surviveCANCER Foundation

There is always a swirling controversy when talking about over the counter supplements either in lieu of chemotherapy or in support of chemo. Oncologists, the AMA, and the FDA harass and harangue about using them. Yet, here is a note published in England on March 9, 2006 about a study done at our own NATIONAL INSTITUTES OF HEALTH in Bethesda, Maryland. Strange how I could not find anything about it locally in the papers or normal medical journals.

Following that is an article from Life Extension Foundation dealing with another study as reported again by NIH. This time, the article showed up in a Canadian publication.

I guess what is most disturbing to me is that nobody in the USA seems to publish articles on things we do in the USA that appear to run counter to the big business called the health industry. You have to go outside our country to find out what the government is doing. Is there something wrong with this picture? Why can’t we see things like this jumping from the headlines in newspapers all across the nation?

For 50 years doctors have been “on the edge” of a breakthrough in fighting cancer. The medical establishment is a 2.3 TRILLION DOLLAR ($2,300,000,000) a year business. What would happen if you could stop cancer for $200 or even $1000 in treatment rather than the typical $60,000 for just one full round of chemotherapy that often times is repeated again and again and again?

Of course, healing patients is not the issue, is it?

That really sounds like a mercenary statement, but it is meant to. If you total up what was supposed to be done to me with the removal of both kidneys, placed on dialysis with chemo and radiation, plus (if I lived long enough) a kidney transplant, the whole bill would have run in excess of $1.3 million dollars in 2005 money. I stopped my cancer with less than $5,000 worth of supplements and a dietary change. It is now apparent to me that I could have done it most likely for less than $500.

Following conventional medical wisdom, I would, at this very moment, be on a dialysis machine every other day. My insurance company would be shelling out hundreds of thousands of dollars to keep me alive. I would have great discomfort and potentially be waiting for yet another surgery a few years down the road to replace a kidney, provided I lived long enough.

I am not saying that the ability to do this surgery is not a viable consideration. Had my kidneys quit working or I had been in an accident where they were damaged beyond salvage, that surgery and ultimate replacement would be most welcome and I would not hesitate to avail myself of its offering. Yet, when both kidneys were working fine, albeit extremely taxed because of the tumors, and I could keep them functioning and live a relatively normal life as long as I do not push them too hard, what is the logic that dictates I should endure what had been planned for me?

I am not saying that chemo and radiation do not have a place in the treatment of cancer. Far from it. What I am saying is that there are legitimate options out there. Some of them, such as intravenous high dose vitamin C therapy have even been tested and written up by our own government and still they are not considered viable choices for a cancer victim to use. WHY IS THAT? You need to write your legislators in both congress and the senate. Ask them these questions. Ask them why you cannot readily be told about things our own government has tested and found to work. Ask them why you are being held captive to a medical establishment that values money over life. More importantly, ask them why there are no clinical trials being done to find out what supplements of any kind can be used in conjunction with chemotherapy and radiation to help individuals through the treatment process. We need to push our legislators to do SOMETHING other than be controlled by the pharmaceutical industry.

Hand in hand with the issue of supplements, chemotherapy, and radiation is the consideration that most success with defeating cancer by conventional means comes with stage 1 or 2 cancers. In the 50+ years that there has been a concerted effort to use chemotherapy to defeat cancer, there has been virtually no advancement in responsiveness to late stage cancer advancement. Stage 3 and stage 4 cancers of any type have “cure” rates under 10%. Frequently they are under 5% and that is abysmal considering the hundreds of billions of dollars spent on research.

NOTE: In the second article from LEF, there is some interesting information published by MD’s who have researched the use of antioxidants in conjunction with chemotherapy and have shown that it does help not hinder the treatment of cancer. Again, this flies in the face of conventional medical wisdom.

If you are planning chemo or radiation, I invite you to look at a protocol we set up to help your body through these tough times. It is obviously something that should be discussed with your medical professional, but be prepared to more than likely be told it will not work even though there is proof that it will help. How you choose to help yourself is your own business, but you are the one ultimately responsible for keeping yourself alive. Use every tool you can get your hands on. Do not limit yourself because someone else is trying to dictate choices.

After the second article are a number of research papers that you should take time to look up. These deal with supplements in use with conventional medicine for cancer control. Don’t just take my word for it, here is some basic information for you to follow up on. If this spurs you to further research, there are over 3,000 scientifically published documents I have personally seen between WEBMD and PUBMED that deal with supplements and cancer. They report the success as well as the failure. Nobody is hiding anything except our government and the established medical community. There needs to be public awareness of options. There needs to be a desire on the part of people to help themselves and take their health into their own hands. Doctors are a help, a tool for you, but you are the one responsible for maintaining your health. If you dig further, there are at least another 20,000 scientific/medical reports on natural compounds that have been tested for cancer control. I simply have not had time to look at everything I know is there.

ARTICLE 1:
March 9, 2006

VITAMIN C: So it can kill cancer, just as the man said

Whisper it in case you wake the pharmaceuticals, but Linus Pauling was
right all along. Very high doses of vitamin C can kill cancer, just
as the Nobel prize-winning chemist and physicist suggested.

Scientists at the National Institutes of Health in Bethesda have
demonstrated the theory in laboratory tests. They used very doses of
the vitamin, in its ascorbate form, on nine cultures of cancer cells.

Only half the cells survived in five of the cell groups, and growth of
lymphoma cells was 'reduced by at least 99 per cent". In other words,
the vitamin killed the cancer cells, and stopped their regrowth.

The therapy also worked with my own mother, whose end-stage breast
cancer was completely reversed by intravenous vitamin C.

But while medicine remains a front for the profit-crazy pharmaceuticals, none of this ever sees the light of day, and cancer sufferers continueto be given chemotherapy that debilitates and kills.

(Source: Proceedings of the National Academy of Sciences).

ARTICLE 2:
The March 28, 2006 issue of the Canadian Medical Journal, reported three cases of individuals with terminal cancer who experienced unexpectedly long survival times following the administration of high dose intravenous vitamin C.
Mark Levine and colleagues from the National Institutes of Health in Bethesda, Maryland examined the details of three advanced cancer cases in accordance with National Cancer Institute Best Case Series guidelines. Patient 1 was a 51 year old woman with metastasized kidney cancer who declined conventional cancer therapy and received 65 grams intravenous vitamin C twice per week for ten months, along with several other nutritional supplements such as N-acetylcysteine and thymus protein extract. Patient 2 was a 49 year old man with advanced bladder cancer who also refused chemotherapy and radiation, and who received 30 grams vitamin C twice weekly for three months, followed by 30 grams every one to two months for four years. Patient 3, a woman with stage III diffuse B-cell lymphoma, underwent 5 weeks of radiation but declined chemotherapy and opted for 15 grams vitamin C two times per week for two months, followed by once per week for seven months, then once every two to three months for one year. Patients 2 and 3 also combined a number of nutritional supplements with their treatment.
Although patient 1 died of smoking-related lung cancer several years after her initial treatment while the kidney cancer was in complete remission, patients 2 and 3 remain in good health with no symptoms of recurrence.
In their introduction to the case studies, the authors suggest that the failure of high dose vitamin C to effectively treat cancer in trials conducted at the Mayo Clinic could have been due to the oral route of administration which can only elevate plasma levels of the vitamin to a maximum of 220 micromoles per liter, while intravenous administration can raise levels as high as 14,000 micromoles per liter. They note that concentrations of 1,000 to 5,000 micromoles per liter have been shown to be selectively toxic to tumor cells in culture studies. Additionally, studies conducted several decades ago by Linus Pauling and Ewan Cameron which used high doses of both oral and intravenous vitamin C reported success against terminal cancer.
Concerning the current case history review, the authors commented that “most previous case reports lacked independent pathologic confirmation of the tumour and did not follow the NCI Best Case Series guidelines, which makes their interpretation difficult.” They conclude, “In light of recent clinical pharmacokinetic findings and in vitro evidence of anti-tumour mechanisms, these case reports indicate that the role of high-dose intravenous vitamin C therapy in cancer treatment should be reassessed.”
Protocol
Cancer supplements
Although there are hundreds of published studies showing that the ingestion of certain nutrients may reduce cancer risk, relatively few investigate the effects of dietary supplement intake by those already stricken with cancer. This paucity of data has enabled mainstream oncologists to speculate that certain dietary supplements might protect cancer cells from apoptosis (programmed cell death). The assertion made by some oncologists is that there may be a risk when cancer patients take certain dietary supplements.
Abram Hoffer , MD. PhD, contends that the concept of antioxidants decreasing the efficacy of chemotherapy is conveyed more and more by orthodox oncologists. It is, in fact, speculated that the number of oncologists opposed to patients taking antioxidants while receiving chemotherapy may be as high as 75%.
Dr. Hoffer adds that he has treated more than 1100 cancer patients with high doses of vitamin C (most of whom were concurrently receiving chemotherapy) (Hoffer et al. 1993a; Hoffer et al. 1993b; Hoffer 1994; Hoffer 1996). Upon examining health histories, Hoffer found that the mean difference in prolongation of life was heavily in favor of the use of vitamins. In the first Hoffer/Pauling series published, patients on the Hoffer program lived 10-20 times longer than patients not receiving vitamin C.
Critics argue that antioxidant supplements should not be used while treating cancer patients with conventional therapy because they would protect cancer cells against free radicals that are produced by most anticancer agents (Labriola et al. 1999).
One way of approaching this dilemma is to observe the distinct differences of low-dose compared to high-dose antioxidants on cancer cells (Prasad et al. 1998; 1999b). Antioxidants such as vitamin A (and its drug analogs), vitamin E (tocopheryl succinate), vitamin C, and certain carotenoids, when used in high doses individually, have been shown to induce cell differentiation, growth inhibition, and apoptosis in rodent and human cancer cells in vitro and in vivo (Kline et al. 1995; Cole et al. 1997; Prasad et al. 1998; 1999b).
http://www.lef.org/protocols/prtcl-153.shtml

Below are a list of research papers that should be reviewed. This relatively short selection is indicative of what is found, good and bad. It is your life and you need research everything thoroughly before making a decision. Here is a starting point on this topic.

1. Richardson MA, Sanders T, Palmer JL, et al. Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol 2000;1:2505-14.
2. Angell M, Kassirer JP. Alternative medicine — the risks of untested and unregulated remedies. N Engl J Med 1998;339:839-41.[Free Full Text]
3. Padayatty SJ, Riordan HD, Hewitt SM, et al. Intravenously administered vitamin C as cancer therapy: three cases. CMAJ 2006;174(7):937-42.[CrossRef]
4. Oliver RT, Nethersell AB, Bottomley JM. Unexplained spontaneous regression and alpha-interferon as treatment for metastatic renal carcinoma. Br J Urol 1989;63:128-31.[Medline]
5. Herr HW. Conservative management of muscle-infiltrating bladder cancer: prospective experience. J Urol 1987;138:1162-3.[Medline]
6. Kaminski MS, Coleman CN, Colby TV, et al. Factors predicting survival in adults with stage I and II large-cell lymphoma treated with primary radiation therapy. Ann Intern Med 1986;104:747-56.[Medline]
7. Creagan ET, Moertel CG, O'Fallon JR, et al. Failure of high-dose vitamin C (ascorbic acid) therapy to benefit patients with advanced cancer. A controlled trial. N Engl J Med 1979;301:687-90.[Abstract]
8. Moertel CG, Fleming TR, Creagan ET, et al. High-dose vitamin C versus placebo in the treatment of patients with advanced cancer who have had no prior chemotherapy. A randomized double-blind comparison. N Engl J Med 1985;312:137-41.[Abstract]
9. Chen Q, Espey MG, Krishna MC, et al. Pharmacologic ascorbic acid concentrations selectively kill cancer cells: Action as a pro-drug to deliver hydrogen peroxide to tissues. Proc Natl Acad Sci U S A 2005;102:13604-9.[Abstract/Free Full Text]
10. Engel R, Evens AM. Oxidative stress and apoptosis: a new treatment paradigm in cancer. Front Biosci 2006;11:300-12.[Medline]
11. McEligot AJ, Yang S, Meyskens FL Jr. Redox regulation by intrinsic species and extrinsic nutrients in normal and cancer cells. Annu Rev Nutr 2005;25:261-95.[CrossRef][Medline]
12. Diaz Z, Colombo M, Mann KK, et al. Trolox selectively enhances arsenic-mediated oxidative stress and apoptosis in APL and other malignant cell lines. Blood 2005;105:1237-45.[Abstract/Free Full Text]
13. www.iconmag.co.uk/alternatives_to_chemotherapy.htm (Dove Clinic)

14. www.mnwelldir.org/docs/cancer1/altthrpy.htm
http://healthy.net/scr/news.asp?Id=7915 (NIH)
15. www.lef.org/news/LefDailyNews.htm?NewsID=2705&Section=VITAMINS&source=DHB_05 0914&key=Body+ContinueReading

16. http://doctoryourself.com/cancer_hoffer.html
17. www.doctoryourself.com/riordan1.html
18. www.aidan-az.com/articles/vitaminc.pdf (Riordans)

19. www.annieappleseedproject.org/amcolforadin1.html (H. Riordan, 2003)
Riordan, Hugh D. (1997). High-Dose IV Ascorbate as a Cytotoxic
Chemotherapeutic Agent. ACAM 1997 Spring Conference, Tampa, FL. (audiotape)
20. www.newmediaexplorer.org/chris (click "Articles by Date" and 7/21/04 Vit. C heading) http://cancerdecisions.com/071804.html

21. Cameron E. Protocol for the use of vitamin C in the treatment of cancer.
Med Hypotheses. 1991 Nov;36(3):190-4. Review.
PMID: 1787808 [PubMed - indexed for MEDLINE]

22. Riordan HD, Hunninghake RB, Riordan NH, Jackson JJ, Meng X, Taylor P,Casciari JJ, Gonzalez MJ, Miranda-Massari JR, Mora EM, Rosario N, Rivera A. Intravenous ascorbic acid: protocol for its application and use.
P R Health Sci J. 2003 Sep;22(3):287-90.

23. PMID: 14619456 [PubMed - indexed for MEDLINE]
Padayatty SJ, Sun H, Wang Y, Riordan HD, Hewitt SM, Katz A, Wesley RA, Levine M. Vitamin C pharmacokinetics: implications for oral and intravenoususe. Ann Intern Med. 2004 Apr 6;140(7):533-7.
PMID: 15068981 [PubMed - indexed for MEDLINE]

24. Jaffey M. Vitamin C and cancer: examination of the Vale of Leven trial
results using broad inductive reasoning. Med Hypotheses. 1982 Jan;8(1):49-84. PMID: 7038410 [PubMed - indexed for MEDLINE]

25. Riordan HD, Riordan NH, Jackson JA, Casciari JJ, Hunninghake R, Gonzalez MJ, Mora EM, Miranda-Massari JR, Rosario N, Rivera A. Intravenous vitamin C as a chemotherapy agent: a report on clinical cases. P R Health Sci J. 2004 Jun;23(2):115-8.
PMID: 15377059 [PubMed - indexed for MEDLINE]

26. Head KA. Ascorbic acid in the prevention and treatment of cancer.
Altern Med Rev. 1998 Jun;3(3):174-86. Review.
PMID: 9630735 [PubMed - indexed for MEDLINE]

27. Padayatty SJ, Levine M. Reevaluation of ascorbate in cancer treatment:
emerging evidence, open minds and serendipity.
J Am Coll Nutr. 2000 Aug;19(4):423-5. PMID: 10963459 [PubMed - indexed for MEDLINE]

28. Cameron E, Pauling L. Supplemental ascorbate in the supportive treatment of cancer: Prolongation of survival times in terminal human cancer. Proc Natl Acad Sci U S A. 1976 Oct;73(10):3685-9.
PMID: 1068480 [PubMed - indexed for MEDLINE]


29. Cameron E, Campbell A. Innovation vs. quality control: an 'unpublishable' clinical trial of supplemental ascorbate in incurable cancer. Med Hypotheses. 1991 Nov;36(3):185-9.
PMID: 1787807 [PubMed - indexed for MEDLINE]


30. Gonin JM, Nguyen H, Gonin R, Sarna A, Michels A, Masri-Imad F, Bommareddy G, Chassaing C, Wainer I, Loya A, Cary D, Barker LF, Assefi A, Greenspan R, Mahoney D, Wilcox CS. Ascorbic acid (Vitamin C) in the treatment of cancer. J Med Soc N J. 1980 Jan;77(1):49. No abstract available. PMID: 6928213 [PubMed - indexed for MEDLINE]


31. Pavlovic S, Fraser R. Orthomolecular oncology: a mechanistic view of
intravenous ascorbate's chemotherapeutic activity.
P R Health Sci J. 2002 Mar;21(1):39-41. Review.
PMID: 12013679 [PubMed - indexed for MEDLINE]


32. "[For] full text copies of the following articles, please email
[ken@hkschueler.com]"
Keith Block,Md Mark Mead, MS. "Vitamin C in Alternative Cancer Treatment: Historical Background". Integrative Cancer Therapies 2(2);2003 pp 147-154.
Padayatty S, Hugh D. Riordan, He Sun. Vitamin C Pharmacokinetics:
Implications for Oral and Intravenous Use". Annals of Internal Medicine
2004; 140: 533-537
Tamayo C, Richardson MA "Vitamin C as cancer treatment". Alternative
Therapy in Health & Medicine, 2003 May-Jun;9(3):94-101.
Padayatty S, "Reevaluation of Ascorbate in Cancer Treatment: Emerging
evidence, Open Minds and Serendipity," Journal of the American College of Nutrition Vol.19,No.4, 423-425 (2000).

Senators Kennedy, Harkin, Hatch, and Durbin are reintroducing a bill defeated twice before that would require the mandatory reporting by dietary supplement companies of adverse event reports they receive. The bill contains many features that will give FDA vast new powers over supplement companies without effecting any change that will improve consumer safety. Indeed, the bill's features will create new delays in discovering actual adverse events and will disable first responders needed to take swift action against acts of terrorism. My criticisms of the bill are contained in the attached document. Please contact your member of Congress and urge opposition to the mandatory AER reporting bill about to be introduced in the United States Senate.
________________________________

SUMMARY OF PROBLEMS WITH MANDATORY AER BILL

Misdirection of Complaints from Local Responders to Federal Authorities; Terrorism Risk Increased. The bill directs consumers to complain to dietary supplement manufacturers and retailers rather than to local physicians and health authorities if they believe they have experienced a serious adverse event from ingesting a dietary supplement. The bill pre-empts local systems, including those of poison control centers, to the extent that they are not identical to the bill directing reporting to supplement manufacturers and retailers and then, by them, to the FDA. The combined effect of these measures is to direct consumers who are injured away from health authorities who need the information not only to respond to the medical needs of the person harmed but also to assess whether the harms are due to causal fact! ors other than the ingredients in the supplement, including causal factors that may reveal acts of terrorism. By directing consumers to complain to supplement manufacturers and retailers and, in turn, to have those entities send the complaints along to the FDA in Washington, the bill removes information from local responders that would otherwise aid them in determining ultimate causes. It will then tend to delay response. Rapid response is indispensable, particularly in dealing with terrorist acts (such as injection of a toxic chemical into dietary supplement containers on store shelves).

Fox in Charge of the Hen House Effect. Ironically, the bill depends upon those who may be responsible for adulteration to report adverse effects to the FDA. In instances of harm stemming from purposeful acts of adulteration, it is unlikely that one who violates the law by selling tainted goods will report the law violation by sending the government the complaints received. By directing complaints away from physicians and local authorities, this system will diminish the extent to which serious adverse events caused by intentional wrongdoing will be discovered.

No Safeguards Against FDA Abuse. One of the principal reasons why Congress passed the DSHEA was to arrest instances of abuse of law and process by the FDA due to its historic bias against dietary supplement companies. The bill invites FDA to investigate supplement companies based on unverified complaints of injury. There are no limits on the investigatory process. As we know from experience, FDA has not infrequently used repeated investigations of companies to drive their costs up and interfere with their day to day operations. It has contacted vendors and customers and, by so doing, caused them to distrust the company in question, resulting in lost contracts and sales. Those same effects can be anticipated from this bill. There is nothing in the bill to protect companies from these ! kinds of abuses.

Inadequate Safeguards Against Malicious Complaints. The bill permits public disclosure of the complaints without prior establishment by HHS that the dietary supplement was likely the cause of the adverse event. FDA presently posts on its web site every AER complaint received by the agency without proof of its validity. This system does not alter that practice but increases the likely number of reports that will be filed. The effect of publishing all complaints is to mask true instances of harm in a sea of unverified complaints. That misleads the public. It also destroys the reputations of firms through defamatory publication without affording the companies any redress. It also invites waste of tax dollars to investigate companies for bogus complaints. While the company is respo! nsible for evaluating the complaints, the bill denies the company the right to review medical information necessary to perform that evaluation. That medical information is kept from the company and, so, the company is not able to determine the cause or defend itself adequately against a false charge. Any person who wishes to impose a burden on a company can simply complain that someone, the complaining party or someone else, was seriously injured by the supplement. The company must then report the complaint to the FDA and then the FDA makes it publicly available, causing a mass defamatory impact.

Complaints Not Limited to Those Allegedly Injured. The bill is poorly drafted such that it does not limit the right to file an adverse event report to those who have suffered the alleged serious event. The definition of serious adverse event in the bill includes any event that results in "a life threatening experience" or "a persistent or significant disability or incapacity." The Reporting Requirement section of the bill makes the "responsible person" (every manufacturer, distributor, and retailer) to submit "any report received." Nowhere in this bill is there a limitation on who may submit the report. Literally anyone can. As a result, I could submit a report if I suspected that any person I saw or heard about in general had suffered what I perceived to be a life threatening experience o! r a persistent or significant disability or incapacity. There are public interest groups out there that believe virtually every dietary supplement poses a life threatening risk to users or creates a risk of persistent or significant disability or incapacity. There are others who attribute all manner of physical manifestations (whether in fact due to disease, allergy, or other ingested substances) to dietary supplements. Any of them are free to file a complaint with the manufacturer, retailer, and/or distributor. Under the bill such complaints are treated in an identical manner with those coming directly from health authorities and from consumers who take the supplements. This is a gross invitation for abuse. It will result in the maintenance of false reports along with legitimate ones and it will make it more difficult, not less, to discern the presence of actual adverse events due to the use of certain dietary ingredients in the marketplace.

Proof of Actual Injury Not Required Before Tax Dollars Spent to Investigate. The bill causes publication of the reported adverse events, invites investigation of the reporting companies, and requires response to inquiries--all without first establishing that the dietary supplement in question is in fact the cause of the harm or harms alleged. There is no requirement that the person allegedly harmed be the one to report, that he or she see a doctor and have a medical verification of suspected cause, or have the government investigate the medical background of the allegedly injured patient to determine, before posting the information publicly or investigating the company, that the harms alleged are likely caused by the dietary supplement. Moreover, the bill invites the worst kind of invalid scientific submiss! ion: self-diagnosis. The person who experiences a change in physical status is often not equipped to know with reasonable certainty whether the change is life-threatening or is a significant incapacity or disability. That calls for a medical judgment. Moreover, the person who experiences a change in physical status is not equipped to know whether a dietary supplement, as opposed to a food eaten, a chemical ingested from tainted water, exposure to chemicals, exposure to radiation, or ingestion of a drug is the likely causative factor. At best, local medical authorities are best equipped to make that determination, followed by the Centers for Disease Control and Prevention on the federal level, not FDA bureaucrats. By permitting the posting of medically unverified reports and by imposing on "responsible persons" the reporting, recordkeeping, and investigation burdens without causality, the bill adds grossly to the costs of companies in the indust! ry, wastes tax dollars, and invites confusion rather than clarity abou t the safety of dietary supplements.

Bill Denies Companies Right of Access to Medical Records Needed for Self-Defense Against False Complaints. The bill keeps confidential (except to the government) the medical records of the person allegedly harmed. That invites abuse. While the government, in its inspections of a company, may--but is not required to--have reason to believe that the dietary ingredient is the cause of a specific adverse event, the company being inspected lacks the specific information needed to determine cause. The company thus can be investigated without knowing the nature, purpose, and scope of the investigation. It can be required to produce responsive materials without knowing how those materials will be assessed. Information of this kind is time sensitive. Seeing the physical manifestations, performing t! ests to determine causality, and preserving relevant evidence all necessary to defend a company is prevented by this hiding of the pertinent information. The effect is to permit the government to mount a case against the accused without letting the accused know sufficient information to mount a defense.

Ineffectual Falsification of Reports Section. This section of the bill is totally ineffectual. A knowing falsification of a report of a serious adverse event to a responsible person is made a prohibited act under the FDCA. However, because proof of causation is not required as a condition precedent to filing a report and because medical records are withheld from the party that would be harmed by a false report, there is no basis upon which to establish the "knowing falsity" required to prove a false report to have been filed. So, the accused is left without any real remedy. Moreover, there is still no requirement that the complaining party be the one who allegedly suffered the event, there is no requirement that the report be submitted under penalty of perjury, and there is no requirement that t! he complaining party have a doctor confirm that the event is likely caused by the supplement. So, because those elements are lacking, "knowing falsity" will be all but impossible to prove. The section is wholly ineffectual and impracticable. The section, as it pertains to knowing falsification of an adverse event report, would also apply to the company submitting the report and to the complaining party. This creates a perverse disincentive for responsible persons to file reports they suspect may be false because if they have a reason to believe the report may be false, they may be making a false report themselves.

Consumers harmed by dietary supplement ingredients are best directed to physicians for treatment, for diagnosis of the real cause of harm, and for remedial measures. There is presently no proof that FDA lacks sufficient information from local responders to enforce the law against those who sell adulterated dietary supplements. In the apt phrase of others, this appears to me to be a bill in search of a problem. The framers of our Constitution warned against precisely this kind of legislating because it increases federal power at the expense of private rights.