Dr. Buzdar never made any of those statements which Adam writes in his PR.
First PR - Adam writes....
But Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study.
PR from MD Anderson on Dr. Buzdar
Dr. Aman Buzdar, MD Anderson's Vice President of Clinical Research, explained to the news outlet that the standard practice for clinical trials is that data only be released at predetermined time points defined by the research protocol or at the completion of the entire study when data are fully analyzed.
Dr. Buzdar has no associations or financial interest with this company or any other pharmaceutical company. Nor does he serve as a consultant or scientific advisor for any company.
MD Anderson was not involved in the decision to disclose the study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief that releasing incomplete research data is not accepted practice in our field.
After Phil Baumann was diagnosed with glioblastoma, his family began raising money for brain cancer research at MD Anderson. “When we hear that the money has helped more patients, it's a feeling like no other,” says Phil’s wife, Misty. “Excitement, thankfulness and happiness -- it's like 10 Christmas mornings all rolled into one.”
Dr. Mark Roh, President of MD Anderson-Orlando, states, "We are very excited to be joining this clinical trial to further advance cancer care and possibly expand treatment options to cancer patients. Our oncologists and staff are dedicated to providing our patients with every opportunity to fight their disease, and being a part of this trial will give additional research options to the brave men and women who walk through our doors."
I understand that NWBO will work with M.D. Anderson to respond to this latest Feuerstein missive. I do not see this as an important new event in the DCVax Direct trial. It is an article composed by an author will a well laid out and well understood negative agenda.
Although this is a sensational headline, it does not in anyway impugn the data that has been released about DCVax Direct nor the possible final outcomes. It is a typical strawman argument about whether it is appropriate to discuss interim data. Opinions may differ, but what NWBO has done is not unusual or unethical
This policy is intended to protect patient safety and welfare, safeguard the reputation and integrity of the
institution, preserve the integrity of affiliated research, ensure fulfillment of obligations to faculty and
Trainees, clarify that the employment obligation of employees is to the institution, and require disclosure
of all potential or actual conflicts of interest. This policy also serves the purpose of ensuring compliance
with State ethics laws and UT Board of Regents Rules, while providing the framework for rules and
procedures that will clearly delineate permissible outside activities, including relationships with for-profit
entities that further the mission of MD Anderson or that serve another scholarly purpose.
It is the policy of The University of Texas MD Anderson Cancer Center (MD Anderson) that faculty members, trainees, faculty supervisors, institutional decision makers, and investigators must follow certain procedures in order to ensure the protection of patient safety and welfare, safeguard the reputation and integrity of the institution, and preserve the integrity of affiliated research, while permitting the pursuit of relationships with for-profit entities that further the mission of MD Anderson or that serve another scholarly purpose.
These procedures are outlined in MD Anderson’s Conflict of Interest Policy for Faculty Members, Trainees, Faculty Supervisors, Institutional Decision Makers, and Investigators of The University of Texas MD Anderson Cancer Center (UTMDACC Institutional Policy # ACA0001). The Office of Research Administration (ORA) administers this policy and in conjunction with MD Anderson’s Conflict of Interest Committee, reviews financial interest disclosures required by this policy.
As required by Public Health Service federal regulations regarding its grants or cooperative agreements, MD Anderson’s ORA makes available to the public: (1) the institution’s policy on conflicts of interest; as well as (2) information related to disclosed significant financial interest(s) that are determined by MD Anderson to be financial conflict of interest(s) for senior/key personnel working on a funded research project, including:
the Investigator’s name;
the Investigator’s title and role with respect to the research project;
the name of the entity in which the significant financial interest is held;
the nature of the significant financial interest; and
the approximate dollar value of the significant financial interest.
This all sheer lie and MD Anderson shall immediately release the notice to 'The Street' being their Dr being quoted in Public as a news release.
A major clinical focus is directed to a specific form of immune suppression that is generated by the cancer cell to protect it from the patient's immune system. Understanding the clinical importance of immune suppression has led to the development of a new form of therapeutic apheresis to unblock the immune system, allowing it to destroy cancer cells. All data suggest that removing immune suppression is more important than "stimulation" of the immune system. A mature technology that removes immune suppression in cancer patients is Immunepheresis.
The technology is based on three decades of work by M. Rigdon Lentz, MD and others. They showed that cancer cells produce soluble inhibitors that block the tumor cytotoxicity of tumor necrosis factor (TNF). These inhibitors can be removed from the blood safely and efficiently; and that once removed, the unblocked immune system can rapidly kill cancer cells. In clinical experience to date this immune unblocking has yielding significant clinical responses, including complete tumor remissions.
If Dr. Aman Buzdar says results could be of anything meaning RESULTS are there, remains to be seen is from anything which is DCVax Direct!!
Several types of vaccines for boosting the body’s immune response to kidney cancer cells are being tested in clinical trials. Unlike vaccines against infections like measles or mumps, these vaccines are designed to help treat, not prevent, kidney cancer. One possible advantage of these types of treatments is that they seem to have very limited side effects. At this time, vaccines are only available in clinical trials.
There are several ways to create vaccines that might stimulate the immune system:
◾ In one approach, cancer cells (removed during surgery) are altered in the lab to make them more likely to cause an immune response and are then returned to the body. In another approach, a special virus is altered so it is no longer infectious, but it carries a gene for a protein often found on cancer cells. Once the virus is injected into the body, the hope is that the protein will cause the immune system to react against cancer cells anywhere in the body.
◾ In another approach, immune system cells are removed from the blood. The cells are treated with cytokines and exposed to killed tumor cells to make cells called dendritic cells. These cells are then injected into the body to stimulate the immune system to fight the cancer. Early results have been promising, but more studies are needed.
Combining vaccines with targeted agents or other agents to help them work better is also being studied.
A newer approach to treatment is the use of a virus, known as JX-594. This started as the same virus that was used to make the smallpox vaccine, but it has been altered in the lab so that it mainly infects cancer cells and not normal cells. A solution containing the virus is injected into liver cancers, and the virus can enter the cancer cells, where it causes them to die or to make proteins that result in them being attacked by the body’s immune system. Early results of this treatment against advanced liver cancer have been promising, even in patients who have already had other treatments, DCVax Direct does exactly same as JX-594 virus which helps to kill the Cancer Cells and boost the human immune.
NW Bio continues to make strong progress in multiple programs with two product lines, for both operable and inoperable tumors, and as NW Bio's clinical programs show encouraging early effects, Feuerstein seeks ever more sensationalized ways to try to smear the Company. This is not even the semblance of professional analysis. We condemn this attack campaign and appreciate the strong support we are receiving from shareholders, patients and other commentators. We intend to continue our progress undeterred
Dr Aman or who so ever - NEVER NEVER reply to anyone on same day. Common sense - How come Dr. Aman can reply which he is not involved in?
The Phase II stage of the trial will focus on efficacy. The primary measure of efficacy will be regression (i.e., shrinkage or elimination) of the patient’s existing inoperable tumors. Such regression is a rapid endpoint: if it is going to occur, is anticipated to occur within a couple months of treatment.
Dr never gives comments on things which he never sure or aware of ....
Secretary at MD Anderson clearly informed that send your concern by email or fax and they will reply if it is necessary and appropriate if it is required and that to in writing.
So does he understand that being said .....It is MD Anderson site .
Adam made 2 false statement
In response to my questions, MD Anderson's spokesperson asked me to speak with Dr. Aman Buzdar - Dr Aman Never answers any call from anyone. Even President Obama is on the line. Secretary asked Adam to leave his message and come back to him after Dr. Review his concern.
Why Adam is not diclosing this facts that Dr. refused to provide any further details other than looking into matters and call him back.
MD ANDERSON is a party to the patients File Records and Biopsy Performed at the Site.
There has been significant interest in this trial, and the Company has been receiving many requests for data updates, as this trial is testing a novel treatment for patients with late stage, inoperable tumors – patients for whom there are virtually no treatment options today. The data released by the Company came from the medical files at the clinical trial sites and reviews of imaging and biopsies, and was provided by the sites and pathology labs, as well as a respected and independent clinical research organization (CRO) managing the trial.
Government Emerson College, Multan, Pakistan, FSc, 1962
Nishtar Medical College, Multan, Pakistan, MB,BS, 1967
Rotating Intern, Kaukini Hospital, Honolulu, HI, 1968−1969