An Owners' Guide
Pharmaceutical companies are mining your DNA for scientific gold
| Baldness gene Patent pending Columbia University | Alzheimer's gene Patent 5,508,167 Duke University, licensed to Glaxo Wellcome | Parkinson's disease gene Patent pending National Human Genome Research Institution (National Institutes of Health) |
| Brain cancer gene Blindness gene Premature aging gene Asthma gene 
High blood pressure gene Epilepsy gene Obesity gene Osteoporosis gene Melanoma gene |
 |
Glaucoma gene Cardiovascular disease gene Breast and ovarian cancer gene Colon cancer gene Arthritis gene Human Growth Hormone gene Iron overload gene |
Since the early 1990s fledgling genomic companies with enigmatic names such as Progenitor, Millennium Pharmaceuticals, and Darwin Molecular have been pinpointing and patenting human life with the help of $4.5 billion in investments from pharmaceutical companies. The science could lead to cures for cancer and many inherited diseases. But monopoly patents hinder that promise.
Myriad Genetics, for example, found a gene that causes inherited breast cancer and licensed the therapeutic development rights to Eli Lilly. Activists worry that exclusive patent rights over the gene could lead to more expensive gene screening tests and treatments. Patents give companies the right to determine who gets access to genes and at what price. Researchers express concern that exclusive patents will have a "chilling effect" on research and increase medical costs. Biotech companies say patents—and the resulting licensing fees—provide the key incentive for this research. But in Myriad's own corporate literature, the firm candidly admits that its "broad and substantial proprietary estate" of breast cancer genes not only promises huge profits but keeps competitors at bay. "The identification and patenting of genes," notes Myriad, "will present [competitors with] significant barriers to entry."
illustration by Gary Panter
Research provided by the Rural Advancement Foundation International
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Biologics
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tagged as:
- result
Biopharmaceuticals, also known to be in the red biotechnology classification, are specialty therapeutic agents created differently than other typical synthetic pharmaceuticals, and therefore are have a unique molecular complexity that are designed for serious illnesses such as anemia or multiple sclerosis.
Unlike typical drugs, biopharmaceuticals are large complex protein molecules developed utilizing living organisms, such as certain cell. A host cell is manipulated and is inserted into a cell line where it is cultured to produce the desired protein by the manufacturer.
This is a common method of production of biopharmaceuticals.
Because of their uniqueness and exclusivity, they are very expensive- costing thousands a month for the payers, as the manufacturer of such therapies spend over a billion dollars bringing such a biologic to market.
The incentive for the manufacturer is complete exclusivity, as follow on biosimiliars are not authorized as of yet in the United States, yet are in Europe on a case by case basis.
Generic biologics are not possible, as duplication cannot be developed, as all biologics are created with some degree of difference. Also, only about a third of biologic agents make it to market after initiating the development of a particular agent.
Biologic medications began to be used primarily in the 1980s and now this new industry presently make close to80 billion a year- with about 15 percent growth in this market annually, and this is twice the growth of the pharmacetuical industry.
With anemia patients, oncology and dialysis clinics are targets for such meds in this category, as anemia is associated with their treatment and conditions for such diseases. Venture capitalists usually fund the manufacturers of such products produced by new and small manufacturers. Presently, Genentech and Amgen have the largest share of this market.
Yet, some claim that biopharmaceutical products benefit patients to only a certain degree, as they do in fact extend the life of such patients, such as those on chemotherapy or dialysis, but by only a few months. So the high cost of these meds is questionable and has been debated by others.
But again, no substitutes for these products are allowed in the United States, which may explain the very high cost of most biologics. Also, and to some degree, the efficacy of these biologic agents have also been questioned as well in other treatment aspects aside from life extension.
Then there is the issue of fraud with kickbacks and overuse of some of the biopharmaceutical meds used to treat anemia in dialysis clinics in particular. On a few occasions, doctors and clinics have been penalized for overusing the meds and for kickbacks in the form of discounts of the manufacturers.
Ironically, the dialysis process was never patented, yet the many centers that exist have proven to be very profitable, more for some than others.
An example is the situations where dialysis doctors, called nephrologists, have been accused of over-dosing patients with biologic meds to increase their income through their discount arrangement through the manufacturer of such meds, such as those biologics for anemia, and this arrangement is being investigated by regulators and encouraged by the representatives of such meds.
Presently, there are many that approach the FDA to aggressively insist that follow on biologics be allowed into the market for the benefit of these critically ill patients, and this would be of great benefit for such patients, and this can be done, as far as judging such an agent in molecular and biologic terms.
And their efforts have been somewhat successful, as the follow on equivalents of biopharmaceuticals, called biosimilars, could be manufactured and available within the next few years if authorized by this industry’s regulator, which is the Public Health Services Act, a subsidiary of the FDA.
However, this situation of biosimiliar delays illustrates one of many flaws in the U.S. Health Care System- when the sickest have to complicate their illnesses by possible financial stress, such as the case with biologic agents.
Relief is needed, and should be demanded by the public. After all, why be so sick, and then be financially burdened? One solution or suggestion is to either lower the cost of these types of drugs, or allow biosimiliar forms to enter the market faster than what the situation is presently. Recently as well, synthetic biotechnology is speculated to be present in the future.
“A little learning is a dangerous thing.” ---- Alexander Pope
Dan Abshear
Biologics
-
tagged as:
- result
Biopharmaceuticals, also known to be in the red biotechnology classification, are specialty therapeutic agents created differently than other typical synthetic pharmaceuticals, and therefore are have a unique molecular complexity that are designed for serious illnesses such as anemia or multiple sclerosis.
Unlike typical drugs, biopharmaceuticals are large complex protein molecules developed utilizing living organisms, such as certain cell. A host cell is manipulated and is inserted into a cell line where it is cultured to produce the desired protein by the manufacturer. This is a common method of production of biopharmaceuticals.
Because of their uniqueness and exclusivity, they are very expensive- costing thousands a month for the payers, as the manufacturer of such therapies spend over a billion dollars bringing such a biologic to market.
The incentive for the manufacturer is complete exclusivity, as follow on biosimiliars are not authorized as of yet in the United States, yet are in Europe on a case by case basis. Generic biologics are not possible, as duplication cannot be developed, as all biologics are created with some degree of difference. Also, only about a third of biologic agents make it to market after initiating the development of a particular agent
Biologic medications began to be used primarily in the 1980s and now this new industry presently make close to80 billion a year- with about 15 percent growth in this market annually, and this is twice the growth of the pharmacetuical industry.
With anemia patients, oncology and dialysis clinics are targets for such meds in this category, as anemia is associated with their treatment and conditions for such diseases. Venture capitalists usually fund the manufacturers of such products produced by new and small manufacturers. Presently, Genentech and Amgen have the largest share of this market.
Yet, some claim that biopharmaceutical products benefit patients to only a certain degree, as they do in fact extend the life of such patients, such as those on chemotherapy or dialysis, but by only a few months. So the high cost of these meds is questionable and has been debated by others. But again, no substitutes for these products are allowed in the United States, which may explain the very high cost of most biologics. Also, and to some degree, the efficacy of these biologic agents have also been questioned as well in other treatment aspects aside from life extension.
Then there is the issue of fraud with kickbacks and overuse of some of the biopharmaceutical meds used to treat anemia in dialysis clinics in particular. On a few occasions, doctors and clinics have been penalized for overusing the meds and for kickbacks in the form of discounts of the manufacturers. Ironically, the dialysis process was never patented, yet the many centers that exist have proven to be very profitable, more for some than others.
An example is the situations where dialysis doctors, called nephrologists, have been accused of over-dosing patients with biologic meds to increase their income through their discount arrangement through the manufacturer of such meds, such as those biologics for anemia, and this arrangement is being investigated by regulators and encouraged by the representatives of such meds.
Presently, there are many that approach the FDA to aggressively insist that follow on biologics be allowed into the market for the benefit of these critically ill patients, and this would be of great benefit for such patients, and this can be done, as far as judging such an agent in molecular and biologic terms.
And their efforts have been somewhat successful, as the follow on equivalents of biopharmaceuticals, called biosimilars, could be manufactured and available within the next few years if authorized by this industry’s regulator, which is the Public Health Services Act, a subsidiary of the FDA.
However, this situation of biosimiliar delays illustrates one of many flaws in the U.S. Health Care System- when the sickest have to complicate their illnesses by possible financial stress, such as the case with biologic agents.
Relief is needed, and should be demanded by the public. After all, why be so sick, and then be financially burdened? One solution or suggestion is to either lower the cost of these types of drugs, or allow biosimiliar forms to enter the market faster than what the situation is presently. Recently as well, synthetic biotechnology is speculated to be present in the future.
“A little learning is a dangerous thing.” ---- Alexander Pope
Dan Abshear
