Wednesday, October 28, 2009

Would the government lie about the existence of an effective treatment for cancer?

Would the government deny that competent, controlled clinical trials have demonstrated there is a drug that is effective against most types--and stages--of cancer, that is safe, inexpensive and free from serious clinical side effects?

The answer is 'yes.' The drug's name is hydrazine sulfate. If you're a reader of the blog MedTruth, you've already seen several articles on this drug. But perhaps you'd like to witness the actual commencement of this official lying and opposition to this drug.

The year was 1976, the date, March 8. Because of my concern regarding controversy and irregularities by cancer authorities in the early stages of clinical testing of the drug hydrazine sulfate, developed by the Syracuse (New York) Cancer Research Institute, veteran Syracuse Congressman James M. Hanley (Chair of the House Post Office and Civil Service Committee and a member of several important subcommittees, including Manpower and Civil Service, Housing and Community Development, Institutions and Finance, Small Business Oversight and Minority Enterprise, Small Business Administration Legislation), requested a "status report" on hydrazine sulfate from the director of the National Cancer Institute (NCI)--part of the federal government and this country's, and the world's, most influential cancer agency. Within two weeks he received a reply that stated: "Hydrazine sulfate has been tested in the Soviet Union at the Petrov Institute in Leningrad [St Petersburg]. In a clinical study directed by Dr. Michael Gershanovich, no evidence of meaningful anticancer activity was reported. This information was communicated to the NCI under the Joint U.S.-U.S.S.R. Health Agreement of 1972." Congresman Hanley forwarded me the reply.

The letter was devastating to me personally. Although I had known that cancer scientists in the Soviet Union were performing mouse and rat studies with hydrazine sulfate (they had picked up from our original work published in the medical literature), I had no idea they had already performed human studies--and that these studies were negative. Reading this letter--and what it said--constituted the lowest point in my professional career. I was dejected the entire day, unable to believe the contents of the letter.

The very next day a scenario occurred that could only have been fashioned in Hollywood. The mailman came to the large plate-glass front doors of our reception suite (where I was at the time) and I could see he was holding a five-by-seven inch shiny manilla envelope in his hand, the kind one used to see in the Depression days of the 1930s, and to boot it was totally unsealed. He entered the suite and handed the receptionist the envelope, for which she had to sign. It was registered and postmarked "Leningrad." We did not know anybody in Leningrad, nor were we expecting mail from Leningrad. The receptionist handed me the unsealed envelope and we all--several of our laboratory staff had gathered in the reception area--looked at each other puzzled. I removed the contents of the envelope. It was a reprint of a scientific study--all in Russian, except for the English abstract (summary) at the end of the article. The principal investigator was indicated as Dr. Michael L. Gershanovich and the study site as the N. N. Petrov Research Institute of Oncology. The title of the paper was "Experimental and Clinical Data on Antitumor Action of Hydrazine Sulfate," and the English summary read:

"Clinical observations enabled us to state a definite
therapeutic effect of hydrazine sulfate in patients
with lymphogranulomatosis [Hodgkin's and non-
Hodgkin's lymphoma] and malignant tumors of
various localizations in far-advanced stages, where
other measures of specific therapy failed." [The
summary added that because of the favorable
outcome, the study was being enlarged immediately.]

I was stunned to read this summary. It was from the same Russian study to which the NCI reply to Congressman Hanley referred--only it was exactly opposite of what was communicated to Congressman Hanley. Upon translation of the entire study, the following therapeutic effects of hydrazine sulfate in 48 "factually terminal" [stage 4] patients--with different types of cancer--were detailed: "diminution or disappearance of pleural effusions and ascites [fluid accumulation in the chest cavity and abdomen, containing individual cancer cells], lowering of fever, normalization of laboratory indices, diminution or disappeance of pain, increased appetite with cessation of weight loss or weight gain, increase in strength, disappeance of hemoptysis [spitting of blood in patients with lung cancer], increased overall performance status [ability to ambulate and perform work], tumor stabilization [no increase in tumor size], tumor regression." Therapeutic benefits were registered without significant clinical side effects: "Pharmacological characteristics of this compound demonstrate that the antitumor effect is observed in doses which do not produce toxicity."

No meaningful anticancer activity?

As to the important question whether the NCI response to Congressman Hanley represented an innocent error on the part of the NCI or a deliberate fabrication, a further letter from the NCI, dated June 22, 1976, stated: "An abstract [summary] of the Gershanovich study appeared in Cancer Therapy Abstracts (Vol. 16: No. 4 [19]75-2046), a journal published under contract to the NCI." This published abstract antedated the NCI's response to Congressman Hanley by more than six months. Thus, at the time the NCI was writing to Congressman Hanley that the Soviet data were negative, the NCI already knew these data were positive.

Why the deception?

What was the meaning of this misinformative response by the NCI?

Hydrazine sulfate was the first drug for generalized--any type of--cancer. It was developed by the Syracuse Cancer Research Institute, a small, private cancer research organization with an annual budget not exceeding $200,000. If you were a member of the House or Senate Appropriations Committees, would you authorize billions of dollars annually, as a result of the National Cancer Act of 1971, directly to the NCI--in the face of a small private laboratory which had just come up with the first useful drug for all cancers, on a budget of less than $200,000? You'd have to say "Whoa--let's reevaluate this whole situation."

Thus, in framing a deliberate lie to Congressman Hanley--in turning its guns against hydrazine sulfate--the NCI was fighting for its life. In perceiving hydrazine sulfate as a threat to its existence, the NCI was fighting to preserve its hegemony over the network of all cancer funds and its central position in the constellation of all cancer efforts.

As many readers of MedTruth know, over the ensuing years the NCI maintained its resistance to hydrazine sulfate, referring in cancer textbooks to the ever-enlarging Russian controlled clinical trials demonstrating statistically significant antitumor and anti-cachexia effects (see above) in otherwise unresponsive patients--as showing only "hints of subjective activity," while at the same time not even acknowledging the published Phase III randomized, double-blind Harbor-UCLA studies demonstrating, again statistically significantly, that hydrazine sulfate normalizes the abnormal metabolism associated with cancer cachexia--(i.e., associated with over 70 percent of all cancer deaths).

But not until 1989 did it occur to NCI that it would have to undertake controlled clinical trials of its own which might counter the Russian and Harbor-UCLA studies before the scientific and medical communities might believe its adversarial position on hydrazine sulfate. Accordingly, in 1989 NCI took over all clinical testing of hydrazine sulfate in the U.S., prohibiting (by grant denial) Harbor-UCLA--which up to that time had performed and published almost 10 years of increasingly positive studies on hydrazine sulfate--and by association any other U.S. cancer center from any further clinical study of hydrazine sulfate. Thus, in 1989 the NCI became the only player in the clinical testing of hydrazine sulfate within the United States.

The NCI sponsored three studies of hydrazine sulfate, parts of which were performed at various cancer centers and hospitals throughout the U.S. But before going further, it is necessary for you to become acquainted with the Helsinki Declaration.

The Helsinki Declaration--a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory-- is an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land," requiring all human biomedical research to conform to its stated principles, and to so acknowledge in all experimental protocols and published studies.

All controlled clinical trials performed in accordance with the Helsinki Declaration indicate--without exception--the efficacy and safety of hydrazine sulfate. These include the 17 years of multicentric Phase II Russian studies and the 10 years of Harbor-UCLA randomized Phase III studies--performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and medical journals.

The only controlled clinical trials to indicate the non-efficacy of this drug were those sponsored by the National Cancer Institute. However, these were in violation of the Helsinki Declaration (the "generally accepted standards" rule) by virtue of their use of incompatible agents (medications) with the test drug and therefore declared by this Declaration to have no scientific standing. (Use of incompatible medication in the presence of a test drug can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.)

Most major media science writers and personnel are reluctant--even fearful--to touch this story. The idea that there could be an existent, effective cancer treatment--which the government refuses to acknowledge--is almost preposterous. But in those instances where reporters and other media representatives have made inquiries to the National Cancer Institute, stating their plans for a possible story on hydrazine sulfate, they receive the following type of reply:

"How could you perpetrate such a cruel hoax on the American people? You would be giving hundreds of thousands of people false hope."

Here is the 'cruel hoax': The combined Russian and Harbor-UCLA studies, the only controlled clinical trials performed in conformity with the Helsinki Declaration, state that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than half a million would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (> 10 years) "complete response," i.e., survival.

This 'cruel hoax' must out. NCI's well-kept 'secret' must out. The major media must have the courage to take on this difficult story and inform the American people that there is an effective cancer treatment out there, one that competently performed clinical trials have identified as capable of extending benefits to even very advanced cancer patients.

I am asking each of you who reads this communication to send a copy to anyone you know who has cancer, to anyone you know who may be in a position to majorly publicize--to "break"--this story. To your doctor. Your health care provider. To the earnest people in hospice who care for human beings in their last weeks and months of life. To your Congressmen and Congresswomen. Ask them to do something about this tragic situation which keeps really ill people from a drug which competently performed clinical studies say might help them and only incompetently performed studies say otherwise....

Thursday, June 25, 2009

Meditated manslaughter

Today I want to inform you of a recent occurrence, one of the most diabolical happenings in medicine I have ever been aware of, that has the capacity to negatively affect the life of anyone who has cancer and indirectly negatively impact the life of every man, woman and child in this nation, even abroad.

In the June 1, 2009 issue of Newsweek magazine there was an insert of the Syracuse (NY) Cancer Research Institute in the cancer care section, calling attention to the last blog on MedTruth, "If you have cancer, even advanced, studies show this drug may help save your life...." The drug referred to was hydrazine sulfate, developed by the SCRI, though the insert did not name the drug. The blog reviewed in detail the advantages of especially late stage cancer patients having a trial on the drug, based on controlled clinical trials performed in accordance with internatiionally authorized biomedical procedures, as well as the National Cancer Institute's (NCI's) historical opposition to it. This insert appeared in Newsweek's New York state, Northern New Jersey and Washington, D.C's editions.

Those of us responsible for this insert thought that the potential for many cancer patients and their families to read this blog was high, and therefore we undertook to place comprehensive information on hydrazine sulfate on-line. To that end we published on Wikipedia--the Internet's encyclopedia--a full informational statement on hydrazine sulfate, inclusive of scientific background, clinical indications, clinical trials, side effects, drug incompatibilities, costs and a Reference list from the medical literature. We strived and hopefully succeeded in providing non-biased, 'even-handed' information, so that readers of this important statement might have a well-balanced idea of this drug and its expectations.

This statement lasted on Wikipedia only 24 hours. Approximately one day later, it was replaced by a totally new statement--not of our doing--which retained only vestiges of our original statement. The new statement was seemingly the work of National Cancer Institute (NCI)-oriented forces arrayed against hydrazine sulfate for many years and aroused by the Newsweek's insert appearance in the Washington, D.C. area, home of the NCI (Bethesda, MD).

But these NCI-oriented forces did not want readers to see the non-prejudicial and medically and scientifically correct material we originally published on Wikipedia. Rather they wished to publish their own statement, and to that end they convinced the editors of Wikipedia to remove our statement totally and substitute one of their own.

The new statement was startling in its content of misinformation, in its wholesale substitution of fiction for fact, as well as presentation of slanted innuendos, aspersions and outright fabrications.

The "new" Wikipedia piece states: "The California [Harbor-UCLA Phase III randomized, placebo-controlled clinical] trials saw no statistically significant effect on survival from the treatment." But what the California studies actually reported in their published, peer-reviewed paper was exactly the opposite: "For the PS [Performance Status] 0-1 patients [earlier patients] survival was [statistically] significantly prolonged with hydrazine sulfate compared with placebo (P = .05) [measure of positive statistical significance]. The survival at 1 year was also significantly increased (P = .05) for hydrazine sulfate compared with placebo (42% alive v 18%, respectively)" (Journal of Clinical Oncology 8:9-15, 1990). We e-mailed this direct quote of the California studies to Wikipedia twice. The result? Wikipedia continued to publish its statement that the California studies showed no statistically significant survival increase from hydrazine sulfate treatment.

In another example, the new, substituted Wikipedia piece stated:

"Later randomized controlled trials failed to find any improvement in survival, with some trials finding...poorer quality of life." These "later" trials are the NCI-sponsored studies of hydrazine sulfate. Those of you who read our previous blog referred to above will remember that these are the same studies found to be in violation of the "generally accepted standards" rule, Principle 1, of the Helsinki Declaration, by virtue of their use of incompatible medications (alcohol, tranquilizers, sleeping pills) in the presence of a test drug (hydrazine sulfate, an irreversible MAO inhibitor).

The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the heinous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research, to which the United States is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the heart of all clinical studies and informed consent--and as such represents the international "law of the land"--and requires all human biomedical research to conform to its stated principles and to so state in all published studies and research protocols.

Principle 1, the paramount principle, of the Helsinki Declaration states: "Biomedical research involving human subjects must conform to generally accepted scientific principles...and be based on a thorough knowledge of the scientific literature." Most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.

By virtue of NCI's use of incompatible medications in its sponsored, "later" studies of hydrazine sulfate, the Helsinki Declaration declares that these "later" studies have no scientific standing and that the results of these trials are null and void. The Helsinki Declaration further states, regarding these studies (Principle 8): "Reports of experimenation not in accordance with the principles laid down in this Declaration should not be accepted for publication."

The new, substituted Wikipedia statement omits entirely any mention of the Helsinki Declaration, or of these "later" trials being in violation of this Declaration, or of the fact that in none of these "later," published studies or research protocols (#'s 8931, 89-24-51, 89-49-51) is there any statement that these studies were carried out, or to be carried out, in accordance with the Helsinki Declaration. Yet by allowing these NCI-oriented forces' assertion that these "later" trials failed to find any survival benefit and knowing that this assertion was incorrect, and in making no mention of the Helsinki Declaration, Wikipedia did not seemingly care that a startlingly erroneous impression was being made on the American public, with potentially very serious consequences.

The effect of misrepresentations such as the above is two-fold. Foremost, it promotes increased physical and psychological distress and ill-health in cancer patients by sending an incorrect signal to the lay and medical public. To doctors and patients alike it says that hydrazine sulfate is not effective and may even be harmful. Whereas the peer-reviewed medical literature in fact documents that controlled clinical studies, performed in conformity with the Helsinki Declaration, indicate--without exception--the efficacy and safety of hydrazine sulfate in cancer patients of all kinds and at all stages. These properly controlled clinical trials demonstrate that of every million late stage, unresponsive cancer patients given hydrazine sulfate, more than 500,000 would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.

The effect of the Wikipedia misrepresentations--by dissuading cancer patients (and their doctors) from a trial on hydrazine sulfate and thus a 50 percent chance of improvement in their status--is to promote increased suffering and death. As such--by acquiescing to NCI-oriented pressures (e.g., change of the actual medical literature from reading "statistically significant increase in survival" to non-efficacy)--Wikipedia makes itself a direct participant in the 'meditated manslaughter' of cancer patients all over the world.

Of perhaps equal consequence, misrepresentations such as the above send a message to the public that its institutions promoting and safeguarding First Amendment rights, such as Wikipedia, are susceptible and vulnerable to government-sponsored pressure to change truth to fiction, without an investigation of the merits of these changes. The presentation of false and/or misleading information as truth not only acts to dupe the public but, more importantly, to dilute the integrity and reliability of our public institutions.

What can be done to rectify this unfortunate situation? Undue, if not improper, government-sponsored pressure must be corrected at government levels. We can each contact our representatives and senators in Congress, calling attention to the sponsorship of governmental forces threatening to destroy what have become our free institutions, such as Wikipedia, and their dissemination of factual information to the American people, especially in regard to the public health. You will find that many of our Congressmen and Congresswomen will be responsive to this concern.

Friday, February 27, 2009

If you have cancer, even advanced, studies show this drug may help save your life....

A year ago, on February 21, 2008, I placed a blog on MedTruth, "A Dog Has a Better Chance of Recovering from Cancer Than You Do," in which I attempted to show, in dramatic fashion, that the public is being "hoodwinked" from using hydrazine sulfate for human cancer, principally by the U.S. National Cancer Institute--part of the federal government--whereas the veterinary industry is largely immune from this constraint, using hydrazine sulfate on animals sick with cancer, many of whom, as a result of this treatment, are being reported to have staged significant or complete recovery. I went on in this blog to show that it was our National Cancer Institute (NCI) which was knowingly spreading misinformation on this drug to the public and to the medical profession, in an attempt to keep it from becoming adopted for routine use in human malignancy.

The reason for the present blog is to emphasize the great possibilities for improvement and curative effect by this drug for individuals with cancers of almost all types--and at all stages--whether hydrazine sulfate is used by itself, with chemotherapy or radiation therapy, or with other modalities of cancer treatment, and eliminate, to the extent possible, the "contest" imposed on this drug by the NCI.

Controlled clinical trials, done in conformity with the Helsinki Declaration, show that of every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, more than half a million would receive measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long term (>10 years) "complete response," i.e., survival.

These are truly late-stage patients--i.e., those who have become refractory to their treatments or were never responsive to them in the first place. (It would be expected that in "earlier" patients the foregoing very favorable results would be even improved.)

These clinical results emanate from 17 years of Phase II multicentric clinical trials headquartered at the Petrov Research Institue of Oncology in St. Petersburg (with participation of the Herzen Institute of Oncology, Moscow; Oncological Institute of Lithuania, Vilnius; Institute of Oncology of the Ukranian Academy of Sciences, Kiev; and Rostov Institute of Oncology and Radiology, Rostov-an Danou)--and 10 years of randomized, double-blind Phase III clinical trials at Harbor-UCLA Medical Center in California, performed by scientists considered among the most outstanding and experienced clinical cancer investigators in the world and published chiefly in leading U.S. peer-reviewed cancer and scientific journals.

The Helsinki Declaration--an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered the hideous human medical "experiments" inflicted on helpless human beings by the Nazis--is a multinational ratification of principles governing human biomedical research studies, to which the U.S. is a major signatory, put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. This document lies at the very heart of all clinical studies and informed consent--and as such represents the international "law of the land" and requires all human biomedical research to conform to its stated principles.

The only controlled clinical trials to find this drug non-effective were those sponsored by the U.S. National Cancer Institute--which were in violoation of the Helsinki Declaration by their use of incompatible agents in the presence of a test drug. The paramount principle--Principle 1--of the Helsinki Declaration states: "Biomedical research involving human subjects must conform to generally accepted scientific principles...and be based on a thorough knowledge of the scientific literature." Most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial, since such use can result in the grave illness--or death--of a patient, as well as cause a negative drug study. Use of incompatible agents in a drug study is virtually unknown in human biomedical testing.

In the blog, "A Dog Has a Better Chance...." it was shown that the NCI-sponsored studies, out of conformity with the Helsinki Declaration by violation of the "generally accepted standards" rule (Principle 1), were also under the leadership of inexperienced or ethically compromised investigators, were not "juried" in the usual manner (it was not clear whether they were subject to outside, independent peer-review prior to publication), were "interconnected"--i.e., not independent of one another (thus no independent conformation was possible), and were subject to an accompanying NCI editorial containing blatant, unscientific language, referring to hydrazine sulfate as a "vampire," thus impairing their "legitimacy" as impartial, objective scientific investigations.

In contrast, the Petrov and Harbor-UCLA studies were in full compliance with the Helsinki Declaration, were carried out by experienced, world-class investigators not involved in any irregularities or conflicts of interest, were subject to outside, independent peer-review before winning publication, were not "interconnected" and thus constituted independent confirmation of one another (reinforcing the validity of their individual data). These studies were carried out in strict accordance with internationally established and recognized principles and contained no additions or modifications which might act to dilute or question their scientific, impartial, objective integrity.

It is important to note that while the NCI is the largest cancer agency in the world and its scientific opinions considered most authoritative and regarded by the medical profession in the highest repute, once a study is incompetently performed--in this case in violation of "generally accepted scientific principles," in violation of an international Agreement of principles governing allowable human biomedical research procedures, to which the United States is a signatory--it doesn't matter what the "credentials" of the sponsoring organization are or in what esteem it is held, its studies are invalid. Period. Science declares they are null and void and must be excluded from any treatment options.

There are only two sets of valid, controlled clinical trials--those which are in full compliance with the Helsinki Declaration--on hydrazine sulfate: the Russian (Petrov) and the Harbor-UCLA data. Both sets of studies show the same results: In late-stage patients who are or have become refractory to all treaments, hydrazine sulfate produces an approximate 50 percent response rate. 50 percent of these "factually terminal" patients respond with "moderate-to-marked" symptomatic improvements (decrease in weakness, pain and other cancer-specific symptoms, return of appetite, well-being), tumor stabilization (no tumor progression), tumor regression, or a combination of these effects. These benefits will persist from months to years, and in some cases will endure long term (>10 years), accompanied by complete response (total remission of disease).

These results are not a bad "scorecard" for those who have only "30 to 60" days to live, who are in the throes of weakness, pain and organ failure. The point is, there are no valid, controlled clinical data to disagree with these results.

Then why wouldn't--shouldn't--all patients with cancer want an immediate try on hydrazine sulfate? The results suggest that all unresponsive patients--or those growing weaker on their present therapy--who have no further treatment options available, should. Even earlier patients whose disease is stable or in remission, should consult their physicians regarding the advisability of adding hydrazine sulfate to their present regimens.

This move could be life-sparing or life-saving to you if you have a malignant disease. Regarding this drug's toxicity, since hydrazine sulfate is not a cytotoxic agent (cell-killer), side effects have been characterized as "mild" and frequently transient. Controlled clinical trials have demonstrated no incidence of carcinogenicity or documentation of organ failure as a result of hydrazine sulfate therapy: "There were no significant differences between the protocol arms with regard to myelodepression, gastrointestinal toxicity, renal toxicity, cardiopulmonary toxicity, or neurotoxicity."

Many of you know me as the developer of hydrazine sulfate as an anticancer agent and therefore it would be expected to be in my--"Dr. Gold's"--interest to promote this drug. But it is not Dr. Gold talking. Not Dr. Gold making these recommendations. It is the studies. The contr0lled clinical trials performed within the confines of the Helsinki Declaration. The controlled clinical trials performed in accordance with internationally accepted scientific principles of experimental biomedical study conduct. Dr. Gold is merely quoting the results of these studies.

These studies in essence suggest that it would be sheer insanity for a cancer patient failing current therapy, not to try hydrazine sulfate. To wait until his/her disease becomes truly terminal, from which there is no return.

But when consulting your doctor, you may hear remarks in good faith such as: "The National Cancer Institute has tested this drug and found it to be ineffective." "This drug's been around a long time. If it were any good, we'd know about it." "This drug is very toxic." "There is no credible evidence that this drug has anticancer activity." Remarks such as these from a trusted medical advisor can serve only to discourage and dissuade you from a try on this drug.

Know, however, there is but one judgment--the controlled clinical trials--that can advise whether a drug trial may be beneficial. The controlled clinical trials properly done--i.e., the Petrov and Harbor-UCLA studies. Your doctor may be unaware of these. Your doctor may be aware of only the incompetently performed National Cancer Institute-sponsored studies, those in violation of the Helsinki Declaration.

You can present your health care provider with copies of the actual Petrov and Harbor-UCLA studies, performed in compliance with the Helsinki Declaration, by visiting the Web site scri.ngen.com and clicking onto "Articles." To the left of each listed article is an icon. By clicking onto the icon, a one-paragraph summary ("abstract") of the published study will appear. By clicking onto the title of the study to the right of the icon, the entire published study will appear. Either the summary or the entire article, as they appear in the medical literature, can be downloaded and then presented to your physician.

Your physician will then have the opportunity to review the pertinent data--the results of properly controlled clinical trials--he/she may not have been previously aware of, and then discuss with you any recommendations as to the appropriateness of hydrazine sulfate as a treatment option for you.

Hydrazine sulfate is presently available by a doctor's prescription filled in a compounding pharmacy. A listing of compounding pharmacies nearest you may be obtained from The International Academy of Compounding Pharmacists, Houston, Texas, 800-927-4227.

As a last word, I know it sounds almost absurd to have a cancer drug that can induce significant anticancer response, largely ignored by the medical establishment and by specific cancer organizations and agencies, such as the National Cancer Institute. But the reality is that the only controlled clinical trials of this drug not in conflict with the internationally ratified Helsinki Declaration--the Petrov and Harbor-UCLA data--say this is the case: That upwards of 50 percent of all cancer patients, even those who are late-stage, can expect an improvement in their cancer status as a result of this treatment.

Tuesday, December 9, 2008

Can the pharmaceutical profit motive be subdued?

Are pharmaceutical companies today uncontrolled in their lust for profits--at the expense of drug utility and safety? In our nightly television news broadcasts the frequent pharmaceutical ads must portray, by FDA rule, the side effects of each drug. In many instances the side effects are horrific--but in practically each instance the drug advertised is very expensive and this, not its "therapeutic" effect, is the reason it is being promoted. Do pharmaceutical companies really care about the welfare of patients, or is patient welfare merely the excuse to amass large profits?

A few weeks ago there was an Internet report that one of our largst pharmaceutical companies, Pfizer, Inc.. was "shifting its research focus to diseases that have high potential for high profits," such as in "oncology [cancer], pain and Alzheimers disease." What happens to lesser illnesses that affect major portions of the populations--illnesses that may not perhaps require expensive medications? Do they go by the boards? Suppose a drug company or companies developed a drug that could adequately treat a common illness--but there was no or little profit in it? Would they go ahead with it? Would they place expensive ads on television dramatizing its curative effects? Full-page ads in the medical journals, in consumer-read national magazines? Not according to the pharmaceutical news reports appearing in the media. Not according to the constantly escalating prices of commonly used and expensive drugs--heartburn medications, hormones, anti-arrhythmia medications--which have been on the market for years, some of which force especially older people to choose between paying for these expensive medications and buying food.

Years ago the drug manufacturing profession used to be known as the "ethical pharmaceutical industry," in contradistinction to patented or other preparations hawked to the public by commercial promoters ("Carters Little Liver Pills"). Ethical pharmaceuticals included companies primarily engaged, under federal regulation and supervision of law, in manufacturing and fabricating drugs--in the form of pills, ampules, ointments, powders and suspensions--to the medical, dental and veterinary professions, which have been shown to be medically useful to the public and to veterinary patients. The word "ethical" embraced this industry's image for product honesty and portrayal of sincere helpfulness to humanity as the primary purpose of its business undertakings.

Today?

Is there anyone in the drug industry that cares about the public? Is there any CEO, CFO, COO or company chairman or president that knows anything about the drug trade? About drugs per se? Who is not primarily a business person? Who is not primarily concerned--obsessed--with profits? Who does not think the term "ethical" laughable--an appellation that belongs in the last century?

The announcement by Pfizer, Inc., that it will now concentrate on drugs only with a high profit potential--is now industry-wide. Only with few exceptions all pharmaceutical companies are adopting this financial strategy. What effect will it have on you? What effect on the population? On businesses and industry? On our national welfare?

There are two aspects of drug pricing that need to be addressed and--in my estimation-- immediately corrected. Runaway drug 'caps.' And, in many cases, initial--obscene--drug pricing.

As part of current, federal health laws, there are no 'caps'--upper limits--on prescription drug prices. Thus while those enrolled in various health plans may pay only a fraction of retail drug prices for their prescriptions, there is no cap on the drugs' retail pricing. The drug companies are free to charge whatever they want. People, for example, in a drug plan paying only a modest amount for a prescription item, may find their out-of-pocket expense for it double by the next year. And people who are in no prescription plan--or those who have reached the 'doughnut hole' of their plans--might no longer be able to afford the same prescribed drug one year later. From a pricing point of view the pharmaceutical companies are not primarily concerned whether people are in a drug plan, they--the companies--are free to raise the price of their drugs as often and to the exent they see fit.

As to the pricing of new drugs, especially those for treating cancer, the sky's the limit. For example, the drug Erbitux was initially priced at $12,000 per month and was subsequently raised to $18,000 per month (even though studies showed it to be only minimally useful). The drug Avastin was priced at $46,000 to $56,000 per-patient cost; Vectibix, $36,000; Lucentis, $48.000; Revlimid, $67,000; Sutent, $46,000; even single injections of simple colony-stimulating agents, for example those to increase a patient's production of red or white blood cells, $2,000 to $7,000 per injection. Do you mean to say most individuals can afford these obscene and unneeded payments? No, they can't. But the health insurance plans all authorize them. So the payments are spread among the entire membership of these plans, among the businesses and industries that underwrite these plans for their employees and among the federal and state governments.

Thus, in their pricing--and in their unbridled avarice--the pharmaceutical companies are succeeding in bringing down the average individual, in reducing--to unncecessary lengths--
the financial wherewithal of individuals to bring up families and to otherwise enjoy life's many directions.

But obscene pharmaceutical prices are not only bringing down individuals and their families, they are also contributing to the demise and "foreclosure" of business and industry. Many of the country's businesses--large and small--have either collapsed or left these shores because costs in underwriting the health and prescription plans of their employess have constituted the "straw that broke the camel's back.' And, in like manner, ever-increasing health and prescription costs are eroding the national welfare, helping to create a negative impact on the country's gross domestic product and services.

How can we "rescind" the excess profit motive of this industry? How can we restore the "ethical" to pharmaceuticals? How can we damp the greed of our health insurers--whose executives, often controlling the medical decisions of physicians, frequently walk away with millions of dollars they have managed to squeeze from their hapless memberships annually?

There is a way. And that is that this runaway "health machine" must be regarded in the same way as a war. If our nation can contribute billions to an actual war, it can contribute these kind of funds to what is actually an ongoing war--health costs eating up the wherewithal of people and the industrial backbone of this nation. We must bring into being a type of universal health care whereby people no longer have to worry about having sufficient money to cover their families' health and prescription costs, whereby businesses and industry are freed from the constraint of underwriting health costs for their employees in order to stay in business.

And at the same time, we must tame these costs. We must rescind them to levels that are commensurate with reasonable profits. We must regulate them and not allow the genie of greed to run rampant in today's health sector of society.

Health care is one of the most important issues that will confront the new administration. There is every hope that this new administration and its determined president will devote its considerable resources to finding a way of adequately resolving this demanding question.

Saturday, September 27, 2008

"Stand Up to Cancer"

About a year ago a blog was published on MedTruth, "Is Bigger Better?" describing the evolution of large-scale cancer research organizations, i.e., in excess of 20,000 members, whose growth was associated with a considerable slowing of important advances in cancer, with a "gobbling up" of cancer research funds appropriated by Congress to the annual budgets of the National Cancer Institute (NCI) and from other sources, and with a possible, paradoxical lessening of opportunity for the truly gifted, for young investigators whose ideas may be "outside" current cancer concepts--whose scientific thinking may harbor the truly great discoveries to come. The blog asks: Is bigger better? Or is big brother somehow, invisibly, paradoxically acting to smother--to exclude from opportunity--the most gifted of its ranks?

On Friday evening, September 5, 2008, all three major television networks--NBC, ABC, CBS--simultaneously telecast a live, star-studded, hour-long, commercial-free telethon, "Stand Up to Cancer," in Los Angeles, attended by thousands of people and dignitaries, aimed at raising large amounts of money for cancer research. Present were celebrities from the entertainment world, such as Jennifer Aniston, Halle Berry, Keanu Reeves, Jack Black, Patrick Swayze, Billy Crystal and others, presidential nominees John McCain and Barack Obama, and network news anchors Katie Couric, Charles Gibson and Brian Williams, who acted as emcees. People and business organizations were urged by these celebrities to call in their donations, while other stars from the entertainment industry--America Ferrera, Christine Ricci, Neil Patrick Harris, Kirsten Dunst--answered phones. Other stars, Jennifer Garner, Forest Whitaker, and again Halle Berry, read personal accounts from patients battling cancer, while cancer "survivors" Elizabeth Edwards (wife of former presidential candidate John Edwards, now battling recurrent breast cancer) and Lance Armstrong recited U.S. and global cancer statistics. This was an unprecedented effort to raise funds for cancer research in order to break the existing bottleneck to effective cancer treatments.

According to an ABC News update on Thursday, September 11, 2008, the "Stand Up to Cancer" telethon raised "one-hundred million plus" dollars. This seems like an enormous amount of money raised by this most significant and monumental effort. Will it increase the amount of cancer research funds by 100 percent? By 50 percent? By 10 percent? How significant was this fund raising effort by this distinguished, if not spectacular, gathering of celebrities, cancer research advocates, scientists, news anchors, even the two 2008 major presidential nominees--speaking for the necessity to raise more funds for cancer research, exhorting the nation's private resources, individuals and industry, to come together in a convincing demonstration of the need and willingness of the public to sponsor more effective cancer therapy. "100 million+" is a lot of money. But is it?

The cancer research budget for the National Cancer Institute (NCI)--part of the federal government--as allocated by Congress for fiscal 2008, i.e., currently, is $4.8 billion. This is 48X the funds raised by Stand Up to Cancer (SU2C). But there are other sources of federal cancer research dollars, as well as sources from the private-sector, such as the American Cancer Society (ACS); according to its Annual Report the ACS allocated $146 million to cancer research in 2007 (about the same for 2008). Thus the total available federal and private-sector cancer research funds are at least $5.0 billion annually, and the additional funds raised by this extraordinary gathering of dignitaries, celebrities, scientists, presidential nominees, news anchors, cancer advocates--$100 million--represents only 2 percent of available, annual cancer research funds. Will this make a significant inroad against cancer?

These additional funds raised by SU2C are to be relegated largely to translational cancer research. Translational cancer research seeks to convert ("translate") scientific "discoveries" that have been accumulating at the laboratory level--which have to date not resulted in any clear-cut clinical advances--to actual, new, near-term therapies that will significantly benefit cancer patients. However, it must be borne in mind that critics of this type of cancer research have alleged that many of these discoveries--made by the armies of members (20,000+) in large-scale cancer research organizations are artifactual--i.e., not real--in nature, and the reason they cannot be "translated" into effective cancer treatments is because they are intrinsically faulty.

The American Association for Cancer Research (AACR)--one of the large-scale cancer research organizations referred to in Is Bigger Better?--has been selected by the Scientific Advisory Committee of SU2C to administer these new funds. The AACR is a private organization made up of scientists, clinicians, educators and administrators. Many in its membership (currently 24,000) are at the heart of all--and the leadership of many--cancer research organizations, cancer programs and cancer centers in this country and the world over. This organization over the years sponsors annual scientific symposia, has raised funds for myriad cancer colloquia and causes, maintains official liaison and interacts with the NCI, ACS and other important cancer groups, is the sponsor and publisher of well known cancer journals, has inaugurated its own charitable foundation--but has never been the actual controller of the type of funds raised by SU2C. If all $100 million go to the AACR, it will represent a windfall for this organization, the magnitude of which it has historically never known.

On September 9, 2008, the AACR issued an Internet advisory stating it will participate in "selecting the most promising research projects" for funding (from the new SU2C funds), that the new funds would enable the "best and brightest" investigators from leading institutions around the world--usually senior investigators--"to work together." What follows is a series of words and phrases--"collaborative efforts," "Dream Teams...of top investigators who have never worked together," "team-approach, rather than competition"--ominously reminiscent of a Communist manifesto, such as would send author and philosopher Ayn Rand (who championed the individual as the "supreme" value of society) spinning in her grave (her portrait graces the 1999 U.S. first-class postage stamp). I am reminded of the get-together of pianist Arthur Rubenstein, cellist Gregor Piatigorsky and violinist Jascha Heifetz, regarded as among the greatest living musicians of their time or of any time--for a recording session. The trios to be recorded by these outstanding musicians--because of their brilliance--would be so great as to be "transcendental." But they weren't transcendental. They were a flop. Because each artist was a "virtuoso" in his own right, each had different "takes"--which did not mesh--on the trios recorded.

In its advisory the AACR emphasized the value of a "team-oriented" apporach, implying that true achievement is more likely to be the results of "collective," i.e., "collaborative," efforts. Nothing could be further from the truth. Historically true achievement--especially in science and medicine--was/is the result of one person. One mind. One brain.

August Kekule in 1865 (rumored the result of a reverie, based on his 25 years of prior work) discovered the ring structure of benzene--which was responsible for the phenomenal growth of organic chemistry, biochemistry, the pharmaceutical industry, medicine, modern chemistry-dependent industry, the production of many commercial household and industrial products, etc. Enrico Fermi, capitalizing on the work of Meitner and Hahn before him, was the developer of the first atomic reactor, which led to both nuclear weapons and the modern nuclear industry--yielding electric power in countries all over the globe, nuclear medicine, and other fissionable-based industrial and medical products. Frederick Banting, working at first in his garage and then at the University of Toronto, isolated and purified--and was thus the discoverer of--insulin, which revolutionized modern medicine (and medical theory) and remains the treatment regimen for millions of people all over the world with diabetes mellitus. Alexander Fleming, working alone and publishing a paper in 1929 showing the killing effect of a strange substance leaching from a penicillium mold in an agar plate--inaugurated the antibiotic era which has saved the lives of millions of people the world over annually. Jonas Salk, publishing the results of his work in the Pittsburgh (Pennsylvania) newspapers because of his distrust for the medical journals and their medical sponsors, was the innovator of the first polio vaccine, which was administered to the children all over the cities and rural areas of America--with the exception of Boston (Massachusetts)--in early 1955. (The doctors of Boston--then considered the "mecca of U. S. medicine"--refused to have the children of Boston immunized with a vaccine they deemed "dangerous.") Later that same year, 1955, Boston suffered the worst polio epidemic ever recorded in the U.S.) The Salk vaccine, followed by the subsequently developed and competitive Sabin vaccine, virtually eliminated poliomyelitis from the face of the earth. In 1957 Dr. Charles Heidelberger developed the anticancer drug 5-FU (5-fluorouracil). Working alone, Heidelberger, a medical biochemist, conceived the idea of substituting a fluorine atom for a hydrogen atom on the nucleic acid base uracil--important to rapidly dividing cancer tissue--with the thought that this new molecule would inhibit cancer cells' ability to multiply and would thus result in a true anticancer effect. Dr. Heidelberger synthesized the molecule 5-FU himself, tested it on cancer-bearing animals himself, then tested it on humans himself. Such was Heidelberger's erudition and creativity, that this work not only advanced chemotherapy signficantly but that 5-FU has remained a mainstay in cancer therapy for over 50 years, used today--by itself and in conjunction with other chemotherapy agents--in a spectrum of human cancer. James Watson, Francis Krick, Rosalind Franklin and Maurice Wilkins, working alone and on both sides of the Atlantic in the 1950s, unlocked the mystery of the double-helix structure of DNA, making possible the first scientific inquiries into the genetic code--and genomes--of various species, including humans, and thus figuring significantly in the important scientific and medical gains to result from this signal discovery. Watson, Krick and Wilkins all received the 1962 Nobel Prize for this work. Franklin unfortunately died (of ovarian cancer) in 1958 and was thus ineligible to be included in this prize, since Nobel Prizes are not awarded posthumously. Biochemist Kary Mullis, working by himself, conceived and developed the polymerase chain reaction (PCR), allowing the amplification of specific DNA sequences, literally opening the door of the entire field of genetics to researchers, scientists, clinicians, pathologists, forensic investigators and others the world over--for which Mullis received the Nobel Prize in 1993. The PCR made possible entry of the science of genetics--and the science of medicine itsef--into the modern era. Luc Montagnier and Robert Gallo, working alone and again on each side of the Atlantic--Montagnier at the Pasteur Institute in Paris, France, and Gallo at the National Cancer Institute in Bethesda, Maryland--were the co-discoverers in 1983 and 1984 of HIV, the presumptive viral cause of AIDS. While Montagnier is generally credited with priority in this discovery, Gallo is regarded as establishing the science which led to this virus' identification and scientific 'portrait.' The discovery and identification of HIV continues to have far-reaching effects on the treatment of millions of AIDS patients worldwide and research on the development of retroviral vaccines in general. Albert Einstein. A German-born theoretical physicist, Einstein is perhaps the ultimate example of an individual working by himself to achieve an extraordinary scientific discovery. Employed as an examiner in a Swiss patent office, personally out of touch with the physics community, in 1905 he published a paper in the German journal, Annals of Physics (Annals der Physik) on the "Special Theory of Relativity," in which he speculated that small amounts of matter could release vast amounts of energy, according to his accompanying equation, E = mc2 . Einstein's monumental discovery changed not only the world of physics and mathematics but has had lasting and unabating ramifications on the worlds of social, scientific, political, ethical--and even religious--thinking and institutions, and continues to have effects on the current world of particle physics (cf. CERN's "Large Hadron Collider").

As many of you know, I , myself, may have reason to understand the contribution that single investigators, working alone, have made to the march of science, because of my discovery of the biochemical (i.e., thermodynamic) mechanism of cancer cachexia, the weight loss and debilitation seen in late-stage cancer, which accounts for 73 percent of all cancer deaths. But I would like to relate an incident which occurred long before then, which was to acquaint me with the importance of but a single individual to the progress of medicine.

Just having received my M.D. degree as a 26-year-old in May 1956, I found myself, two months later, as a post-doctoral research fellow in the Department of Physiological Chemistry at the University of California School of Medicine at Berkeley, as a result of winning a U.S. Public Health Service Post-Doctoral Research Fellowship. In this department where I spent half-time (the other half was spent across the bay in San Francisco, in clinical medicine) my immediate milieu was a sea of Ph.D.s and graduate students who did not exactly appreciate an M.D. in their bailiwick. M.D.s are in general considered a waste of time--and sometimes not too bright--in a basic science department, since most would go on to practice clinical medicine. My boss, and department chairman, renowned biochemist David M. Greenberg, however, was very kindly and encouraged me in scientific directions he thought would be most helpful. In my experimental work I needed a key biochemical, essential to energy metabolism in cancer and normal cells, glyceraldehyde-3-phosphate, G3P for short. The only trouble was none was commercially available. Fine biochemical companies advertised they would custom synthesize it in gram quantities at $800 per gram (a very large sum at that time), but would not guarantee its biological activity. Frustrated, I apprenticed myself to a famed sugar-phosphate biochemist (professor) on the Berkeley campus, who himself had synthesized G3P by a complicated multi-step organic synthesis, including a hydrogenation over palladium, which (if done wrong) might "blow up" the wing of the building in which the hydrogenation apparatus was located. I tried this 10-step organic synthesis, each step starting out with large amounts of material and ending with much smaller amounts. The "synthesis" took me over a month, and when I was finished I ended up with gram quantities of useless "crud." I was sure I could not obtain G3P by this method--no matter who synthesized it. But I thought about the situation. And suddenly it occurred to me that I could start out with a chemical "skeleton" of G3P and in a single, one-step inorganic synthesis--if it worked--I could open up an epoxy bond with common sodium dihydrogen phosphate (NaH2PO4) and obtain more, 100 percent pure, 100 percent biologically active G3P overnight than had ever been seen before. And that's the way it turned out. The sugar-phosphate chemist (full professor) under whom I apprenticed myself for a short time, was not happy to hear of this achievement. But my department chairman, Dr. Greenberg, was and encouraged me to make application for a U.S. patent on it after obtaining the University of California's consent for me to do so and the concurrence of the Surgeon General of the United States. In a short time the price of G3P tumbled from $800 per gram with no guarantee of biological stability or activity to under $20 per gram with full guarantee of biological stability and activity. (And in a few years I did receive a U.S. patent on this process.) In the intervening 50 years since then and now this very same material has sponsored countless research projects, opening a door to the investigation of energy metabolism that had been previously shut tight. And teaching me--even at a young age--about those who would control the politics and purse-strings of biomedical research.

Returning to the AACR advisory on its plans for the SU2C funds, not only is this advisory inaccurate and incorrect, implying that true scientific achievement would be more likely the result of "collaborative" efforts of scientists "working together," rather than the individual efforts of scientists working by themselves, but the advisory stresses the team-approach to be of potentially greater value "than competition." But competition is the heart of creativity. And scientists in competiton with one another have frequently cracked the code of discovery. In the above list of those who were innovators of great discoveries, Salk and Sabin were in competition with one another, each turning out to make great, individual contributions, one an oral vaccine, the other an injectable. Watson, Krick, Franklin and Wilkins were all competitors, racing to see who would be first to decode the mysterious structure of DNA. Gallo and Montagnier contended vigorously with one another, even instituting lawsuits to determine who was truly the discoverer of HIV.

After extolling the "collaborative" approach of the "best and brightest" scientists from "leading institutions" around the world "working together," the AACR advisory also states the following: "A portion of the [SU2C] funds raised will also support innovative, high-risk, high-impact, research grants, many of which will fund talented young investigators who are driving cutting-edge research"--i.e., individual investigators. Are these the truly gifted, young investigators that the MedTruth blog, "Is Bigger Better?" spoke of, those "whose ideas may be 'outside' current cancer concepts--whose scientific thinking may harbor the truly great discoveries to come?" Who magically cannot seem to have their grant applications approved or funded?

"A portion" of the funds going to these "talented young investigators" reminds me of an incident that occurred in the early 1990s. My wife and I were at the annual scientific meetings of the AACR, at which I was to give a paper on the second day of the 4-day meeting. Usually, on the first evening of the conference the AACR holds a "Mixer," open to all registrants of the meetings, the purpose of which is to have the newly elected members--and the newer members in general, including its younger attendees--meet the senior members of the AACR. That was the case in 1957--when I was young attendee at my first AACR conference; at the Mixer I personally met such well known and accomplished scientists as Charles Heidelberger, Sidney Weinhouse, Dean Burk, George Weber and others. But--strangely--at the Mixer in the early 1990s, there were no senior scientists to be seen. The Mixer took place in a very spacious hall, in which there were hundreds of young and unfamiliar-looking individuals milling about--but none of the AACR officers or its more prominent members I had come to know. And in contrast to earlier years when the hall contained all types of refreshment and drinks, at the present Mixer there were only a few stations containing potato chips, and a corner cash-bar where one could purchase cold drinks. But my wife is a "coffee-holic," and she expressed to me, "There's not even a hot cup of coffee here." After saying hello to some old friends we left for the hotel lobby. But our elevator "inadvertently" left us off in a sub-basement. We were about to re-enter the elevator when my wife said, "Wait. I smell coffee!" We found ourselves walking down a corridor full of overhead pipes in the direction from which the smell of coffee was coming. And suddenly trays of hot food appeared from kitchens to the right side of the corridor being wheeled across the hallway to a very large banquet room to the left side of the corridor. Echelons of waiters, all carrying hot foods on enormous trays above their heads were entering this banquet room. And it was obvious the smell of coffee was emanating from this room. My wife and I peeked into this room---filled with large white linen-covered tables, around each of which were ten people, many of whom were in formal attire. About 200 people were seated around these tables. But--suddenly--I recognized one of the faces--then another--then another--and then many! It was a banquet for the "senior" members of the AACR. The mystery was solved. While the younger and newer members of this organization were milling about upstairs at the Mixer, imbibing potato chips and cold beer, my wife and I had stumbled onto an exclusive gathering (unlisted in the Program) for the AACR's senior membership. Later I learned that the AACR itself had paid (from its general funds) for this gastronomic feast.

As alluded to previously, even at a young age my research projects had placed me in a position of an early understanding of the politics and funding of biomedical research. And as illustrated by the above incident of the AACR banquet for its senior membership, the AACR knows how to take care of its own. Over the years I have become acquainted with the words and language--with the catch-phrases and code-expressions--large-scale cancer research organizations use in communications with each other and in their dispatches and communiques to the public. The AACR states "a portion" of the SU2C funds will go to "young investigators"--the very people who find it so difficult to get grants for their ideas. But the advisory doesn't specify how much--how much of the $100 million will go to these frequently gifted individuals. But let us now look at the initial emphasis and predominant verbiage of this advisory. The phrases "most promising research projects," "collaborative efforts," "best and brightest," "leading institutions," "working together," "interdisciplinary and multi-institutional Dream Teams" do not speak of "young investigators" working alone, but of the 'ol' boys' (and girls') network, the senior makeup of large-scale cancer research projects, institutions and organizations who have always received the lion's share of cancer research funds. One can be sure that the predominant (SU2C) funds will go to these well connected, in this case "inter-connected," scientists--as they always have--the very ones who have sponsored the scores of discoveries at the laboratory level waiting to be "translated" to new treatments. The words "a portion" appear in this advisory almost as an afterthought, and clearly imply a minority of the SU2C funds. Even so, the language used indicates that this slim "portion" will support high-risk, high-impact research grants, "many of which"--but not all--"will fund young investigators."

I have an alternative proposal for the AACR. One that holds real hope for progress in the cancer research world--for new discoveries. For new treatments. For new benefits for cancer patients urgently waiting. Let's use these funds--exclusively--for our "talented young investigators." Let's get young investigators--not the older, more "established" scientists, some of whom may in reality be hard-pressed to recognize new ideas--to sit on the peer-review committees. Let's use the $100 million to take all those grant applications from our younger people--that have not been approved, or approved but not funded--and take a second look.

The Stand Up 2 Cancer funds raised could indeed have high impact, not funding collaborative-type research--where the whole is hoped greater than the sum of its parts--but going exclusively to those who are willing to work alone and test the new ideas which have germinated in their young minds.

Friday, August 15, 2008

Cancer and obesity

This blog is a commentary on truth in medicine and thus it would not seem apropos to discuss truth or its lack in terms of cancer and obesity--both exist, both are "true." But perhaps a deeper truth can be found in both topics--one that is not readily apparent: Is there a similarity between the two? Cancer is overtaking heart disease as the number one cause of death in this country. And obesity is rampant, spreading as the number one health hazard both in this country and around the world.

Cancer is said to be more than one disease--to result from many different causes. There is the genetic cause--cancer results from mutated or damaged genes, which can then be transmitted to (inherited in) succeeding generations. Cancer results from abnormal metabolic processes--which MedTruth has already indicated to be the case in cancer cachexia--the weight loss and bodily debilitation seen frequently in advanced disease, which is the major cause of death in cancer (73 percent of all cancer deaths) and treatable by the drug hydrazine sulfate. Cancer results from chronic, poor nutrition. Cancer results from inflammatory tissue reaction. Cancer results from physical trauma (bodily injury). Cancer results from (excess) radiation exposure--medical and 'background.' Cancer results from psychological trauma--following an unexpected breakup in relationships, the loss of a business partner, the death of a loved one. Because cancer has been indicated to result from so many different causes, it has been said to be many different diseases, not one--and thus not prone to a single solution. This consideration has prompted some cancer scientists to express, "There is no silver bullet for cancer," meaning there is no single treatment that will be curative for all types of cancer.

But this doesn't reflect current activity. All cancer centers, all cancer research efforts, all cancer research investigators--are trying to discover a single remedy that will treat all kinds of cancer. Cancer researchers recognize that while many different 'stimuli' will produce cancer, that the disease in various organ systems--no matter what the immediate cause--has certain characteristic similarities and just because we do not know its basic underlying cause does not mean that we will not one day find it and thus come up with a single treatment that will be effective in all cases.

The same may also be the case for obesity. Obesity has many different causes: 'glandular,' metabolic, genetic, calorie balance, nutrition, lifestyle and others. Thus while many people attribute obesity to caloric intake alone, this is clearly not the case. While increased caloric intake must necessarily--from a thermodynamic point of view--accompany most cases of obesity, obesity can result in the face of "normal" or sometimes even "subnormal" caloric intake. Like cancer, obesity seems to be many 'diseases'--to have many causes. But like cancer, can it also have a common, underlying cause--one that is pertinent to all cases--but one which we have simply not yet discovered?

In geometry there is a theorem: things equal to the same thing are equal to each other. If cancer, which is said to result from many causes, has in reality a single, underlying cause--which we have not yet identified--can obesity, which is said also to result from many causes--in reality also have a single, underlying cause--which, again, we have simply failed to identify?

Much effort is now being expended to find a single cause for cancer. Hardly any effort is being expended to see whether indeed this "twin" condition under discussion may also have a unifying theme. Therefore this blog will examine obesity--to see whether a deeper truth in medicine may exist to account for this growing world problem.

It is expected that the 'soluton' to cancer will involve physical--biochemical, biological--mechanisms that will account for tumor growth, for abnormal tissue formation and invasion into normal bodily tissues and glandular elements, especially in view of this disease's multiple manifestations. Obesity, too, has multiple manifestations--'causes'--but because obesity also must necessarily involve 'choice'--the excess intake of calories in most cases--a 'solution' to this problem may well reside in, and therefore yield to an examination of--the psychological realm.

A first question to arise is, Do people who are overweight know they're overweight? By "people" is meant the majority of people. We cannot ever achieve 100 percent when we talk of people who may carry excessive weight--but we can speak of at least 70 percent to 95 percent. Do people who are overweight actually know they're overweight? The answer must be a resounding 'yes!' The mirror tells them they're overweight. Social situations tell them they're overweight. Their own eyes tell them they're overweight. This question in no way addresses whether they care they're overweight--merely the knowledge that they know they're overweight.

Do people know that being overweight is associated with a multitude of health problems--high blood pressure, diabetes, heart disease, among many others--which can result in severe illness and/or severely shorten life expectancy? Television broadcasts, frequent articles in the print media, visits to their doctors' offices emphasize these life-limiting complications at every turn. Therefore the answer to this question is that people who are overweight know--are frequently informed--that being overweight is not good for them.

Thus people who are overweight know they are overweight and that being overweight is destructive of their health. That is, being overweight is a self-destrutive election on their part.

Do people who are overweight like being overweight? This is not a simple question, for some maintain that people basically do what they like to do--that a person who is overweight likes to be overweight. But with the large numbers of dieters striving to lose weight, the nationwide diet support groups, the diet foods on grocery and specialty-shop shelves, even the in-hospital diet programs, there is no doubt that the vast majority, even those who may "like" being overweight--do NOT like being overweight. Thus whether a 'psychological ambivalence' to this queston seems to exist is immaterial, in the face of the vast numbers of dieters seeking to lose weight.

Another aspect to this same question is, Do people get pleasure eating?

People must get pleasure in life. In their activities. In their strivings. In sexual expression. In their interpersonal relations. Even in masochistic outlets--in physical and psychological harm done to them by others. No matter what the orientation or circumstance--the hermit immersed in the psychological cave of darkness, the child trapped in the vise of familial poverty, the socially advantaged whose overindulgence of appetites has led to spiritual dissolution--the inner urge for pleasure remains as a rock-bottom part of the human condition.

I often have lunch at a cavernous restaurant--dozens of substantial tables and chairs, many booths--that serves good food in quantity and at fair prices. From a table in the middle of the restaurant one can view the front glass doors--which at that time of day hardly ever have time to close completely, due to the plethora of diners entering and exiting. Making their way into this restaurant at meal times is a cross-section of humanity--the old (some in wheelchairs), the young, those in-between--in business suits and jackets, in dresses and skirts, in leisure clothes, many in shorts and flimsy tops or sweatshirts, weather permitting. But what is outstanding about the mass of humanity entering or exiting is their weight. Many are carrying an extra twenty-five to fifty pounds. Some, more than a few, are frankly--frighteningly--obese. The men are sheltering up to 100 pounds or more above their belt lines, some with their abdomens hanging below their waists. The women are storing excess weight in all parts of their bodies, their legs, arms and other parts of their anatomy stretched by layers of 'cellulite.' Children, whose outlines appear to be puffed up like balloons, follow in their family's footsteps. In many instances the adults are so obese that they tip while walking or actually use assistive devices--canes--to walk. Observations inform us immediately that this overweight is not 'gender-specific'--men, women (unfortunately many children) are caught up equally in this 'epidemic.' If one bothers to do an informal 'count' on those entering the restaurant, it seems that two out of three are carrying excessive amounts of weight--and half of those (one out of three) are frankly obese.

When those overweight people are seated at tables and their meals delivered, in many instances their plates are laden with food, and are cleaned totally--even the children's.

Do people get pleasure eating? Yes they do.

At this juncture it is apparent that people who are overweight know they are overweight, know that being overweight is destructive of their health--will make then ill, prevent them from full participation in life, shorten their lives--that being overweight is a self-destructive choice on their part. And that people gain pleasure in eating. While at first glance it may be thought that pleasure gained in eating offsets the destructive elements of overweight, it actually reinforces them, acting as the 'mortar' that helps keep the edifice of self-destructiveness in place. One can see at a glance that despite diet programs and diet foods and diet support groups and media promotion of dietary success stories, these measures are doomed to failure, for they do not address the fundamental election of self-destruction inherent in overweight. That is, despite knowing they're overweight and knowing that overweight will substantially cripple their physical and psychological lives, despite the existence of self-help groups to reverse and rectify this condition, people still choose to maintain this mode of destroying the self.

Why?

Is there a relation between overweight and self-esteem? A connection? Can people with self-esteem be overweight? How can people who 'admire' the self carry excess weight to the point of bodily distortion? How can people who 'admire' the self engage in a 'process' that leads to destruction of the self?

But that is too easy. Because 'self-esteem' can be based on both physical and psychological considerations. Can people who are 'pleased' with their psychological development, intellectual and artistic, ignore the destructive process they are imposing on their bodies by overweight, processes that will shorten their life spans--and still remain 'pleased' with themselves?

What determines self-esteem? Self-esteem involves contemplation of the self--our overall raison d'etre--our 'reason' for being in this world. We all think about this--both consciously and unconsciously--continuously. From childhood into adulthood. Why have we come into life? Is there a purpose in life? Do we have an individual purpose in life? Are people endowed with purpose?

It is commonplace to see the smiles and the expression of joy on even the smallest of infants--as they contemplate their surroundings, their parents and/or caregivers. This joy expressed by children--is the joy to be alive. The realization--amorphous at first, more finite with the passing years--that life is the greatest gift of all. That to each of us is given a "sense" that our individual life--self--is "special." That individual life is special. That this sense of "specialness" makes us what we are. That as long as we retain it, it will act as our internal gyroscope and will "validate" the life we have been given. The early nineteenth century landscape painter (especially of the Hudson River Valley), Thomas Cole, in his four-part masterpiece, The Voyage of Life (Munson-Williams Proctor Museum, Utica, New York), allegorizes that each life has 'magic' and in the second panel of his four-part painting he depicts "youth" reaching out to attain the 'magic' of life. This magic is none other than our "purpose" in life. Our individual purpose. That as long as we continue to develop the self within us--our hopes, dreams, aspirations--the individual magic with which we are endowed will be retained. (This development of the self is to be distinguished from "selfishness"--the aggrandizement of the individual over other individuals for the purpose of harnessing their power and wealth.)

But we have given up living for our selves--living to express our individual purpose. Living to fulfill our "contract" with life.

Instead we are increasingly being told that our "purpose" is to live for someone else. The purpose of the self--is to serve other people's selves. Whether the Communistic theme or the altruistic theme, we have been duped into giving up our integrity, our "specialness," our individual "purpose" in life.

Once we have done that, anything goes--our inner 'gyroscope' is gone. We have closed the door to preservation of the self. Self-destruction, in all its forms, sets in. And we are powerless to overcome it, for it is, in more instances than not, "frozen" in our unconscious.

We become adrift. We are afloat with the tide. We are in search of "finding ourselves." But the 'self'--our inner "essence"--is missing. It is gone. We have given it away. We know that overweight is destructive to our health, but we seem powerless to do anything about it. And the more we seem to try, the greater the problem becomes.

Can the loss of purpose be reversed? Yes, it can.

There are generally two ways to change our lives--redemption and reclamation.

When we perceive we have been on a wrong track, many times we try to do things that will "make up" for our wrong moves. We try to "redeem" our shortcomings, or what we perceive "must be" a defect in our make-up. Very often we do "volunteer" work, something we hope will result in the public, or private, good--as it usually does. Or church work, or temple work--the promotion of religious values. Join organizations for the disadvantaged, for the promotion of world peace, etc. But these redemptive measures--while serving potentially very constructive aims in society--cannot restore the 'magic' or "specialness" to the personality that loss of purpose has exacted.

Reclamation, however, can. We can "reclaim" at least part of our lost sense of purpose by revisiting old hopes and dreams and aspirations long ago abandoned (because of their anxiety content), long ago given up. But still beckoning to us. Still "open." Still sometimes flitting into our consciousness.

We can revisit one of these "open" longings--"scary" as it might be to do so. We can pursue a direction long ago cast aside but promising soul-deep satisfaction. Not for "mom and dad." Not for "hubby or wife." Not for the sake of our children--or of society. Not for the "greater good." But for ourselves.

We can confront those privately cherished, long given up goals one at a time, and if we work hard enough, then we will find we are successful in the 'reconstruction of the self,' and our need for self-destruction will diminish. And if we are overweight, chances are our overweight will diminish, too, without any specific measures taken.

Once we have been successful in "reclaiming" a single 'tableau' in our life that we had let slip by, it will be easier turning to another, then another. If we are successful in our efforts to face up to the poor decisions we have made in life--the ones that have markedly abridged what we have always known to be our inborn potential--the door to preservation of the self will once again open, and self-destruction, in all its manifestations--including overweight--will be chased away.

Regarding cancer, it will not be easy finding its single underlying molecular cause or causes, but once we do, we have a real hope of conquering the disease.

Regarding obesity, if indeed a loss of 'self' or 'purpose' is the basic 'cause' underlying this growing, worldwide illness, it, too, can be conquered. It will require courage, discipline and determination.

Tuesday, June 17, 2008

Quackery

Quackery is defined as the fraudulent pretension to medical skill, in which the practitioner of quackery, often referred to as a charlatan or imposter or quack, knowingly gives or prescribes inaccurate or inappropriate or false or deceptive medical information or treatment, for the purpose of making money. The quack often takes advantage of the medical ignorance of his "patients" and of the confidence they have come to build up in him.

The term quackery can apply to a host of different situations, but there is an overall definition which applies to all: namely, that quackery is the practice of intentionally dispensing false medical information to those seriously ill, or not ill at all, for the purpose of acquring wealth.

There is no doubt that the practitioner of quackery must be regarded as a reprehensible human being in today's society--despicable, loathsome, odious, repugnant--a vampire, eager to squeeze the last dollar from a patient's illness or his/her yearnings for better health.

However, there are two types of quackery: authorized and unauthorized. It is the unauthorized kind that we commonly talk about when we speak of quackery: the snake-oil salesman, the purveyor of fake nostrums that purportedly cure all ailments from "dementia" to sexual inadequacies. Illustrating this kind of quackery is Pope Brock's new book Charlatan (Crown Books, 2008), detailing the case of John Brinkley who during the first half of the 20th century established clinics across America for surgically implanting goat's testicles in men to restore "sexual vigor." Brinkley, who received a medical degree, became enormously wealthy, dying in 1942, before he could be brought to trial on charges of mail-fraud.

Today there are legitimate, well-credentialed doctors who act as "quackbusters." These doctors attempt to alert society to the dangers of what they perceive as "quackery" and who they perceive as "quacks." However, the targets of these "quackbusters" often turn out to be legitimate, well-credentialed physicians or scientists themselves who have come up with unconventional or unpopular (to the medical establishment) treatments. Illustrative of these quackbusters was the late, well-known physician (and attorney) Victor Herbert, M.D., J.D. Herbert, often declaiming against the use of vitamin treaments as part of conventional medical therapy--he called this "quackery"--was himself the target of lawsuits alleging incompetence, malfeasance and professional misconduct (Racketeering in Medicine, J. Carter, 1993).

As detailed in a front page article from a recent Sunday edition of The New York Times, "Cancer doctors are pocketing hundreds of millions of dollars--often the majority of their practice revenue...by selling drugs to patients--a practice that almost no other doctors follow....Typically oncologists [cancer doctors] buy chemotherapy drugs themselves, often at prices discounted by the drug manufacturers trying to sell more of their products, and then administer them intravenously to patients in their offices. They can make huge sums...from the difference between what they pay for the drugs and what they charge for them, a practice known as the 'chemotherapy concession'....The practice creates a conflict of interest for these doctors, who must help patients decide whether to undergo or continue chemotherapy if it is not proving to be effective....The [chemotherapy] concession [i.e., the profit motive] may lead some doctors to recommend chemotherapy when patients may not benefit. In a 2001 study of cancer patients in Massachusetts a team of [National Institutes of Health] researchers found that a third of those patients [in the study] received chemotherapy in the last six months of their lives. even when their cancers were considered unresponsive to chemotherapy" (emphasis added). Some doctors argue that their motivations for this practice are not money, but solely "to provide patients a chance, no matter how slim, of living longer or suffering less." But use of chemotherapy in unresponsive patients is known to frequently result not in longer life or suffering less, but in shorter life and greater suffering and sometimes abrupt death. " 'All the evidence suggests that doctors do respond to money,' " Dr. Susan D. Goold, a professor at the University of Michigan School of Medicine states in the Times article.

But treating hapless (late stage, unresponsive) patients with known, useless therapy--and gaining wealth therefrom (the chemotherapy concession)--isn't that the exact definition of quackery? To the extent that cancer doctors recommend that advanced, refractory patients with only a short time to live undergo or continue ineffective chemotherapy (one-third of even study patients)--with the profit motive in mind--these doctors cannot be told from their more aggressive and obvious "brethren" selling ineffective nostrums in order to gain wealth. Nor is this practice, filling the exact definition of quackery, without harm. Frequently enough cytotoxic chemotherapy given to patients with but a short time to live results in their untimely deaths. In the United States alone there are thousands of authenticated chemotherapy deaths annually. (One of these was Jackie Kennedy, wife of the late president John F. Kennedy, who reportedly received chemotherapy in the very advanced states of lymphoma, dying shortly--within days--thereafter.)

Thus there is a second type of quackery--one that I term 'authorized' quackery. Less recognizable and more socially accepted than the 'flim-flammery' of the nostrum peddler, it is every bit as diabolical. And that is the practice by physicians--many upstanding and well-credentialed--of recommending and instituting treatments known to be useless and ineffective in certain cases, but for which the physician knows he will be well compensated. He imparts 'confidence' to the patient, 'hope' to the family when he knows that the only certain outcome--his true motivation for recommending the treatment--will be a gain in his own wealth. We don't call that quackery. We call it 'courage.' We call it 'heroic.' But it is quackery.

Are there other types of physician-induced medical treatments--where the treatment is useless, ineffective or not necessary, and not without harm--that are done with only a fee in mind? To name a few: hysterectomies, physician-run vitamin mills ("every patient who comes through my door gets a B-12 shot"), tonsillectomies, mastectomies ("they took my breast--but thank God it wasn't cancer"), breast augmentations, lobectomies, prostatectomy "factories" ("I'm moving my urology practice to Florida--where there are lots of old men with money"). The list is endless. For there is hardly a medical or surgical procedure that is not infrequently recommended and performed with only a fee in mind.

The question is: Which is quantitatively greater in our society? The occasional hawker of fake nostrums? Or the purveyor of unnecessary, useless, ineffective, sometimes harmful medical or surgical procedures? Which causes more economic chaos, more disappointment, more personal heartache? The easily identifiable snake-oil salesman? Or the pharmaceutical or medical pitchman invading the cavities of our minds and our pocketbooks? The 'unauthorized,' unlicensed quack? Or the licensed 'pillar of society' knowingly recommending and performing useless, unnecessary procedures for the sake of accumulating wealth? I think you will find that the John Brinkleys of today's society are a drop in the bucket compared to the 'authorized' medical fraud perpetrated by elements of our medical establishment.

For the above reason it is almost preposterous for a doctor to hang a sign on himself as an "expert" exposing the "quackery" of "others" without calling attention to the medical fakery of fellow physicians.

And it is almost obscene for the professional "quackbuster" to single out as "quacks" those who are the innovators of new treatments--new directions in medical research and management--almost anything that changes/upsets the medical status quo. Historically scientists and physicians who are the heroes of tomorrow's medicine are routinely labeled as "quacks" in the early part of their careers.

Those who don the garb of professional "quackbusters" are in reality dangerous elements to our society who, under the 'window dressing' of protectors of society are in actuality more frequently the agents of unspeakable harm to medical progress, managing in their usually long careers to clip the wings of many birds before they can fly.

My advice is to run from these beastly individuals. From those who have taken their careers in medicine--their many long years of arduous study and training--to become little more than beacons exposing fraud from without the medical profession without beaming their lights on the medical profession itself.

Even books like Charlatan, interesting and historic as they are, serve to divert attention away from the quantitaively greater "quackery" that confronts society today--not the outlandish implantation of goat testicles in human beings to restore their sexual vigor, but that accomplished every day in the recommendation and performance of thousands of useless, unnecessary, ineffective medical procedures by avaricious, money-obsessed individuals within the medical profession itself.