Serrapeptase Best answer on the web
You have asked a very interesting question. The manufacturer appears to be Boie-Takeda Chemicals, Inc. located in the Philippines. I found the following document related to that:
http://www.lawphil.net/judjuris/juri1988/may1988/gr_82568_1988.html
Republic of the Philippines
SUPREME COURT
Manila
FIRST DIVISION
G.R. No. 82568 May 31, 1988
HON. ALFREDO R.A. BENGZON, in his capacity as Secretary of Health, HON. CATALINA C. SANCHEZ, in her capacity as the Director of Food and Drugs of the NATIONAL DRUG COMMITTEE of the Department of Health, petitioners, vs.
COURT OF APPEALS and BOIE-TAKEDA CHEMICALS, INC., respondents.
The Solicitor General for petitioners.
Herrera, Laurel, De los Reyes, Roxas and Teehankee Law Offices for respondents.
GRIÑO-AQUINO, J.:
The petitioner filed on April 5, 1988 a petition for review on certiorari of the writ of preliminary injunction that was issued on March 3, 1988 by the Court of Appeals (Tenth Division) in CA-G.R. No. 13859 entitled, "BOIE-TAKEDA CHEMICALS INC., Petitioner versus DEPARTMENT OF HEALTH, HON. ALFREDO R.A. BENGZON, in his capacity as Secretary of Health, et al., Respondents."
enjoining respondents and all persons acting under them from enforcing and/or giving effect to Regulation No. 1 dated 1 April 1987 (Annex "B," Petition), Regulation No. 1-A dated 10 April 1987 (Annex "C") and to the order dated 1 February 1988 (Annex "Q") and from conducting further proceedings, which shall issue upon petitioners bond for P250,000.00 executed to the respondents to the effect that petitioner will pay such damages as they may sustain and prove by reason of the writ if it should finally be decided that petitioner is not entitled thereto.
The petitioners pray that the said writ of preliminary injunction be annulled and set aside and that its enforcement be temporarily restrained during the pendency of this case.
Respondent Boie-Takeda Chemicals, Inc. (hereafter referred to as "BOIE-TAKEDA" for brevity) filed a motion to dismiss the petition, and an opposition to the application for a writ of preliminary injunction.
Treating the motion to dismiss and opposition as the respondents' comment or answer to the petition, We decided to immediately resolve the merits of the petition.
Under Republic Act No. 3720 of June 22,1963, the petitioner Secretary of Health is charged with the duty and vested with authority "to insure safe and good quality supply of drugs and to regulate the production, sale, and traffic for the same to protect the health of the people." (Sec. 2) To implement this policy, the Government shall:
(a) Establish standards and quality measures for food, drug, and cosmetic.
(b) Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country.
As amended by Executive Order No. 175 dated May 22, 1987, the statute now empowers the Department of Health to:
(a) Establish standards and quality measures for foods, drugs and devices and cosmetics.
(b) Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and devices in the country.
(c) Adopt measures to ensure the rational use of drugs and devices, such as, but not limited to, banning, recalling or withdrawing from the market drugs and devices which are not registered unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug Formulary, and the use of generic names in the labelling of drugs.
(d) Strengthen the Bureau of Food and Drugs.
Respondent Boie-Takeda is a Philippine corporation which is engaged in the manufacture, distribution, and sale of drugs, among them "Danzen" a tablet which contains serra-peptase, an OPE (oral anti-inflammatory proteolytic enzymes) which it has been licensed to manufacture and sell in the Philippines since 1970. This drug is also being sold in other countries such as Japan and in the Federal Republic of Germany. However, it is not sold in the United States.
Based on a decision dated May 30,1985 of the U.S. Food and Drug (FDA) Commissioner, and affirmed by the U.S. Court of Appeals on April 1, 1986, which determined that "oral anti-inflammatory proteolytic enzymes (OPE) which are labelled for use in controlling edema and inflammation associated with surgical, obstetrical, or dental procedures or accidental trauma to any part of the body or infections or allergic manifestations, have not been shown to be effective for such uses," the petitioner Catalina C. Sanchez, as Director of the Bureau of Food and Drugs, with the approval of petitioner Alfredo R.A. Bengzon, as Secretary of Health, "in the interest of consumer protection," issued on April 1, 1987 BFAD Regulation No. 1 s. 1987, ordering that:
l. The registration of all pharmaceutical preparations containing anti-inflammatory proteolytic enzymes, as listed in ANNEXES "A," "A-1," "A-2" and "B," "B-l" and "B-2" hereof are herby ordered recalled, which means that these drugs should no longer be marketed in the Philippines.
2. For the orderly phasing out of stocks which have been distributed to outlets prior to the issuance of this Order, all stocks should have been recalled and withdrawn by the manufacturer and distributor by October 30, 1987. (Annex "A" of Petition.)
After a week, as an addendum to BFAD Regulation No. 1, the petitioners issued BFAD Regulation No. 1-A s. 1987 dated April 10, 1987, including in the list of banned pharmaceutical preparations Boie-Takeda's Danzen tablet, 5 mg. with serratio-peptidase 10,000 U. (Annex B, Petition.)
Boie-Takeda filed with the Secretary of Health a request for reconsideration of BFAD Regulation No. 1-A on the grounds that:
l. Serrapeptase was never registered in the United States and as a consequence, data related to this enzyme was not part of the review made by the US FDA.
2. Since there has been no hearing called in connection with oral proteolytic enzymes by the Bureau of Food and Drugs, the Philippine regulatory authority, there has been no opportunity to submit data relating to serra-peptase.
3. Voluminous data on Serrapeptase has, on 20 April 1987, been submitted to the BFAD, including what might be considered carefully designed double-blind studies of serrapeptase against placebo, studies demonstrating intestinal absorption of serrapeptase by measureable quantities of the enzymia in lymph, arterial blood and venous blood, by radio-immunoassay techniques.
4. In addition, a considerable number of additional clinical studies showing clinical effectiveness of serrapeptase in various conditions, done in West Germany, France, Italy and other countries, are available and can be submitted to the BFAD.
5. Serrapeptase is registered and approved drug in some 20 countries, including the ASEAN nations, and most recently in the Federal Republic of Germany.
6. There is evidence that serrapeptase has demonstrable effectiveness not only as an anti-inflammatory drug, which was the indication for which oral proteolytic enzymes were registered in the United States, but also as a mucolytic and as an agent that enhances penetration of antibiotics and other chemotherapeutic agents into the sites of pathology. Documentation regarding these uses has been submitted to the BFAD and additional material can be supplied if necessary.
7. Additional studies are still being conducted in various parts of the world, the results of which, we anticipate, will further augment the evidence demonstrating the effectivity and uses of serrapeptase." (Annex Code. Petition.)
After a 15-minute hearing before the members of the Technical Advisory Committee on Registration of Products (TACORP), Director Sanchez of the Bureau of Food and Drugs denied Boie-Takeda's request for reconsideration (Annex E).
Boie-Takeda appealed to the Secretary of Health (Annex F) who referred the appeal to the National Drug Committee (NDC) which granted the appellant a 20-minute hearing where it submitted voluminous documentation proving the efficacy and safety of its product (Annex M), but to no avail. On February 1, 1988 Secretary Bengzon informed Boie-Takeda that the National Drug Committee confirmed the recall and cancellation of registration of "Danzen" tablets and directed the company "to discontinue marketing the said product effective as of receipt of this notice." (Annex N).
Alleging that the cancellation of the registration of its product was done without due process of law, Boie-Takeda filed in the Court of Appeals a petition for certiorari and prohibition with preliminary injunction (CA-G.R. SP No. 13859 entitled, "Boie-Takeda Chemicals Inc. versus Department of Health, Hon. Alfredo R.A. Bengzon, et al.") praying, among other reliefs, that a writ of preliminary injunction be issued to restrain the Secretary of Health from enforcing BFAD Regulation No. 1-A pending the determination of the case.
Upon receipt of the petition, the Court of Appeals issued a temporary restraining order and set the hearing of the application for preliminary injunction on February 22, 1988. After oral arguments at the hearing, the parties submitted their respective memoranda.
On March 3, 1988, the Court of Appeals granted the writ prayed for (Annex A, p. 98, Rollo).
This resolution of the Court of Appeals was elevated to Us by the Secretary of Health on a petition for certiorari and prohibition with preliminary injunction alleging grave abuse of discretion in issuing the same.
As the issuance of a writ of preliminary injunction is an exercise of the Court's sound discretion, the only point of inquiry in the petition before Us is whether the Court of Appeals committed a grave abuse of discretion in issuing the writ. The matter of whether the respondent herein, Boie-Takeda (petitioner in the Appellate Court) was denied due process of law in the proceedings before the administrative bodies, namely, the Secretary of Health, the Bureau of Food and Drugs (BFAD), the National Drug Committee (NDC), and the Technical Advisory Committee on Registration of Products (TACORP), is not for Us to determine as it is still pending adjudication in CA-G.R. SP No. 13859.
A writ of preliminary injunction, as an ancillary or preventive remedy may only be resorted to by a litigant for the preservation or protection of his rights or interests, and for no other purpose, during the pendency of the principal action (Calo vs. Roldan, 76 Phil. 425).
Here, the writ was issued to protect and preserve the right or license of the private respondent Boie-Takeda to market its product "Danzen" in the Philippines, which it has been doing since 1970 or for the past 17 years. Hence the object of the writ is to preserve the status quo, or the last actual peaceable uncontested status which preceded the pending controversy (Rodulfa vs. Alfonso, 76 Phil. 225) which, as correctly noted by the Court of Appeals, "is the status before the withdrawal order" was issued. The status quo before the ban or withdrawal order was issued, was that Boie-Takeda's product, "Danzen" tablets, was registered and being sold in the Philippines under proper license from the Bureau of Food and Drugs. That status quo is what the writ of preliminary injunction seeks to preserve pending a final determination of the merits of Boie-Takeda's petition in CA-G.R. SP No. 13859.
Significantly, the writ was granted after a hearing where both parties were given an opportunity to present their arguments which they amplified with memoranda. (Said hearing SCRA 796). As a general rule, this Court should refrain, in certiorari proceedings, from interfering with the lower court's exercise of its discretion in issuing a writ of preliminary injunction except in cases of manifest abuse (Rodulfa vs. Alfonso, 76 Phil. 225; Agno River Gold Dredging Co. vs. De Leon, 61 Phil. 190; Detective & Protective Bureau, Inc. vs. Cloribel, 26 SCRA 255).
We rule, therefore, that respondent Court of Appeals did not commit a grave abuse of discretion in issuing a writ of preliminary injunction ordering the petitioners to desist from enforcing and implementing the withdrawal order (BFAD Regulation No. 1-A dated April 10, 1988) at least while the aggrieved party's petition for judicial review of the administrative proceedings is still pending determination by that Court.
WHEREFORE, the petition for certiorari and prohibition is denied.
SO ORDERED.
Narvasa, Cruz, Gancayco and Medialdea, JJ., concur.
The Lawphil Project - Arellano Law Foundation
I also found a very nice biography of the late Dr. Nieper:
http://www.findlongevitynow.com/aboutnieper_bio.html
Dr. Hans A. Nieper was born on May 23, 1928, in Hannover, Germany. Both parents were physicians. His great-grandfather was the founder of the mental hospitals in Ilten, near Hannover. His grandfather was a well-known surgeon in Goslar. Dr. Nieper is active in Hannover as an Internist and the Director of Medicine at the highly acclaimed Paracelsus Silbersee Hospital. Patients seeking his assistance come from all continents, predominantly North America, Europe, South Africa and Australia. Internationally, he has become one of the best-known physicians in the fields of cancerous diseases, multiple sclerosis, mineral and electrolyte metabolism, aging, and the prevention of cardiac disease.
Dr. Nieper studied in Mainz, Freiburg and Neuchâtel between 1946 and 1952. He completed his doctoral examinations "Summa Cum Laude," in Hamburg, with the explanation of the so-called Boeck's sarcoid as an autoimmune disease. At the time, such a disease principle was still considered a utopian fabrication-today it is a recognised reality.
In the following decades, Dr. Nieper worked in various German medical institutes and cancer research laboratories, instilling in him the certainty that the cancer therapy practised then, and now (cancer treatment with poisonous cytostatic substances) was predominantly on the wrong track. As an internist, he engaged in scientific investigation of important questions in the field of immunology, and together with a very well-known German chemist, he discovered and developed various new health curatives, which laid the foundation for his later world-wide fame. These developments include the 'mineral carriers' Aspartates and Orotates, as well as the salts of the cell membrane component AEP, which can screen cell membranes from attack by immune bodies. Dr. Nieper thus became the discoverer of the only product officially declared, world-wide, as medication against multiple sclerosis.
Towards the end of 1960, Dr. Nieper went to Aschaffenburg, to the laboratory of the renowned cardiologist, Professor Kj. Blumberger, where he began introducing potassium and magnesium aspartates into heart therapy.
Because of his extensive study of non-poisonous methods for the long-term treatment of cancer, he became a star witness for powerful American civil rights organizations opposing toxic "orthodox" medicine and government therapy regulation. For this reason, Dr. Nieper's following in the English-speaking countries is counted in the millions, and his influence in all fields is quite pronounced. He has a close friendship with a large number of renowned scientists and artists, including the American cancer researcher Dr. Dean Burk, the best-known disciple of Berlin's double Novel-laureate Otto Warburg.
The routine introduction of selenium therapy for heart protection, the introduction of the so-called deshielding or deblocking therapy of cancer with pineapple enzymes and beta-carotene, and the modern "de-sodification" of cancerous tumours represent only one phase of his new clinical practical activities. Also the enzyme-based cleaning of coronary and leg arteries is quite remarkable. In the year 1971, Dr. Nieper, as a result of his own investigations, introduced beta-carotene routinely into the protective cancer therapy. At the time frequently ridiculed, this method is today fully accepted in the scientific world literature as one of the most effective methods available.
Around 1980, Dr. Nieper came to the scientific conclusion that the potentially very effective defense against cancer by the body itself has to be explained in terms of "gene repair," and not as an immune defense alone. Soon after, anticancer gene repair substances were found in man as well as in other species, such as in plants and insects. This has proven to be a decisive turn in the fight against cancer.
As early as 1946, Dr. Nieper became critical of certain aspects of the predominant theories in physics. In 1953 he developed a so-called shielding theory of gravitational effects, and reintroduced the ether "abolished" by Einstein. In 1970, with the aid of American friends such as the McNaughton Foundation of San Francisco, the founder of AMPEX, A.M. Pontiatoff, and the Telluron Brain Center in Santa Monica, he further developed his ideas on gravity. Because of his results, in 1973, he was presented to the U.S. Senate. There was further progress in 1977, following a session at NASA-AMES at Moffett Field in California, among well-known scientists, including Dr. Arthur D. Alexander. There Dr. Nieper conceived of the so-called perisolar cushion theory of the Tachyon-Field. (Complete explanation in Dr. Nieper's Revolution in Technology Medicine and Society, the 384-page book available in English, German and French advances today's knowledge in several fields such as the conversion of Gravity Field Energy and explains the inextricable relationship between the body's cellular energy and our own personal health.)
Overall, Dr. Nieper has published approximately 360 articles and essays and holds 131 International Patents.
Dr. Nieper is now the Honorary President of the German Association of Vacuum Field Energy and Physics, after founding and presiding the Association for 17 years. He also later co-founded the American Association of Gravity Field Energy. These are the first associations in the World dedicated to space energy technology.
In Germany, he is the founder and was the first 5-year President of the German Society of Oncology. This biologically oriented cancer society grows tremendously and is now the biggest cancer society in all of Europe. He is also a life member of the German Society of Natural Scientists and Physicians.
In the USA, Dr. Nieper is an active member of the New York Academy of Sciences, the American Association for the Advancement of Sciences, the American College of Nutrition and other societies. He was Honorary President of the International Academy of Preventive Medicine for two years and is also Honorary Director of this academy, along with double Nobel-laureate Linus Pauling and vitamin chemist Roger Williams. He is furthermore, an honorary member of the Center of Frontier Sciences, Temple University, Philadelphia.
In Canada, he is a member of the Planetary Association for Clean Energy.
In France, he is a member of the Société Agressologie, directed by his friend, Henri Laborit.
Dr. Nieper died in his sleep on 21 October 1998. Although this is a great loss to the global health community, he left behind a wealth of information that will be beneficial for generations to come.
Here is a very interesting article about Serrapeptase:
http://www.clubnatural.com/serpowsilanc.html
The silkworm holds a treasure beyond the luxury of exquisite textiles. It’s called serrapeptase (AKA Serratio Peptidase or SP, DanzenTM, AniflazymTM SerraZymeTM), a powerful protolytic enzyme that dissolves all nonliving tissue, including blood clots, cysts, arterial plaque and inflammation in all forms.
The mighty enzyme offers a viable alternative to salicylates (such as aspirin), ibuprofen, and NSAIDS as well as steroids—a boon for those suffering with rheumatoid arthritis and a wide array of other autoimmune diseases that affect the inflammatory response, including ulcerative colitis, psoriasis, uveitis, allergies, and some forms of cancer.
While steroidal and nonsteroidal antiinflammatory drugs may offer temporary, symptomatic relief from pain, swelling and inflammation, they may also be immunosuppressive and known to hold dangerous side effects. Serrapeptase, on the other hand, eases pain and swelling with no inhibitory effects on prostaglandins and no gastrointestinal side effects. The immunologically active enzyme is completely bound to the alpha 2 macroglobulin in biological fluids.
The physiologic agent is isolated from the microorganism Serratia E15, an enzyme naturally present in the silkworm intestine which allows the emerging moth to dissolve its cocoon. Clinical use of serrazyme as an antiinflammatory in Europe and Asia spans over twenty five years. Treatment includes chronic sinusitis, elimination of bronchopulmonary secretions (the enzyme breaks down protein fibers, allowing mucous to thin), sprains and torn ligaments, and other traumatic injuries, idiopathic edema, as well as postoperative inflammation.
Studying postoperative swelling and pain reduction of the upper ankle joint, a test was carried out in 3 randomized groups of 66 patients, each with fresh rupture of the lateral ligament treated surgically between December 1986 and April 1987. The group receiving SP saw a 50% decrease in swelling on the third postoperative day. Decreased pain, for the most part, correlated with reduction in swelling. The SP group became rapidly pain-free. The two control groups, using traditional elevation of the leg, bed rest, with and without applications of ice, had no reduction in swelling at that time. (Esch PM, Gerngross H, Fabian A, Fortachr Med,107(4):67.8, 71-2 1989 Feb 10)
Another multi-centre, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of SP in 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg SP 3 times the day before surgery, once the night of the operation and 3 times daily for 5 days after surgery; the other 86 received a placebo. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after surgery up to the 5th day. Maximal buccal swelling throughout all the postoperative points of observation was also significantly smaller in size in the SP group. No side effects were reported. (Tachibana M, Mizukosi 0, Harada Y, Kawamoto K, Nakai Y. Source: Pharmathera-peutica, 3(8):526-30 1984).
Additionally, SP in a 70 patient, double-blind controlled trial treating breast engorgement saw SP improve breast pain and swelling in significant numbers of the treatment group with no adverse reactions. (Kee WH, Tan SL; Lee V, Salmon YM .Singapore Med J, 30(I) :48-54 1989 Feb)
Researchers in Germany have used SP to treat atherosclerosis since serrapeptase helps to digest atherosclerotic plaque without harming healthy cells lining the arterial wall. The hardened, narrow arterial wall is considered the cumulative result of microscopic trauma with inflammation occurring in the presence of oxidized lipids—serrapeptase works on both inflammation as well as dissolving the avital plaque. Unlike cholesterol-blocking drugs, serapeptase clears the avital tissue from the arterial wall without interfering with cholesterol synthesis. In fact, when taking serrapeptase, cholesterol levels may rise as it is dissolved from the arteries to be eliminated from the body (cholesterol in its pure state is an antioxidant and a necessary component of steroidal hormones and the major organ systems in the body).
Medications blocking cholesterol biosynthesis hold the threat of liver, eye, lung and other soft tissue damage. While studies with SP in the treatment of coronary artery disease are relatively new; some literature reports SP as being superior to, and faster than, chelation.
The late German physician Dr. Hans Nieper used serrapeptase to treat arterial blockage in his coronary patients, reporting that serrapeptase also dissolves blood clots, and causes varicose veins to shrink or diminish. Dr. Nieper told of a woman scheduled for hand amputation and a man scheduled for bypass surgery; both recovered quickly without surgery after treatment with serrapeptase.
In addition, widespread use has included fibrocystic breast disease and carpal tunnel syndrome.
The enzyme is also used to facilitate the therapeutic effect of antibiotics in the treatment of infection. In urology serrapeptase has been successfully employed to treat cystitis and epididymitis.
Serrapeptase is available as SerraZyme in 10 mg enterically coated tablets that are equivalent to 20,000 IU activity.
Recommended Usage: For inflammation is 1 tablets three times daily on an empty stomach. For arterial blockage 1 tablets twice daily or as directed by your health professional. (In acute conditions, your health care professional may recommend that you take 2 tablets on an empty stomach 6 times per day). , Julia Busch 2000
Reprinted from the "So Young" holistic health, antiaging newsletter.
SerraZyme is available from the "So Young" catalog. To order (or for a free antiaging catalog) call 800 SO YOUNG (800-769-6864) or email julia2@gate.net
Obviously there are differing opinions concerning Serrapeptase. I never listen to what others say and rely upon my own judgement.
Good luck, Redhoss
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