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Lab To Market Act idea

jstepp590

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This thread is the second of a three part series on specific ideas for solving our national debt problem. I am a grass roots activist who has come up with specific ideas to solve our fiscal problems and I need input and constructive criticism on the ideas to help me develop them. I am non-partisan, am very well educated on these issues and would not waste your time with anything that wasn't a politically and economically viable solution to these problems.

senescence_modification.jpg

Lab to Market Act



I would like you to meet my two friends from the picture above, one named Mighty and the other Geri. Mighty is short for Mighty Mouse, Geri is short for geriatric. While I am sure that the researchers who raised them have entirely different names for them, the important thing is what those researchers were trying to teach us, that we are on the cusp of some truly society changing technologies dealing with health and aging. The New York Times has an excellent article on this technology at the bottom of the page.



See, both Mighty and Geri died of heart attacks at a very old age. As you can see by the side shots above there was an entirely different result to the way they aged. That result was achieved through a drug that Mighty received that killed off senescent cells before they could do harm to the body as Mighty aged. It doesn’t necessarily make an organism live longer that I have seen but they do live much healthier, and word is that even some disease progressions were halted or reversed from older organisms that were already suffering from aging related disease. This is not snake oil or pie in the sky but real research with results in peer reviewed media. Yet as amazing and critical as such a drug would obviously be in order to get it to market, the approval process could take over a decade and cost up to a billion dollars for each usage for each drug!



This bottleneck doesn’t just affect this type of drug or technology but many of the new advances that could have a significant effect on our budget. Everything from cancer treatments that make multiple pound tumors disappear within weeks, the above mentioned aging related problems or even altered mouth organisms that prevent tooth decay for life. The entry to market getting through the approval process is something I think is slowing our potential.



As has been shown in the lab, we are on the cusp of aging technologies that have been proven to eliminate or reverse many of the serious ailments that afflict elderly organisms since the beginning of life on Earth. These ailments directly contribute to the national debt because of our social programs so from a fiscal standpoint alone this could be incredibly important. Unfortunately, while having FDA regulations are for our protection and have served us well in the past, we are under a time constraint to use these new technologies to produce budget friendly results, with that constraint based on the baby boomers advanced state of age and the impact they will have on our budget. I propose slightly revising the step in between FDA Phase 2 and Phase 3 clinical trials, which is the most costly and time consuming of the three steps to approving a new drug or technology.



It is my intention to create a system that will expedite the ability of these new medical advances to move from the lab and into the market with an experimental category. They will be sold with legal protections for the drug companies for reasons that do not entail fraud, and with the same kind of 10 star rating system most online shoppers are familiar with. These will apply to the company through an aggregate of the products sold under license. Through this mechanism of consumer feedback directly affecting the reputation of the company, the intention is to create a consumer regulated system dependent on the government mainly for fighting fraud. They may be sold before or at the same time as Phase 3 trials and thereby give our citizens more choices in their health care and in a more expedited manner. The drugs will be riskier to take because they haven’t been through the entire Phase 3

research and trials but will be available as an additional voluntary choice that we do not currently have. In order to facilitate this, I propose the following steps:



1. New drugs will be allowed to be sold to the public as an experimental drug once Phase 2 testing is complete and evaluated. Each company that enters a drug or medical technology into the system will create a company profile to which a rating of one through ten stars will be created. Each product sold will have a license and that license will also have a ten star rating system reflecting on itself and the parent company through accumulation of ratings from all of their products.

2. Each drug or technology and its intended use will receive a license. Drug companies are allowed to advertise a drug for a single use per license. If a drug has multiple uses, then that drug and each use will be covered under an individual license.

3. The FDA will create a page or series of pages that links to their main U S Food and Drug Administration Home Page page. It will post the license information for drugs/technologies and will ensure all information for any experimental drug/technology is posted promptly, fully and accurately. FDA will be responsible for making sure that no fraudulent activities are permitted such as posting disinformation or not posting all information the customer needs to make the most informed decisions they can. Ten star ratings for all companies using the system are posted as well as ten star ratings for each license. A section will be provided by the government where the medical researchers and patients can interact, minimum as a chat and preferably voice/video conferencing. A section will be provided that ranks the drugs/technologies based on stars averaged as well as one where the FDA medical staff can post pertinent comments, both positive and negative, at no risk or censure to themselves.

4. Pharmaceutical companies will be protected from any lawsuits that do not entail fraud or disinformation for any new drug or technology sold under experimental status. Fraud or disinformation will also result in loss of that company’s privilege to use the system for no less than five years and will be duly noted in red in that companies scoring and profile seen by citizens on the FDA website. Not every incident will require that drastic of action, but it should be enforced in the case of willful deceit or harm for profit. FDA administration will determine if the incident warrants this administrative action.

5. Each experimental drug purchased will be required to be distributed under the supervision of a doctor through prescription. As part of that prescription both the patient and doctor should have to register with the FDA page so that their experiences and results are tracked and rated. Make this registration and tracking a requirement for using the system. This gives citizens a place to register their experiences for everyone to read and facilitates citizen regulation of the drug companies. Keep it informative but not onerous for the patient and their doctor to fill in.

6. Drug company medical researcher(s) will be assigned for each license to ensure proper use of this experimental drug/technology, develop feedback and working knowledge. They are to have direct access to consumers and vice versa while license is in experimental status.

7. We will not determine how much pharmaceutical companies will charge, whether free or expensive. It is their property after all. If the FDA website has a low rating for the company then they shouldn’t expect much.

8. Any cost incurred by the government will be fully covered by the cost of the entrance fees paid for the license. This process should be zero sum for government expenses using this, no more and no less fees than required. The company may then pass those costs onto the consumer from there if they need to, but this will still be significantly less expensive for them than full Phase 3 trials would be so it is still heavily in the company’s best interest compared to the current system.

9. The only role the FDA will play in this process is to determine whether all information on this drug is fully disclosed, readily available and accurate and determine whether the incidences that will arise are significant enough that they need to lock the company out of this market for five years. If they need to they should not hesitate, not just to protect the integrity of the system but also for the safety of the consumer. Regardless, with consumer regulation any bad practices would tend to have bad effects on the company’s bottom line since we will vote with our wallets based on their score.

10. Toxicity or negative effects must be listed and all information on those effects must be fully disclosed before the drug can continue to be sold. The reasoning behind this is that if a person is facing an incurable disease with 100% chance of them dying a horrible death, and they have a chance to take a drug that is 30% likely to kill them and only 10% effective it is still a better chance than what they had before. I would not want to take that choice away from them, but would want them to have all the information possible to make that decision with.

11. Each drug will be subject to a limited amount of time or uses under its experimental status but eventually Schedule 3 testing will be required to continue marketing the drug.

12. The use of live organisms such as oncolytic viruses or microbes for different purposes show some amazing progress and have had quite a few successes. The main fear is releasing organisms that are capable of infecting people other than the intended recipient. These should be regulated by the FDA to make sure that the organisms will not spread beyond the intended patient. That they cannot keep it contained or work out a procedure to keep it contained should be the only bar to market from a government entity. If it is not contagious it should be allowed even if there are potential side effects.

13. If a truly promising drug or technology comes out that could have a major effect on our debt situation the government is allowed to purchase it through consent and open it to the generic market as a way to cut costs. Cost benefit analysis that is fully transparent and peer reviewed should be required before the government may spend the taxpayer’s money on it.





Intended Results:

It is my determination that one of the best ways to lower our projected debt is by keeping our citizens as healthy as possible up to the very end, which is a win-win situation for everyone.



Using this system, it should be possible for us to take advantage of the biomedical industry’s revolution in time for it to have an impact on our aging citizens’ health as well as our projected debt. It allows the citizens and their doctors’ control over the success of a product on the market with minimal cost or risk to the product developer and without creating more government bureaucracy. It also allows us to regulate the company producing the drug or technology ourselves so that we are not having to depend on government regulation.



The financial burden for this system is minimal and is borne by the companies that are taking advantage of it and therefore doesn’t add to the debt or place a further strain on government services. It also lowers the barriers to entry and should keep government red tape and regulatory costs from barring smaller companies from competing with larger companies.



*

Scientists Have Silver Bullet To Kill Multiple Cancers, Human Trials Starting : US/World : Medical Daily

Cancer Drug That Shrinks All Tumors Set To Begin Human Clinical Trials

Old mice, young blood: Rejuvenating blood of mice by reprogramming stem cells that produce blood

Genetically Engineered Immune Cells Found to Rapidly Clear Leukemia Tumors: Scientific American

Evidence supports blocking immune response to enhance viral therapy against solid tumors

Will Genetically Modified Bacteria End Dental Cavities?

New study validates longevity pathway: Findings identify universal mechanism for activating anti-aging pathway

Virus shows promise as prostate cancer treatment

http://www.nytimes.com/2011/11/03/s...-can-be-purged-mouse-study-suggests.html?_r=0

Revved-Up Protein Fights Aging in Mice | Wired Science | Wired.com
 

jstepp590

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Ok this thread seems to be done. The only negative I have heard is that we should exclude pregnant women because of a drug in Europe that was approved too early. It was used for some of the physical discomfort effects of pregnant women and caused their children to be born with feet and hands but no arms or legs, basically flippers. I am updating my website to reflect that because I absolutely agree. Thank you for the people who reviewed this idea.
 

Blue_State

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Just a note. I assume 90% of the people on this site will not read an initial post that is that long. At most one to two paragraphs. There is simply too much information to have a discussion about in your initial post. I recommend you post the core concept and a link to supporting information. That will generate discussion.

Good luck.
 

jstepp590

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Just a note. I assume 90% of the people on this site will not read an initial post that is that long. At most one to two paragraphs. There is simply too much information to have a discussion about in your initial post. I recommend you post the core concept and a link to supporting information. That will generate discussion.

Good luck.

I think you're correct, which means I am either in the wrong forum or need to change the format.
 

jstepp590

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I was done at three part ... something

:lol:

Some people do not like to read and would rather see the movie. Not much I can do about that, these ideas require reading and critical thought.
 

blaxshep

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:lol:

Some people do not like to read and would rather see the movie. Not much I can do about that, these ideas require reading and critical thought.

True and I am all for that, I just don't expect that level of thought on a forum. lol.
 
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