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From Bioscience Expert Patrick Cox - The Most Life-Changing Book You'll Read This Year - Click Here

August 28, 2017

Dear Reader,

One of the most encouraging trends in health care is the emergence of the “Right to Try” movement. This is an effort to change FDA policies that keep dying patients from getting access to investigational drugs. These are drugs that have gone through initial safety studies but not the entire series of clinical trials.

Right to Try enjoys widespread public and bipartisan support. To date, 37 US states have passed Right to Try legislation. These laws are designed to give dying patients access to therapies that could save or extend their lives. Similar legislation is pending in the other 13 states.

I don’t find these legislative success stories surprising. People dying of diseases that have no approved treatments have little to lose and much to gain from new but unproven drugs. Most people believe that it is wrong to deny those patients access to investigational drugs and the hope they represent.

This becomes quite clear when people are presented with real case studies. The Right to Try website has many examples of terminal patients stymied in their efforts to get promising new drugs. Those involving children are especially heartbreaking.

Removing Regulatory Hurdles

The Right to Try movement escalated to the federal level in January. Senator Ron Johnson of Wisconsin introduced the Trickett Wendler Right to Try Act of 2017. If passed by the House and enacted, it will create faster processes for getting new therapies to terminal patients. It would also create legal immunities for prescribing doctors and biotech companies. This is important because financially pressed biotechs fear ruinous lawsuits that could come about if a patient does not respond well.

The act passed the Senate unanimously. A House version of the bill is now under consideration. A lot is at stake.

Typically, it takes 10 to 15 years for an investigational drug to surmount the regulatory hurdles required for approval. These barriers were put in place decades ago and do not reflect the ability of modern biotechnologies to predict a new drug’s probability of success.

On paper, it’s already possible for patients with life-threatening conditions to get permission to try unapproved therapies. This is called “compassionate use.” But in practice, the process of getting that permission often takes so long that patients run out of time.

Clearly, the public understands the folly of keeping potential cures from terminally ill patients. President Trump supports the reform and Vice President Pence signed Indiana’s Right to Try bill into law in 2015 when he was governor.

I’m hopeful that Right to Try becomes law. It’s not the only way to reduce the regulatory burdens that keep Americans from using better drugs though. Another strategy is reciprocity. This allows drugs that are approved by other developed countries to be used in the US.

A bill to that effect was introduced in 2015. An article in the politically moderate magazine, The Atlantic, did a good job of describing reciprocity. The fact that it was sponsored by Ted Cruz during his bid for presidency may have politicized and ultimately hurt the bill. It died in committee, but the concept enjoys support from across the political spectrum.

The Significance of Metformin

Most Americans seem to be aware that there are effective drugs available only outside the US. Perhaps the most famous example was metformin, which is currently the first-line treatment for type 2 diabetes.

Metformin has been used in the UK since 1958 and was approved by Canada in 1972. But it was not until 1994 that the FDA approved the drug. Privately, many scientists are still angry that the FDA didn’t accept decades of UK and Canadian data instead of requiring domestic trials that yielded the same results.

A trial to prove that metformin is an effective anti-aging drug has been okayed by the FDA, though funding is still lacking. Significant evidence supports the premise that metformin helps prevent many age-related diseases. This includes cancers and heart disease.

I think it would be wrong, however, to blame the people inside the FDA. The political consequences of approving a drug that is later found to be dangerous are too great. Until the agency is relieved of that burden, the FDA will err on the side of caution… even if it kills us.

Metformin is relevant for another reason as well. If the TAME trial is funded, it will create a regulatory pathway for anti-aging drugs. Indirectly, it will confirm that aging is a treatable disease. The regulatory landscape will change but so will peoples’ attitudes about aging.

More and more people will realize that we are all dying of the terminal disease aging. There are, in fact, remarkable anti-aging drugs in labs now. Some, I believe, are so powerful that they will change the entire healthcare industry.

Unfortunately, there are people who will get sick and die prematurely because those drugs won’t be available for 10 to 15 years. These people are being killed by caution.

I believe that even more effective therapies will be developed in the meantime, including some that will reverse biological aging. If you live another 20 years, I’m convinced you’ll live another 50 in good health.

Since we’re all dying anyway, shouldn’t we all have the Right to Try?

Sincerely,
Patrick Cox
Patrick Cox
Editor, Transformational Technology Alert

Mauldin Economics

 

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Jim Webster 38158

Aug. 29, 10:56 a.m.

This article hit particularly close to home for me. 20 years ago I damaged two discs in my lower back. For years I followed ‘conservative’ management, meaning exercise, caution, and drugs only when needed. About a year ago I reached the point of no return. The discs were pretty much gone, and it was bone on bone. I slowly needed more and more pain medication just to function and had given up on most of my activities like mountain biking, hiking, and snow shoeing. I visited neurologists, pain specialists, and surgeons. The solutions I was offered basically came down to do less and take more drugs, or have a two level fusion with a significant risk of blowing out more discs due to adjacent segment syndrome, if I went back to my old activities. Unwilling to accept those options, I did more research. Long-story-short, I am writing this from a hospital in Germany where I just had 2-level disc replacement surgery. Ironically, the disc used was the Spinal Kinetics M6 - an American-invented and made disc. The clinic here has been using it with great success since 2006. The Jurassic FDA just last year approved it for phase-1 clinical trials. Over 50,000 surgeries have been done with the M6. It is infuriating that the FDA won’t simply get the data, review it and approve it. Even at their glacial pace that would take 6 months? But no… Americans will continue to be denied or forced to seek treatment overseas beacause of the arrogant bureaucrats at the FDA. It’s even more infuriating to hear politicians pontificating about health care costs when the entire trip, including travel and nice hotels for both my spouse and I will end up costing vastly less than a sub-standard fusion surgery in the US. I am fortunate enough to be able to bear this cost, since insurance likely won’t. The FDA is long overdue for a complete overhaul.

clarkcpa@bellsouth.net

Aug. 28, 1:03 p.m.

Immunology Laboratories, Inc. (ImmLab) is a very small, closely-held firm that has developed products for the prevention and treatment of Staphylococcus aureus in humans and animals, including Mastitis in dairy cows. Our product is a staphylococcal lysate (SL) prepared by lysis of selected S. aureus strains with selected polyvalent bacteriophages. The selection process is based on many years of research, including testing hundreds of combinations of strains and phages dating back to the 1960s. Based on further research and testing, we are very confident that our products work very well, are non-toxic and are relatively inexpensive to produce.

We have attempted to gain permission to administer our preparation to patients who are dying from MRSA without success.

We are now in the process of reaching out to anyone who may have the vision to realize the worldwide value of this technology and be able and willing to help move our technology forward and eventually get our product(s) to the marketplace. The significance and value of the non-antibiotic products is astounding.

We have completed the discovery and preclinical phases using internal funding only. We have no third-party liabilities or contingencies. However, our immediate challenge is that our available funding has been depleted.

Therefore, Immlab’s stockholders are very interested in forming a mutually beneficial partnering alliance with a firm having the human and financial resources necessary to move forward from here, taking our product(s) through the clinical and approval phases and into the hands of people who can put it to use throughout the world. We feel that an acquisition or merger would be the most appropriate form of alliance.

Our technology is protected by a series of 12 U.S. patents and 10 international patents.

Please visit our website at http://www.immlab.com

Gary Clark, Sec & Treas
Immunology Laboratories, Inc.


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