Study Finds Flaws In Cancer Clinical Trials

[Hopeful]

http://www.medicalnewstoday.com/medi...p?newsid=62107

Hopeful

[heblaj01]

Older rules set by the FDA for chemo drugs have in the past (& maybe still now if they are still enforced) tended to negatively affect the true potential of some drugs in trials. This is the case of antiangiogenesis drugs which are usually slow acting & may only work as cytostatic rather than cytotoxic agents.
One of the rules was to drop from a trial any patient showing a 50% rise in tumor size even if his markers were indicating drug activity & others in the same trial were showing even more benefits.
So final trial statitics based on such rules would result in a poor response rate not to speak of the patient with advanced disease left out without treatment which may otherwise prolong life if sustained over a longer time.

[gdpawel]

At present, clinical trials are highly empirical, they test drugs on general populations and then look for a clincial response and a treatment effect that is not likely to be a chance result. However, the side effect of this is inflexibility, some patients may unnecessarily be exposed to inferior experimental therapies.

A problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don't treat populations, they treat individual patients. Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. The empirical approach doesn't tell doctors how to personalize their care to individual patients.

The number of possible treatment options supported by completed randomized clinical trials becomes increasingly vague for guiding physicians. Even the National Cancer Institute's official cancer information website states that no data support the superiority of more than 20 different regimens in the case of metastatic breast cancer, a disease in which probably more clinical trials have been done than any other type of cancer.

More clinical trials have not produced more clear-cut guidance, but more confusion in this situation. It is more difficult to carry out clinical trials in early stage breast cancer, because larger numbers of patients are needed, as well as longer follow-up periods. But it is likely that more trials would lead to the identification of more equivalent chemotherapy choices for the average patient in early stage breast cancer and in virtually all forms of cancer as well.

So, it would appear that published reports of clinical trials provide precious little in the way of "gold standard" guidance. Almost any combination therapy is acceptable in the treatment of cancer these days. Physicians are confronted on nearly a daily basis by decisions that have not been addressed by randomized clinical trial evaluation.

The needed change in the "war on cancer" will not be on the types of drugs being developed, but on the understanding of the drugs we have. The system is overloaded with drugs and underloaded with the wisdom and expertise for using them.

Patient tumors with the same histology do not necessarily respond identically to the same agent or dose schedule of multiple agents. Laboratory screening of samples from a patient's tumor can help select the appropriate treatment to administer, avoiding ineffective drugs and sparing patients the side effects normally associated with these agents.

It can provide predictive information to help physicians choose between chemotherapy drugs, eliminate potentially ineffective drugs from treatment regimens and assist in the formulation of an optimal therapy choice for each patient. This can spare the patient from unnecessary toxicity associated with ineffective treatment and offers a better chance of tumor response resulting in progression-free survival.

Identifying patients with resistant neoplasms may not only spare them toxicity but may prolong their lives, by sparing them from the life shortening effects of ineffective chemotherapy.

Patients would certainly have a better chance of success had their cancer been chemo-sensitive rather than chemo-resistant, where it is more apparent that chemotherapy improves the survival of patients, and where identifying the most effective chemotherapy would be more likely to improve survival above that achieved with empiric chemotherapy.

With the absence of effective laboratory tests to guide physicians, many patients do not even get a second chance at treatment when their disease progresses. Spending six to eight weeks to diagnose treatment failure often consumes a substantial portion of a patient's remaining survival, not to mention toxicities and mutagenic effects. In cases where there are several equivalent treatments available, patients can benefit from these assay-testing results as a supplement to other clinical data when deciding on a treatment option.

There may be some resistance to this approach from some oncologists, but no one has ever shown that harm could result from the use of these technologies.

[gdpawel]

A recent article published by the National Institute of Health concluded that "about one fourth of abstracts at American Society of Clinical Oncology (ASCO) Annual Meetings have an author with a personal financial interest." Since many of these abstracts are about the results of clinical studies, this means that the study results are being penned by authors that may have a "personal financial interest" in the outcome.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17704409&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_RVDocSum

Attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17687154&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_RVDocSum

These two articles touch on a critical subject - when an oncologist recommends a treatment the reason behind the recommendation may be complex. It can be a result of the doctor's training and experience in combination with the investments made by the hospital or the doctors own research interests or their financial relationships with various outside entities. In short, a patient and their family must be their own best advocate and get at the heart as to why a specific treatment regimen is being suggested. Don't be afraid to ask questions to make informed treatment decisions!

Source: Cancer Wire

Cancer treatments 'excessive'

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.

A 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 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.

http://jco.ascopubs.org/cgi/content/full/25/25/e31

Cancer Industry Fights To Keep Obscene Profits

The cancer industry derives most of its profits from chemotherapy. Both the drug companies and the treatment providers profit from the chemotherapy drugs and the medications used to combat the side effects. The obscene profits made off chemotherapy override any incentive to find a cure or better treatments.

Doctors administer chemotherapy in their offices, buy the drugs at a lower cost than what insurance companies and public health care programs pay and pocket the difference. This system provides an incentive to overuse chemotherapy and the most expensive medications.

http://www.lawyersandsettlements.com...a-overuse.html