Getting to the Heart of New Drugs

New Drugs and Research You Should Know



True Breakthrough Publications: 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on Prescription Fish Oil, focus on Vascepa. Breakthrough new information from the REDUCE-IT study found a 25 % reduction in heart attacks versus other medicines and this was in a group of heavily pre-treated patients. Click here to pre-order or order 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on Invokana. The CREDENCE study was actually stopped early because diabetes medicine worked too well. This is a very unusual occurrence and the full results will be released at an upcoming scientific meeting. Click here to pre-order or order 

New: November 6, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on evolocumab. Breakthrough new pricing giving a 60 percent reduction in cost is a game changer for the first PCSK9 type cholesterol medicine. This important family of medicines has been underutilized up til now because of the price. Our new eBook explains the new pricing and gives the full Repatha picture. [ Coming soon ]

New: November 7, 2018: Pre-orders for The Essential Guide To Prescription Drugs, Update on rivaroxaban. Breakthrough research shows that this medicine, when combined with aspirin, lowers Major Adverse Cardiac Events (MACE) decreasing the probability of CV death, MI and strokes in people with CAD or Pad. Click here to pre-order or order

True breakthrough Criteria: What criteria will we use? 

1)     The medicine is the first in a new medicine family (class)…what the FDA would calla novel therapeutic entity (visit www.FDA.gov). A good example here would be evolocumab (Rapatha), the first member of the PCSK9 inhibitor family which was approved.
2)     The medicine is 20% or more effective in treating or preventing a prevalent disease or condition than prior medicines. For example, the new prescription fish oil(Vascepa) which was found to prevent heart attacks by 25% in people who were already being treated with statins.
3)     The therapeutic concept targets a novel path or uses a novel approach to modify or prevent or cure disease. An example here would be signal transduction inhibitors such as Gleevec (actually turns off a gene to cure stomach cancer) or immune-based therapies such as ipilimumab (Yervoy) for melanoma. CRISPER technology seeking gene-based cures.
4)     New guidelines which radically change current practice, incorporating new approaches to monitoring therapy or preventing disease. A good example here is the 2018 American Diabetes Association standards of care.
5)     A company making a medicine develops a program or radical pricing which confers new access to care or enhances outcomes (results) by 15% versus other approaches or therapies. The latest example here is the company Amgen and the medicine Rapatha. The company decided to lower the cost of the medicine by 60%, which is expected to give huge increases in access to a very effective cholesterol medicine.
6)     A new medicine results in CURES of a particular disease or condition where none was previously available. A great example here is the hepatitis C treatments(Harvoni, others) which can result in CURE of the hepatitis C.
7)     A laboratory, clinic or point of care test that improves the ability to diagnose or predict a disease or condition which either could not be previously reliably predicted.
8)     A medicine, vaccine or mechanical device that PREVENTS a disease or condition to a significantly greater degree than previously possible or which addresses a disease or condition previously perceived as a natural course of aging or which was not able to be prevented. A great example here is the new Shingles vaccine. 

Real medicine, real research,really important. The Essential Guide to Prescription Drugs is always there for you! References

1.     FDA www.fda.gov
2.     NIH 
https://nccih.nih.gov/research/statistics/2007/camsurvey_fs1.htm. Updated September 24, 2017. AccessedSeptember 10, 2018.
3.     The Use of Essential Drugs. World Health Organization,
apps.who.int/medicinedocs/en/d/Js2281e 
4.     Accessed10 31 2018. 
http://sitn.hms.harvard.edu/flash/2014/crispr-a-game-changing-genetic-engineering-technique/  

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