In other arthritis related research, preliminary results from a 24-week clinical trial in Europe "Glucosamine Unum in Die Efficacy (GUIDE) Trial" found that glucosamine sulfate was more effective in relieving osteoarthritis pain than the pain medicine acetaminophen. Again, this is very good news for people taking this prescription drug since they now have an alternative, with proves effectiveness, without the unwanted side-effects and dangerous adverse responses.
Results of both the GAIT and GUIDE studies are being presented this week at the annual scientific meeting of the American College of Rheumatology (ACR) in San Diego and abstracts are posted on ACR’s website: http://www.rheumatology.org/annual/index.asp.
It is good to see that the GUIDE study used glucosamine sulfate. The GAIT study used glucosamine hydrochloride. Most studies have used the sulfate version and it is the one used most commonly in widely available supplements.
Commenting from the ACR meeting, Dr. Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, said research also suggests that glucosamine and chondroitin may similarly help others at risk for osteoarthritis or those who are experiencing joint discomfort, including athletes involved in high-impact sports such as basketball or running.
Referring to the GAIT study he said "We believe that the results from this well-executed NIH-sponsored study not only indicate that more research is needed to determine the full potential of glucosamine and chondroitin, but also reconfirm that these supplements can help the growing number of Americans with joint problems reduce the pain of osteoarthritis."
This news will not be welcomed by the pharmaceutical companies. Big Pahrma stands to lose billions of dollars if its market for arthritis treatments is substantially lost. Sixty-six million Americans, nearly one in 3 adults, have various forms of arthritis, the leading cause of disability among Americans over age 15, according to the Arthritis Foundation. Medical prescribers won’t be too happy either, since people with arthritis will be less dependent upon them for toxic drugs and increasingly will be free to obtain low-cost, safe and effective treatments.
The results of a new clinical study presented at the Annual Scientific Meeting of the American College of Rheumatology (November 14, 2005) suggest that the combination of glucosamine and chondroitin sulfate is at least as effective as the prescription drug celecoxib (Celebrex) in treating pain caused by moderate to severe osteoarthritis of the knee.
Glucosamine is a naturally occurring molecule that the body uses to build joint cartilage. Most studies have shown that glucosamine (usually given as glucosamine sulfate) can relieve pain associated with osteoarthritis and slow progression of the disease, presumably by helping to repair damaged joint tissue. Chondroitin, another component of joint cartilage, has also been found to slow progression of this disease and to have an anti-inflammatory effect.
In the new study, 1,258 people with osteoarthritis of the knee were randomly assigned to receive one of the following for 24 weeks: 500 mg of glucosamine (in the form of glucosamine hydrochloride) three times a day; 400 mg of chondroitin sulfate three times a day; 500 mg of glucosamine and 400 mg of chondroitin sulfate, each three times a day; 200 mg per day of celecoxib, a prescription anti-inflammatory medication; or a placebo. The response rate was defined as the proportion of patients in each group who experienced at least a 20% improvement in pain.
Among those treated who had moderate to severe symptoms, the response rates were 79% with combination therapy, 69% with celecoxib, 66% with glucosamine, 61% with chondroitin sulfate, and 54% with placebo. Only the response rates in the combination-therapy and celecoxib groups were statistically significant compared with the placebo group. However, in the study as a whole, and in the subset of people with mild osteoarthritis, celecoxib was the only treatment found significantly more effective than the placebo. All treatments were well tolerated.
The results of this study suggest that the combination of glucosamine and chondroitin sulfate is more effective than a placebo, and at least as effective as celecoxib, for moderate to severe osteoarthritis of the knee. This combination did not appear to be effective for milder arthritis. Combination treatment was also more effective than glucosamine or chondroitin sulfate alone, but it was not clear whether these differences were statistically significant.
When considering these findings it should be noted that previous research has suggested glucosamine sulfate is more effective than glucosamine hydrochloride. In a sense, the wrong form of glucosamine was used in this study, so additional research is needed to determine whether combination therapy is more effective than glucosamine sulfate alone.
Even when researchers fail to use the recommended forms of nutritional supplements with known efficacy, the results still show that use of drugs with unwanted side-effects and known adverse effects is unnecessary. It is far safer to use these supplements than to use celecoxib (Celebrex). For a comprehensive nutritional based supplement with proven effectiveness and a guarantee, I highly recommend arthrit-eze.
Boehringer Ingelheim and FDA notified healthcare professionals of revisions to PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information for Flomax, indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers including Flomax.
Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned by doctors to ascertain whether they have taken Flomax or other alpha-1 blockers. If so, the patient’s ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.
Doctors were advised by the frug manufacturer as follows.
This communication is to inform you of a surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) that has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers, including Flomax® (tamsulosin HCl). Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases the alpha-1 blocker had been stopped prior to surgery.
In most of these cases, the alpha-1 blocker had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patient had been off the alpha-1 blocker for a longer period (5 weeks to 9 months). IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. Measures such as the utilization of iris hooks, iris dilator rings, or the use of viscoelastic devices such as Healon 5 can minimize the consequences of this syndrome.
FLOMAX, an alpha-1 blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), has been commercially available in the United States since 1997.
Until there is a better understanding of the etiology of this syndrome, it is recommended that male patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken FLOMAX or other alpha- 1 blockers . If so, the patient’s ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure. The benefit of stopping alpha-1 blocker therapy, including FLOMAX, prior to surgery has not been established.
While a definitive causal relationship between IFIS and alpha-1 blockers, including FLOMAX, has not been established, BI has amended the FLOMAX prescribing
information to include a reference to IFIS in the ADVERSE REACTIONS, Post-Marketing Experience section as well as in the PRECAUTIONS, General section.
An updated 20 page PDF document containing full prescribing information is available. Personally, I wasn’t too impressed with some of the sample sizes when it came to studying adverse effects. However, it is quite in accordance with normal practices approved by the FDA. It’s just that I don’t share the FDA’s willingness to treat the patient population (medical human consumers) as though they were experimental subjects.
Novartis Ophthalmics announced it has voluntarily recalled a total of seven lots of two products intended for use in the eye. Novartis Ophthalmics takes its mission of patient care and providing quality products very seriously, and therefore, believes it is necessary to take this precautionary action. The recalls are being conducted with the knowledge of the FDA.
Novartis Ophthalmics is recalling five lots of GenTeal® Gel, a non-prescription drug product used to relieve dryness of the eye.
The five lots of GenTeal® Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004.
The GenTeal® Gel recall is being conducted following concerns regarding sterility of the product made for Novartis by a contract manufacturer. Additional sterility tests were conducted on several lots of GenTeal® Gel. Test results indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.
Novartis Ophthalmics is also recalling two lots of GenTeal® GelDrops. The two lots are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005.
The GenTeal® GelDrops lots are being recalled due to a lack of sterility assurance. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal® GelDrops lots are affected.
Consumers who have purchased GenTeal® Gel or GenTeal® GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.
The FDA alert follows.
GenTeal Gel and GenTeal GelDrops
Audience: Ophthalmologists, other healthcare professionals and consumers
[Posted 11/22/2005] Novartis Ophthalmics and FDA notificed healthcare professionals and patients of a voluntary recall due to a lack of sterility assurance of seven lots of two products, GenTeal Gel and GenTeal GelDrops, intended for use to relieve dryness of the eye. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people.The five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004.
The two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005.Test results for GenTeal Gel indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.
So if you use these products please check the details to determine whether you are safe to use your products or should return them. If you know someone who uses these products please pass on the same advice.
Here is an alarming analysis by the Organic Consumers Association of a newly proposed federal regulation regarding the testing of chemicals and pesticides on human subjects. It claims that the impact of these EPA proposals would be to allow pesticide testing on orphans and mentally handicapped children.
Public comments are now being accepted by the Environmental Protection Agency (EPA) on its newly proposed federal regulation regarding the testing of chemicals and pesticides on human subjects. On August 2, 2005, Congress had mandated the EPA create a rule that permanently bans chemical testing on pregnant women and children.
But the EPA’s newly proposed rule, misleadingly titled "Protections for Subjects in Human Research," puts industry profits ahead of children’s welfare. The rule allows for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:
- Children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.
- Parental consent forms are not necessary for testing on children who have been neglected or abused.
- Chemical studies on any children outside of the U.S. are acceptable.
OCA’s focal concerns with this proposed rule specifically involve the following portions of text within the EPA document (Read the full EPA proposed rule here: PDF — HTML):
70 FR 53865 26.408(a) "The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent…If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement…"
(OCA NOTE: Under this clause, a mentally handicapped child or infant orphan could be tested on without assent. This violates the Nuremberg Code, an international treaty that mandates assent of test subjects is "absolutely essential," and that the test subject must have "legal capacity to give consent" and must be "so situated as to exercise free power of choice." This loophole in the rule must be completely removed.)
70 FR 53865 26.408(c) "If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements…"
(OCA NOTE: Under the general rule, the EPA is saying it’s okay to test chemicals on children if their parents or institutional guardians consent to it. This clause says that neglected or abused children have unfit guardians, so no consent would be required to test on those children. This loophole in the rule must be completely removed.)
70 FR 53864 26.401 (a)(2) "To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research…"
(OCA NOTE: This clause is stating that the Administrator of the EPA has the power to completely waive regulations on human testing, if the testing is done outside of the U.S. This will allow chemical companies to do human testing in other countries where these types of laws are less strict. This loophole in the rule must be completely removed.)
70 FR 53857 "EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient human research is found to be crucial to EPA’s fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study covered by proposed § 26.221 or § 26.421–i.e., an intentional dosing study involving pregnant women or children as subjects…"
(OCA NOTE: This clause allows the EPA to accept or conduct "ethically deficient" studies of chemical tests on humans if the agency deems it necessary to fulfull its mission. Unfortunately, the EPA report sets up no criteria for making such an exception with any particular study. This ambiguity leaves a gaping loophole in the rule. Without specific and detailed criteria, it could be argued that any and every study of chemical testing on humans is "necessary." This loophole in the rule must be removed, based on this inadequacy of criteria and definition.)
Provided by Organic Consumers Association on 11/20/2005