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Questions that a homeopath might ask regarding clinical trials today.

1. When designing trials what types of patients should enter and be screened to enter trials? Are these designed to help early, middle and late stage of disease patients? What is the reasoning for the drug companies and researchers to make such selections?

2. What is considered "Well Tolerated?"

3. What expectations for outcome do these clinical trials regard as positive? 

4. How do clinical trials regard and treat 'side-effects?'

5. How are drugs designed to target a disease?

6. Why are drugs synthetic as opposed to natural in origin?

7. At what point does a drug company decide to shut down a clinical trial or move forward?

8. Who is involved in decision making? Patients, manufacturers, researchers? 

9. Does conflict of interest exist in these patent designs?

10. Do they retest old drugs that have proven their worth?

11. What does 'reformulation' mean?

12. How do clinical trials differ from homeopathic provings?

13. What is the cost to benefit ratio? 

14. How long does it take to develop a new drug from R&D to market?

15. Is it ethical to push drug marketing along faster than the normal trial?

16. What is considered a safe drug?

There are probably more questions that come to mind. I started this conversation because Diabetes is at epidemic proportions around the world. Drug manufacturers look to solve this problem by giving drugs, rather than improving diet and making lifestyle changes, where they could invest millions of dollars into educational programs and care centers to provide meal preparation, nutritional guidance, mediation classes, along with stress reduction and exercise. This would drastically reduce the number of people with diabetes without taking drugs for a lifetime. 

We will continue to build this list. 

 

The New York Times recently reported the end of a drug trial on a diabetes drug. 

Wikipedia | Taspoglutide is a glucagon-like peptide-1 analog drug under investigation for treatment of type 2 diabetes being co-developed by Ipsen and Roche.[1] [2] Two phase II trials reported it was effective and well tolerated[3].
Of the eight planned phase III clinical trials of weekly taspoglutide (4 against exenatide, sitagliptin, insulin glargine, and pioglitazone) at least five were active in 2009.[4] Preliminary results in early 2010 were favourable.[5] (At least one of the 8 planned phase III trials had not started recruiting by end 2009.[6])

Medical News Today |  Roche and Ipsen's investigational type 2 diabetes drug taspoglutide (R1583) has been shown to provide significant improvements in glucose control and weight loss after only eight weeks of treatment(1,2) with a safety and tolerability profile that supports entry into Phase III. Taspoglutide, originating from Ipsen's research, is the first human once weekly glucagon-like peptide-1 (GLP-1) analogue. It is a compound similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. Based on these promising Phase II results presented at the American Diabetes Association (ADA) meeting in San Francisco, Roche has made the decision to move taspoglutide into Phase III clinical trials with the program anticipated to start in the second half of 2008.

After Adverse Effects, Roche Ends Trials of Diabetes Drug
By REUTERS
The drug maker Roche has stopped giving patients its experimental diabetes treatment taspoglutide in late-stage clinical trials because of a high rate of adverse reactions, a major blow to a drug once expected to have $2 billion-a-year potential.

Roche said on Friday that the decision was based on a higher-than-expected rate of discontinuations because of gastrointestinal intolerability and as a result of serious hypersensitivity reactions experienced by some patients, according to 52-week data from the trials.

“These discontinuation rates compromise interpretation of the long-term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” Roche said.
A Leerink Swann analyst, Joshua Schimmer, said in a research note that if late-stage dosing had been suspended, “we believe that this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association this year.”
The drug, given once weekly by injection, suffered a setback in June, when it was reported that there were cases of patients’ suffering hypersensitivity reactions to the medicine in clinical trials.

Roche said it was not abandoning its drug, but was considering a reformulation.

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