Tradition I - In concert with Big Pharma, total commitment to a healthcare system based on the treatment of disease with drugs, almost all of which address only symptoms, many of which are dangerous, some of which are deadly. The suppression of internal critical dissent
Tradition II - In concert with Big Pharma, hostility to, and actions
designed to suppress, healthcare based on the prevention of disease through nutrition
Tradition III - Retirement of FDA officials to executive positions with Big Pharma
Inception of a Fourth FDA Tradition – The FDAAA
=======================================================
Tradition I - In concert with Big Pharma, total commitment to a healthcare system based on the treatment of disease with drugs, almost all of which address only symptoms, many of which are dangerous, some of which can be deadly. The suppression of internal critical dissent
To describe this tradition would require a virtual library of references documenting a minimum 100,000 deaths per year and a much greater number of cases with serious side effects, all from the proper, physician-prescribed use of FDA-approved drugs, the collusion of top FDA officials with Big Pharma, and their suppression of, and threats of legal action against, dissenting scientists within their own ranks.
A few references and facts from a voluminous library of documentation:
1975
"A General Accounting Office (GAO) study of FDA in 1975 revealed that 150 FDA officials owned stock in the companies they were supposed to regulate." -Barry Lynes, _The Healing of Cancer_, Marcus Books, Box 327, Queensville, Ontario, L0G 1R0, Canada, 1989, pg. 22
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1985
"GAO (General Accounting Office) found that of the 198 drugs approved by FDA between 1976 and 1985...102 (or 51.5%) had serious postapproval risks...the serious postapproval risks...(included) heart failure, myocardial infarction, anaphylaxis, respiratory depression and arrest, seizures, kidney and liver failure, severe blood disorders, birth defects and fetal toxicity and blindness."
-FDA Drug Review: Postapproval Risks 1976-1985, GAO/PEMD 90-15, pg. 3
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1989
The Legacy of Tambocor
http://www.ralphmoss.com/cach381.html
“The death toll from these class I anti-arrhythmics will never be known for certain. But Moore presents compelling evidence that between the years 1989 and 1990, between 40,000 and 70,000 lives per year were lost from the six largest-selling class I drugs. And that was only two years' toll.
"Throughout the decades," says Moore, "it is clear that hundreds of thousands died prematurely... Everyone involved--drug companies, marquee professors, FDA officials, outside cardiologists--all united on this one point, that above all other things, the public must not know the numerical dimensions of the tragedy. …And, predictably, after the Congressional hearings, there was not a single television story, no wire service story, in fact practically no news coverage at all. When the hearing ended, Temple knew he had won. He walked over to Mitch Zeller in the nearly empty chamber. "You still don't get it," he said. Then he smiled and left the room.”
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1998
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA . 1998 Apr 15;279(15):1200-5.
OBJECTIVE: To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. DATA SOURCES: Four electronic databases were searched from 1966 to 1996. STUDY SELECTION: Of 153, we selected 39 prospective studies from US hospitals. DATA EXTRACTION: Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. DATA SYNTHESIS: The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2,216,000 (1,721,000-2,711,000) hospitalized patients had serious ADRs and 106,000 (76,000-137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. CONCLUSIONS: The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.
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1997-2001
Sample Four-Year Track Record of FDA-Approved Drugs, 1997-2001
Pondimin/fenfluramine (Wyeth-Ayerst) approved:1973 for weight loss, obesity; adverse effects:pulmonary hypertension, heart valve disease; withdrawn:sep.97
Redux/dexfenfluramine (Wyeth-Ayerst) approved:apr.96 for weight loss, obesity; adverse effects:pulmonary hypertension, heart valve disease; withdrawn: sep.97
Seldane/terfenadine (Hoescht Marion Roussel) approved:1985 for seasonal allergies; adverse effects:heart problems when taken with other drugs; withdrawn:dec.97
Posicor/mibefradil (Roche Laboratories) approved:june 97 for hypertension and angina; adverse effects:reduced activity of liver enzymes lead to harmful drug build-up, interactions too numerous for risk management; withdrawn:june 98
Duract/bromfenac (Wyeth-Ayerst) approved july 97 for pain relief; adverse effects: hepatitis, liver failure after treatment exceeded 10 days; withdrawn june 98
Hismanal/astemizole (Janssen Pharmaceutica) approved 1988 for seasonal allergies; adverse effects:heart arrhythmia caused by interaction with other drugs; withdrawn:june 99
Raxar/grepafloxacin (Glaxo Wellcome) approved:nov.97 as antibiotic to treat pneumonia, bronchitis, some STDs; adverse effects:severe cardovascular problems (torsade de pointes, a ventricular arrhythmia); withdrawn: oct.99
Rezulin/troglitazone (Parke-Davis/Warner-Lambert) approved:jan.97 for Type 2 diabetes mellitus; adverse effects:liver toxicity; withdrawn:march 00
Propulsid/cisapride (Janssen Pharmaceutica) approved:july 93 for night time heartburn; adverse effects:cardiac arrhrythmia; withdrawn: july 00
Lotronex/alosetron (Glaxo Wellcome) approved: feb.00 for irritable bowel syndrome; adverse effects: ischemic colitis; withdrawn: nov.00
Raplon/rapacuronium bromide (Organon Inc) approved:aug.99 for airway muscle relaxment during surgery; adverse effects:bronchospasm; withdrawn:march 01
Baycol/cerivastatin (Bayer) approved:sep.97 for high cholesterol; adverse effects: rhabdomyolysis (muscle deterioration), possible renal and other organ failure; withdrawn:aug.01
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2000
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
http://www.handpen.com/Cancell/FDA_conflect.html
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FDA keeps adverse reports of gene therapy from patients, volunteers and the public to protect trade secrets
“The researchers told the (Washington) Post they reported the deaths to the Food and Drug Administration, which keeps such information secret.”
http://dailynews.yahoo.com/h/nm/20000202/ts/health_genetherapy_1.html
(inactivated link)
http://www.newsweekly.com.au/articles/2000aug12_bio.html
“Paul Gelsinger said he did not learn about any of the serious dangers his son was facing until it was too late. He didn’t know that two Rhesus monkeys had died in tests involving a gene delivery system similar to the one used with Jesse; he didn’t know that four other human patients had suffered toxicity to their livers earlier in the study….[He] blamed the FDA for withholding vital information about this experiment from public scrutiny, information that would have made the researchers cautious about conducting the fatal experiment on his son.”
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2001
Lotronex and the FDA: “A fatal erosion of integrity”
Richard Horton, Editor, Lancet
The Lancet 2001; 357:1544-1545
http://www.thelancet.com/journals/lancet/article/PIIS0140673600047760/fulltext
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2003
Iatrogenic Death by FDA-Approved Drugs
http://www.garynull.com/events/newsletter/index.aspx
November - December 2003
DEATH BY MEDICINE
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2004
FDA Officials First Suppress Antidepressant-Child-Suicide Report,
Then Launch a Criminal Investigation Into Its Leak
http://www.bmj.com/cgi/content/full/329/7461/307
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Vioxx Deaths and GAO Investigation of FDA
http://www.bmj.com/cgi/content/full/329/7472/935
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2005
Some typical side effects of FDA-approved drugs from a randomly-chosen single sample month (May 2005):
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2005
http://www.fda.gov/medwatch/SAFETY/2005/may05.htm
Coronary Heart Disease and Stroke
Ovarian Cancer
Liver Dysfunction
Impaired Renal Function
Heart Failure
Carcinogenesis, Mutagenesis, Impairment of Fertility
Risk of GI Ulceration, Bleeding, and Perforation
Advanced Renal Disease
Chronic Hepatitis B
Hallucinations
Hepatic Failure
Teratogenic Effects
Peripheral and Optic Neuropathy
Anaphylactic reactions (including life-threatening anaphylactic shock)
“…(sometimes) death”
As far as the FDA is concerned, including this information in a warning box allows these and other drugs with similar side effects to continue to be prescribed and dispensed as “FDA approved”.
--------------------------------------------
2006
Unabated Tradition - Conflict-of-Interest Ties of FDA Drug Advisors
FDA Puts Five Scientists with Conflicts of Interest On Committee Evaluating Controversial MS Drug
http://www.gooznews.com/archives/000288.html
http://www.ahrp.org/cms/content/view/92/28/
FDA Stent Experts - Conflict of Interest Ties
http://www.bloomberg.com/apps/news?pid=20601103&sid=aC0N5sNeh6G4&refer=us
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FDA Staff Travels on Drug Industry Dollars
Groups tied to FDA-regulated industry paying for agency officials' trips
http://www.publicintegrity.org/rx/report.aspx?aid=792
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Gottlieb, FDA Deputy Commissioner With BigPharma Ties, Contrived to Protect Big Pharma With “Federal Preemption” Ploy
http://www.boston.com/business/healthcare/articles/2005/11/12/fda_official_recused_in_flu_fight/
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/18/AR2006011802320.html
Paxil, Birth Defects, and the FDA Preemption Ploy
http://www.sierratimes.com/06/12/28/75_7_240_61_62632.htm
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Gottlieb-Woodcock Policy of Fast-Track Drug Approval
http://www.nytimes.com/2005/12/21/politics/21cancer.html?ex=1167973200&en=181c66263d900259&ei=5070
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SJS From FDA-Approved Drugs
SJS - Called A Fate Worse Than Death
http://www.opednews.com/articles/genera_evelyn_p_060222_sjs___called_a_fate_.htm
---------------------------------------------
Links to 64 Drugs With Serious Side Effects (heart attacks, cancer, kidney damage…)
http://www.adrugrecall.com/
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Investing Drugs With the Appearance of Efficacy Through the Ploy of “Surrogate Endpoints” – an Ongoing, Inviolate FDA Tradition:
The only therapeutic modality the top FDA officials are committed to
for the treatment of health problems and disease is drugs, which, in fact, almost always simply address symptoms and often carry serious side-effect risks. This position is also, of course, most profitable for Big Pharma, assuring them of indefinite years of treatment with their drugs for patients with “chronic” health problems which are guaranteed to remain chronic. To confer the appearance of therapeutic efficacy on such drugs, the FDA has devised impressive-sounding synonyms for their effect on symptoms, viz., “biomarkers” and “surrogate endpoints”. It has dubbed these endpoints legitimate drug standards, and works intimately with the drug industry on how to use these endpoints, rather than the most, if not only, legitimate endpoints of cure or reduced mortality, as a measure, and as a demonstration of the purported efficacy, of these drugs.
http://www.healthyskepticism.org/promotion/textbook/mislead/surrogat.htm
http://www.ralphmoss.com/cach381.html
PULLOUT BOX: SURROGATE ENDPOINTS
2006 CV BioMarkers and Surrogate Endpoints Symposium
http://www.cfsan.fda.gov/~acrobat/registe4.pdf
Biomarker Development Strategies Conference , Jan. 29, 2007
http://www.exlpharma.com/events/ev_descrip.php?ev_id=49&gclid=CKCa_NqKvokCFRMWFQodtVIxWA
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Which Is More Dangerous -The Flu or the FDA?
http://www.rutherford.org/articles_db/commentary.asp?record_id=449
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Senator Grassley On FDA-Merck Collaboration Against Dr. Graham
http://www.ncac.org/science/20060719~USA~FDA_Collaboration_in_Vioxx_Smear_Campaign_Investigated.cfm
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TraditionOfSuppression:
FDAElashoffGalsonLutwakSeligman
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/lutwak.html
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Ketek:
VonEschenbachOrdersDataOnKetekSuppressed,ThreatensStaff
http://www.cbsnews.com/stories/2006/12/13/cbsnews_investigates/main2259865.shtml
http://www.cbsnews.com/htdocs/pdf/Letter_Eschenbach_Ketek.pdf
http://ketek.martinandjones.com/
==========================================================
Tradition II - In concert with Big Pharma, hostility to, and actions designed to suppress, healthcare based on prevention of disease through nutrition
A few references from a voluminous library of documentation:
1949
"The activities of...so-called health food lecturers have increasingly engaged our attention...(we are fighting) the good fight against dried vegetables, mineral mixtures, vitamins and similar products."
Dr. George Larrick, FDA Commissioner, Minutes of the Proprietary Association Convention, 1949, White Sulphur Springs, Virginia (as reported by Omar V. Garrison in _The Dictocrats_, ARC Books, New York, 1970, pg. 30)
---------------------------------
1970
"(It is) not our (FDA) policy to jeopardize the financial interests of the pharmaceutical companies."
-FDA Commissioner Charles C. Edwards in testimony before the House Subcommittee on Intergovernmental Relations, 1970, as reported in "Who Blocks Testing of Anti-Cancer Agent," _Alameda (California) Times Star_, August 3, 1970
--------------------------------
1984
"The Pharmaceutical Advertising Council (PAC) and the United States Food and Drug Administration have just announced a unique program...to warn the public about the dangers of quack medical products..."
-From an October 22, 1984 letter signed jointly by Frank Young, FDA Commissioner and Roger O'Neill, president of PAC, on PAC/FDA letterhead
--------------------------------
1985
"...attached is a list of companies...who have donated money to the PAC/FDA anti-quackery program..."
Beecham Laboratories Merck Sharpe and Dohme
Bristol Meyers Company Organon, Inc.
Burroughs Wellcome Co. Pennwalt Co.
Carter Wallace Inc. The Proprietary Association A.H. Robbins Hoechst-Roussel Pharmaceuticals Hoffman-LaRoche Inc.
Rover Group Janssen Pharmaceutical
Sandoz Jeffrey Martin Inc.
Schering Corp. Johnson & Johnson
Squibb Knoll Pharmaceutical
Sterling Drug, Inc. Lederle Laboratories
Stuart Pharmaceuticals McNeil Company
Syntex Corporation Warner Lambert Company
From a November 15, 1985 letter on PAC/FDA letterhead signed by John Chusid, coordinators, PAC/FDA anti-quackery program
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1992
FDA Task Force considered “…what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.”
Food and Drug Administration. Dietary supplements task force. Final report, Dept Health and Human Services, May 1992.
FDA Police Raid
http://www.ralphmoss.com/wright.html
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1993
"...pay careful attention to what is happening (with dietary supplements) in the legislative arena...if these efforts are successful, there could be created a class of products to compete with approved drugs that are subject to less regulation than approved drugs...the establishment of a separate regulatory category for supplements could undercut exclusively rights enjoyed by holders of approved drug applications."
-David Adams, FDA Deputy commissioner for Policy before the Drug Information Association Annual Meeting, July 12, 1993, _D-C-A Tan Sheet 11_, July 19, 1993
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FDA - Nutrition as Unapproved, Possibly Dangerous Drugs
http://www.cfsan.fda.gov/~dms/fdsupp.html
An FDA Guide to Dietary Supplements
“A drug, which sometimes can be derived from plants used as traditional medicines, is an article that, among other things, is intended to diagnose, cure, mitigate, treat, or prevent diseases.”
This seemingly innocuous statement is taken by the FDA brains to run logically in two directions - not only is a drug a substance which has a beneficial effect on disease, but - run in reverse - anything which has a beneficial effect on disease is, ipso facto, a drug. This brilliant conclusion follows ineluctably from the axioms of FDA-managers’ Logic. What then follows from this, according to FDA regulatory policy and police action,
for, say, a nutrient such as Vitamin C?
It’s a bird, it’s a plane…
If recommended “for the prevention and treatment of scurvy”, it’s adjudged a legal (and therefore safe) FDA-approved drug.
If recommended “for some possible health benefit in cancer”,
it’s adjudged an unapproved, illegal, and possibly hazardous drug.
As a supplement distributor, you would be threatened with closure
of your business or would be raided.
If not recommended for anything, it’s adjudged a legal dietary supplement.
"It apparently is FDA's view that if a company makes a claim that milk helps prevent rickets, milk suddenly becomes a drug."
-Federal Judge Lowell Jensen, District Court, San Francisco,
in the _Nutricology_ case, September 23, 1993
The Hazardous-Nutritional-Supplements-Target of FDA Police Raids:
Annual Deaths From:
FDA-Approved Drugs (1).......60,000 - 140,000
Food Contamination (2)...........................9,100
Aspirin (3)......................................................90
All vitamins (4). ............................................ 0
Uncontaminated amino acids (4)..................0
Commercial herbs (4).................................... 0
1. Classen, et al., "Surveillance of Adverse Drug Events," JAMA, 1991
2. Centers for Disease Control
3. FDA Fact Sheet, July 1971
4. American Association of Poison Control Centers (data for years 1983-1990 as published in _American Journal of Emergency Medicine_)
FDA Police Raid
http://www.realgh3.com/victory.html
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"The Food and Drug Administration report, _Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace_, released July 29, 1993 at a House Subcommittee hearing on dietary supplements, should be immediately withdrawn and FDA should apologize to the Congress and the public for its release. This false and misleading document is so riddled with inaccuracies that it lacks any evidentiary value and raises serious questions about the motives of those who are responsible for its preparation… FDA has knowingly submitted false information to Congress...it has willfully violated the presumption of accuracy and impartiality traditionally granted the agency. The report conclusively proves FDA's animosity to dietary supplements." "The Clinton Administration must take immediate steps to discipline those who have participated in the preparation and submission of this misleading document..." -_
False and Misleading: Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace_, A Staff Report to Senator Orin G. Hatch, October 21, 1993, pg. 1
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1976-1996
Folic Acid, Neural-Tube Defects and the Unborn Children Permanently Maimed by FDA Medical Neanderthals (“nutritional policy from prehistoric times”)
A Medline search of the words: [folic neural tube defects] yields
1464 citations.
The first Medline citation on the association of neural tube defects and folic acid deficiency dates from 1976:
Vitamin deficiencies and neural tube defects.
Smithells RW, Sheppard S, Schorah CJ.
Arch Dis Child. 1976 Dec;51(12):944-50.
Abstract:
"Serum folate, red cell folate, white blood cell vitamin C, riboflavin saturation index, and serum vitamin A were determined during the first trimester of pregnancy in over 900 cases. For each of these there was a (sic) social classes I + II showed the highest levels which differed significantly from other classes, except for serum folate. In 6 mothers who gave birth to infants with neural tube defects, first trimester serum folate, red cell folate, white blood cell vitamin C, and riboflavin values were lower than in controls. In spite of small numbers the differences were significant for red cell folate (P less than 0-001) and white blood cell vitamin C (P less than 0-05). These findings are compatible with the hypothesis that nutritional deficiencies are significant in the causation of congenital defects of the neural tube in man."
In 1980:
Possible prevention of neural-tube defects by periconceptional vitamin supplementation.
Smithells RW, Sheppard S, Schorah CJ, Seller MJ, Nevin NC, Harris R, Read AP, Fielding DW.
Lancet. 1980 Feb 16;1(8164):339-40.
“Women who had previously given birth to one or more infants with a neural-tube defect (NTD) were recruited into a trial of periconceptional multivitamin supplementation. 1 of 178 infants/fetuses of fully supplemented mothers (0.6%) had an NTD, compared with 13 of 260 infants/fetuses of unsupplemented mothers (5.0%).” [8-fold increase]
In the years following the Smithells 1980 Lancet paper, despite additional, corroborating evidence of a folate-neural-tube-defect link and appeals to the FDA by numerous health practitioners and organizations, the FDA remained adamant - it would allow the striping of folic acid from grains through food processing, but would forbid its reintroduction in grain products at a level needed to prevent spina bifida in unborn children.
It also forbid folic acid in vitamin supplements at such preventive levels.
Over a span of the next 16 years, FDA officials first used one spurious argument, and when that collapsed succeeded it by a different spurious one, to rationalize their refusal to allow the fortification of grains or supplements with folic acid. Their first stance was simply to deny any link between folic acid deficiency and neural tube defects.
www.whsc.emory.edu/_pubs/ph/spring01/epi.html
Emory University 2001
Fall 1991: The FDA declares that folic acid does not prevent birth defects among high-risk women… November 1991: The FDA asks CDC officials
to sign off on a statement in the Federal Register to read "Folic acid
does not prevent spina bifida. The CDC declines.
When this stance eventually proved hopelessly untenable for them, they retreated to a different argument - the hypothetical masking of undiagnosed pernicious anemia in the elderly by folic acid. These officials could have guided their actions by the Precautionary Principle, calling for the fortification of grains with both B-12 and folic acid. This would have addressed the need to treat both undiagnosed pernicious anemia in the elderly and the neural-tube-risk of pregnant women. Instead they took a surreal tack - the concomitant disallowance of fortification of grains with
B-12. Then - Alice in Wonderland – they used their own tack on B-12 as
a vital ingredient of their second argument for not fortifying grains with folic acid, viz., the specter of masking pernicious anemia with folic acid alone, in the absence of B-12! Obsessively adhering to their anti-nutrition mindset, these top FDA officials, employing this Catch-22 ploy of obstruction, continued to disregard the plight of at-risk unborn children and ended up crippling thousands of them.
To this day, FDA officials have continued to play their anti-nutrition cards on this subject. When, after years of denial, they were finally forced
to admit both a neural-tube-defect-folate link and the need for folate fortification, they now acted as Oracular authorities on the suddenly obvious benefits of folate, issuing a proclamation of omniscience that
an intake of 0.4mg folate was sufficient for preventing neural tube defects
and that supplementation with more than 0.4mg folate was both of
no benefit and not allowed.
Godfrey Oakley:
http://www.whsc.emory.edu/_releases/2003october/oakley.html
Godfrey Oakley: A FLAMING FAILURE
http://www.findarticles.com/m1189/5_27/55481487/p1/article.jhtml
“…when the fortification decision was made, it wasn't made to give women of reproductive age enough folic acid, so the fortification gives the average woman only one fourth of what is recommended by the Public Health Service and by the Institute of Medicine…To me, the guilt belongs at the doorstep of the commissioner of the Food and Drug Administration. Whoever is sitting in that job can this minute solve the problem for the whole country by changing one thing: The concentration of folic acid required in enriched cereal grains should be about 700 mcg, or five times what it currently is… due to human stupidity, roadblocks are set up…It is nutritional policy from prehistoric times that is keeping this important fortification from taking place… the policy on folic acid is a flaming failure leading to an epidemic of birth defects we don't need to have... the Institute [of Medicine] provided cover for the FDA to add B12 to bread which people over 50 need, and the FDA hasn't moved on that, either.”
The victims of the FDA folic-acid ban?
The children with preventable spina bifida born over the period 1980-1996.
“According to David Satcher, M.D., Ph.D, Director, Centers for Disease Control and Prevention [1990-93], CDC estimates that there are approximately 4,000 pregnancies each year, including 2,500 live births, that are affected by spina bifida and other neural tube birth defects.”
http://www.kidsource.com/kidsource/content/news/folic_acid.html