an oncologist.

A Karolinska Institute in Sweden study showed that U.S. health care system is good at delivering expensive drugs, but that our health care system is not so good at simple medicine like preventive care. Our pharmaceutical-based health care system is very good at creating new health care products that will make a lot of money, but it it's something that has no chance of profit, forget it.

It doesn't take a rocket scientist to figure out that the United States does a good job of developing and delivering new and expensive drugs to cancer patients, because that is the only thing we're good at. But it'll take a rocket scientist to figure out how this makes for a better health care system.

Posted at 7:36AM on Sep 4th 2007 by Gregory D. Pawelski

11. Pawelski:

"the United States does a good job of developing and delivering new and expensive drugs to cancer patients, because that is the ONLY thing we're good at."

When you read gross generalizations like this, filled with anger and emotion, move on to the next commenter.

Posted at 1:39PM on Sep 4th 2007 by hchcec