The Appliance of Science
keegan asked:
And now for the perhaps shocking news: there are times when Viagra, Cialis and Levitra are of no help at all for treating erectile dysfunction. You have all been persuaded to believe that Viagra and the other PDE-5 inhibitors will always be able to help, even if only a little. Unfortunately, that’s not true. There are times when the degree of damage is too great for a “natural” solution. And let’s be clear. In relative terms, the use of Viagra and the others allows the body to respond to sexual stimulation as it was designed to do. Viagra simply removes a physical barrier to a natural ********.
This means we are into the surgical options. The first to mention is vascular reconstructive surgery. In a small number of cases, the surgeon may be able to reconstruct the arteries so that blood will flow more freely into the corpus cavernosum. Alternatively, surgery may help those suffering from venous leakages. When the blood inflates the corpus cavernosum, it compresses the veins that allow the blood to drain out of the *****. If the compression is inadequate, the blood will not be retained inside the corpus and the ******** will deflate. Unfortunately, the surgical theories have mostly failed in practice. Only about 5% of those having reconstructive surgery have found improved performance. This surgery is expensive. It is a long and difficult operation, and any incision can cause nerve damage. So it is not often used today.
Thus, when all else has failed or is not acceptable for some reason, we come to the somewhat radical solution of implanting a penile prosthesis.
How does this work?
There are three tubes in the penile shaft. Running along the bottom of the penis, the urethra drains the urine from the bladder out of the body through the *****. Along the top of the penis, the two more substantial tubes run side-by-side. They are designed to work in much the same way as the tyre on a car, i.e. with an inner and outer tube. So when the inner tubes fill with blood, they push against the outer tubes and, as the volume of blood increases, lift the ***** into an erect position.
Since the 1930s, medical researchers have been experimenting with implants to mimic this process of inflation and create the effect of an ********. We therefore have more than seventy years of experience among more than one million men to draw on. Two different approaches have come to dominate. One range of implants remains semi-rigid. These devices are easy to implant and very rarely fail mechanically. The problem, however, is that they produce a permanent ******** which can be difficult to conceal. Although they may be flexed up and down, most have limited mobility. The Dura II manufactured by American Medical Systems (AMS) has a more sophisticated system relying on interlocking disks strung on a central cable under tension which offers greater control over positioning, but may have an increased risk of mechanical failure.
The others are hydraulic, e.g. Dynaflex and CXM, and inflate, relying on a pump contained inside the ******* to transfer fluid (almost always water) from a reservoir inside the abdomen. These devices may have:
1.one, rod-like inflatable chamber which is hinged;
2.a two chamber system, e.g. the Ambicor; or
3.a three chamber system. All these systems replace the original corpa cavernosa. Today’s three-piece inflatable devices produced by AMS and Mentor Corporation offer flaccidity and ********* that approach the natural state. Whichever system you opt for, you should expect some pain and discomfort for five or six weeks following surgery. And, once installed, the implants cannot replace the “real thing”. Thus, if you have already lost your libido, it will not return. Similarly, if the nerve damage had caused a loss of sensation, or you were unable to achieve ****** or ejaculation, prosthetics will not restore those functions.So what are the advantages of this technology? Well, when the oral medications such as Viagra, Cialis and Levitra have failed, the convenience factors of the alternatives become important. Implants are safe and work no matter what the original cause of the ED. They are particularly useful to treat cases of damage following priapism and Peyronie’s Disease, fibrosis after injections, and to restore function after surgery for prostate cancer. So long as the partners are counselled on the strengths and weaknesses of the systems available, they provide satisfaction in more than 90% of all cases. Once installed, there are no further costs and they require no further maintenance (only about 3% of all installed devices ever need attention). From a psychological point of view, there is no external equipment to distract — as in the case of injections and vacuum devices. Equally, there is no need to remember to bring the Viagra, Cialis or Levitra along. If you are in the mood, you can simply act without having to wait for the medication to take effect.
Nevertheless, there are disadvantages to consider. This is a once-and-for-all procedure. Once the implant has been installed, it is no longer possible for a natural ******** to occur. It is always possible that, as science develops, different non-invasive procedures may become available. One may solve the ED problem you have. If your view is that a more natural form of treatment is better, then you may decide to wait. On the issue of informed consent, there are always risks in surgery involving an anaesthetic. In particular and despite a coating of antibiotics to modern implants, you will learn there is a small risk of infection following the surgery. This is relatively rare, but if it does occur and irrigation fails, the only response is to remove the prosthesis. However, once installed, there are three more general complaints.
1.Because the ******** is not being caused “naturally”, the systems only produce hardness in the body of the *****. Neither system affects the head of the ***** which remains soft. This can feel unsatisfactory and make *********** uncomfortable.
2.The body of the ***** does not warm as in the natural ******** which can feel strange to your partner.
3.The surgery can sometimes produce a shorter ***** which you and your partner may find unsatisfactory.
Finally, let’s dispose of one more general worry that some of you may have. There have been a number of problems with the safety of some silicone implants, e.g. in ****** enhancements. None of the inflatable prostheses use any form of silicone as the fluid.
And now for the perhaps shocking news: there are times when Viagra, Cialis and Levitra are of no help at all for treating erectile dysfunction. You have all been persuaded to believe that Viagra and the other PDE-5 inhibitors will always be able to help, even if only a little. Unfortunately, that’s not true. There are times when the degree of damage is too great for a “natural” solution. And let’s be clear. In relative terms, the use of Viagra and the others allows the body to respond to sexual stimulation as it was designed to do. Viagra simply removes a physical barrier to a natural ********.
This means we are into the surgical options. The first to mention is vascular reconstructive surgery. In a small number of cases, the surgeon may be able to reconstruct the arteries so that blood will flow more freely into the corpus cavernosum. Alternatively, surgery may help those suffering from venous leakages. When the blood inflates the corpus cavernosum, it compresses the veins that allow the blood to drain out of the *****. If the compression is inadequate, the blood will not be retained inside the corpus and the ******** will deflate. Unfortunately, the surgical theories have mostly failed in practice. Only about 5% of those having reconstructive surgery have found improved performance. This surgery is expensive. It is a long and difficult operation, and any incision can cause nerve damage. So it is not often used today.
Thus, when all else has failed or is not acceptable for some reason, we come to the somewhat radical solution of implanting a penile prosthesis.
How does this work?
There are three tubes in the penile shaft. Running along the bottom of the penis, the urethra drains the urine from the bladder out of the body through the *****. Along the top of the penis, the two more substantial tubes run side-by-side. They are designed to work in much the same way as the tyre on a car, i.e. with an inner and outer tube. So when the inner tubes fill with blood, they push against the outer tubes and, as the volume of blood increases, lift the ***** into an erect position.
Since the 1930s, medical researchers have been experimenting with implants to mimic this process of inflation and create the effect of an ********. We therefore have more than seventy years of experience among more than one million men to draw on. Two different approaches have come to dominate. One range of implants remains semi-rigid. These devices are easy to implant and very rarely fail mechanically. The problem, however, is that they produce a permanent ******** which can be difficult to conceal. Although they may be flexed up and down, most have limited mobility. The Dura II manufactured by American Medical Systems (AMS) has a more sophisticated system relying on interlocking disks strung on a central cable under tension which offers greater control over positioning, but may have an increased risk of mechanical failure.
The others are hydraulic, e.g. Dynaflex and CXM, and inflate, relying on a pump contained inside the ******* to transfer fluid (almost always water) from a reservoir inside the abdomen. These devices may have:
1.one, rod-like inflatable chamber which is hinged;
2.a two chamber system, e.g. the Ambicor; or
3.a three chamber system. All these systems replace the original corpa cavernosa. Today’s three-piece inflatable devices produced by AMS and Mentor Corporation offer flaccidity and ********* that approach the natural state. Whichever system you opt for, you should expect some pain and discomfort for five or six weeks following surgery. And, once installed, the implants cannot replace the “real thing”. Thus, if you have already lost your libido, it will not return. Similarly, if the nerve damage had caused a loss of sensation, or you were unable to achieve ****** or ejaculation, prosthetics will not restore those functions.So what are the advantages of this technology? Well, when the oral medications such as Viagra, Cialis and Levitra have failed, the convenience factors of the alternatives become important. Implants are safe and work no matter what the original cause of the ED. They are particularly useful to treat cases of damage following priapism and Peyronie’s Disease, fibrosis after injections, and to restore function after surgery for prostate cancer. So long as the partners are counselled on the strengths and weaknesses of the systems available, they provide satisfaction in more than 90% of all cases. Once installed, there are no further costs and they require no further maintenance (only about 3% of all installed devices ever need attention). From a psychological point of view, there is no external equipment to distract — as in the case of injections and vacuum devices. Equally, there is no need to remember to bring the Viagra, Cialis or Levitra along. If you are in the mood, you can simply act without having to wait for the medication to take effect.
Nevertheless, there are disadvantages to consider. This is a once-and-for-all procedure. Once the implant has been installed, it is no longer possible for a natural ******** to occur. It is always possible that, as science develops, different non-invasive procedures may become available. One may solve the ED problem you have. If your view is that a more natural form of treatment is better, then you may decide to wait. On the issue of informed consent, there are always risks in surgery involving an anaesthetic. In particular and despite a coating of antibiotics to modern implants, you will learn there is a small risk of infection following the surgery. This is relatively rare, but if it does occur and irrigation fails, the only response is to remove the prosthesis. However, once installed, there are three more general complaints.
1.Because the ******** is not being caused “naturally”, the systems only produce hardness in the body of the *****. Neither system affects the head of the ***** which remains soft. This can feel unsatisfactory and make *********** uncomfortable.
2.The body of the ***** does not warm as in the natural ******** which can feel strange to your partner.
3.The surgery can sometimes produce a shorter ***** which you and your partner may find unsatisfactory.
Finally, let’s dispose of one more general worry that some of you may have. There have been a number of problems with the safety of some silicone implants, e.g. in ****** enhancements. None of the inflatable prostheses use any form of silicone as the fluid.
Life Science Companies and the Fda: How Change Control Software Transforms a Combatant Fist Fight Into a Picnic in the Park
Marci Lynn Crane asked:
When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.
The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?
The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.
Change Control Software: Middle Ground for Two Separate Powers
Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.
The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.
The Problems
Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled 1) manually or 2) with a hybrid/decentralized solution. Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.
Manual and Hybrid Solutions: Problems that Contribute to Greater Problems
Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.
High Costs—Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.
Validation Procedures—The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.
No Centralized Location—A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need—when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.
Document Revision Processes—When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.
Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is 1) customizable to their needs and that 2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.
A Picnic in the Park
Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.
When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.
The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?
The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.
Change Control Software: Middle Ground for Two Separate Powers
Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.
The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.
The Problems
Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled 1) manually or 2) with a hybrid/decentralized solution. Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.
Manual and Hybrid Solutions: Problems that Contribute to Greater Problems
Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.
High Costs—Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.
Validation Procedures—The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.
No Centralized Location—A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need—when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.
Document Revision Processes—When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.
Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is 1) customizable to their needs and that 2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.
A Picnic in the Park
Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.
