Since those days of uncertainty, the disease has ravaged millions, though in its wake followed a continually growing understanding of the virus and how it works.  I remember talking about it in high school several times, mainly, I think, for the purpose of empowering us to make smart decisions as we awakened to new knowledge of ourselves and of our sexuality.  It seemed everyone agreed that the best way to defeat the disease was to be steadfast in our resolve to prevent its spread and continually educate people on how to accomplish this task.

Unfortunately, however, education didn’t always work, and for those that succumbed to the disease, medicine offered many ways to combat its effects.  People soon were able to live many more years than they ever had before, though the illness still lingered in a body that had to be maintained by a cocktail of drugs.  And while both education and drugs are available in abundance in the US, other countries, especially those in Africa, have been much worse off because of the lack of resources.

Perhaps we are finally approaching a time when the disease can be eradicated rather than just held at bay.  Boston.com reported on November 12th that German hematologists Eckhard Thiel and Gero Huetter of Berlin’s Charite Medical University may have developed a method for defeating the full-blown virus.

Dr. Huetter had been treating a 42-year-old American patient living in Berlin for leukemia, which was unrelated to the AIDS infection in his system.  When screening possible donors to treat the cancer, Dr. Huetter remembered a study he read in 1996 that posited that certain people carry a genetic mutation that makes them resistant to the HIV infection.  If a person inherits the mutation, called Delta 32, from both parents, it prevents HIV from attaching itself to cells and spreading throughout the body.  The doctors treating the patient screened 80 donors for the mutation, and found one that both matched the patient’s marrow type and carried the special mutation.

Prior to the transplant, the patient followed a radiation treatment to eradicate his own infected bone marrow cells and disable his immune system.  Because Huetter’s team feared that the drugs might interfere with the treatment, he was also weaned offf his AIDS drug cocktail.  After the transplant and in the 20 months since, the patient has shown no signs of the AIDS virus.  Though researchers and the doctors themselves admit that the results could be no more than a fluke, it does offer hope that a breakthrough has been made in the treatment of the disease.

The thought that we may be approaching a “cure” for AIDS is astonishing.  Have we really made such inroads in 30 or so short years that a treatment could destroy the disease instead of just treat its symptoms?  We haven’t been able to create a “cure” for the cold or the flu (which our bodies can thankfully handle if they’re strong enough), but we’re now approaching a treatment for something that to me seems infinitely more complex and deadly because of its aggressive nature.

Certainly, a better understanding of what happened needs to occur before the method can become an accepted way to treat AIDS, and more research needs to be done in the dangers of this treatment and how they can be negated in the future.  Destroying the patient’s immune system before initiating a transplant of new marrow cells, for example, carries with it a high risk of mortality by itself.  Coupled with the other parts of the treatment, it’s miraculous that this person even survived.

Then again, cures for what afflicts us never come without risks.  Countless cancer patients probably wouldn’t be around today were it not for experimental, risky procedures.  The first heart transplant, artificial heart, or even recent successful face transplant are all examples of risky medical procedures that yielded results that improved both quality and longevity of life for their patients.  It may take some time before the procedure is perfected, but there is no reason that with some genetic research, AIDS can’t be on that list of curable ailments.

Now, if we could only figure out a cure for that common cold.

Studies compared mice born and kept in a sterile environment with no bacteria in their gut against mice born and kept in a non-sterile environment.  Both sets of mice were fed the same amount of food.  The bacteria-free mice stayed skinny while the mice with gut bacteria gained weight.  The reason is that the bacteria in the intestines of the mice raised in a non-sterile environment were able to break down the food and turn it into calories, while the food passed right through the intestines of the bacteria-free mice undigested.

These findings beg the question: can we manipulate the bacteria in our intestines in order to control weight gain or loss?  For more information on the research and its implications, check out the printed article on the NPR website here.

The past few weeks have been rough.  I have a lot of project work going on, and I find myself staying up later and later to try to keep up with it all.  I guess it’s one of the consequences of trying to build a new company, grow a family, and keep in shape.  There just isn’t time to stare blankly into space for a few minutes and recharge the batteries.

I’ve considered trying to make a habit of drinking a glass of wine every night after dinner, but I just can’t get into it.  It is, believe it or not, because of my doctor that I’m even trying; my cholesterol is great (well, my good cholesterol is *too* low), but he feels that one glass of red wine per day is good for the heart and strikes a balance that may have escaped over the course of a hectic day.  What’s not to like about that kind of advice?

The only problem is, a recent study from Wellesley College and Boston University of more than 1800 people found that the more alcohol a person consumed the smaller their total brain volume.  Aging is another factor in decreasing a brain’s size, and it’s this shrinking that has been linked with the progression of dementia, trouble learning new things, memory and cognition.  Based on the information provided in the article published on Boston.com, this seems to be only a preliminary study with more in-depth investigation to follow, but why take a chance?

For some people it’s hard to give up that drink, but it’s even harder to give up smoking.  The same article indicates that giving up such a vice after a hospital stay is up to 65% more effective when patients are provided with anti-smoking counseling both before leaving the hospital and after they arrive home.  The biggest problem, apparently, are the cues of smoking that are much more prominent once someone returns home than while they’re in the hospital, and even those with the best of intentions are apt to fall into old habits once they’re back.  I don’t deny it’s a difficult habit to break, but if the help is there, why not use it?

And it’s apparent that more and more people are refusing the help of vaccinations for their children, especially the flu vaccine.  Another article on Boston.com explores not only the medical implications of skipping out on your flu vaccine this year, but also the social implications.  Two families known to the author had children who died as a result of complications of the flu in their children, and 83 children nationwide died of the disease.  Of those 83 children, the Center for Disease Control and Prevention estimated only about 5 or 10 had actually been vaccinated.  Overall, 36,000 people die every year, close to the same number as those who die from breast cancer.

Author Carey Goldberg describes a concept of “herd immunity,” which essentially strengthens the effect of a vaccine by allowing a group of inoculated people to, in essence, protect one another by preventing an infection from creeping its way throughout each member of the group.  The fewer members of the group that are vaccinated, the weaker the chain, thus giving the flu (or any other virus) the opportunity to break through and begin infecting multiple members of the group.

Dr. Ken Mandl of Children’s Hospital in Boston is cited in the article as saying that children are essentially “little bioterrorists,” because they can incubate and so rapidly propagate a disease among peers, parents and grandparents.  In vaccinating them, you not only protect them, but you protect yourself, your parents and the community.

I thought it was a little harsh to think of my son as a “little bioterrorist,” but thinking back I realized that I have gotten sick much more often than I ever had before I had him…and he’s not even in school yet.  It’s gotten to the point that my wife and I can almost gauge when we’ll get sick based on how he’s feeling.  We’re all even getting over a sinus infection, which he absolutely started, as I write this post.

Unfortunately, I think that parents are paralyzed into thinking that the flu vaccine (and other vaccines, for that matter) could lead to autism in their children, and they therefore don’t take the measures recommended to prevent the infection and spread of these diseases.  I’ve written several posts on this blog about this very topic, the most recent of which is here.  The problem is that the possibility that vaccinations could cause autism has been so ingrained into our public psyche, we believe that the simplest answer, ceasing vaccinations, is the best one.

Jenny McCarthy exacerbates the problem by appearing on popular Hollywood magazines such as US Weekly and telling the story of her son, who suffered from autism but now is cured.  She believes her son’s suffering began when he received his MMR vaccination and had a seizure shortly thereafter.  I feel for McCarthy — I really do — but I don’t believe her belief in the cause of her son’s illness, without being substantiated by fact, should be spread to cause concern among parents already concerned about the best course of action for their children.  A private, informed conversation should be taking place between parents and their doctors, and proper vaccinations should be discussed in great length to determine their necessity and effectiveness.

Maybe I would be less apt to dismiss McCarthy’s conclusions if one of my children were suffering from the disorder.  But then again, maybe not.  I just feel that, given the severity of the diseases against which vaccinations protect us, we put our children in greater danger by not protecting them.  It is starting to bear out with a resurgence of Measles, and based on the information provided in Carey Goldberg’s article, I’m worried influenza will be next.

I know how I feel about it; what about you?  As always, I encourage you to talk to your doctor to make a decision that’s right for you, because it’s a personal decision that involves the saftey of your child.  Decisions should not be based on this new type of McCarthyism alone, with its finger pointed squarely at the vaccinations that were intended to help.

Sequenom is one such company on the list that I found particularly interesting. 

As I approach my mid-thirties, along with many of my friends, I find myself still at the early stages of raising my own familial unit, with future children on my mind.  This is in sharp contrast to the experience of our parents, who most likely at this point were finished with that stage of their lives and had children many years older than ours.  We all have our reasons for starting our families at a time that would be considered “late” by our parents’ standards, but one of the downsides is increased (albeit still small) risk to the baby for Down Syndrome.  Amniocentesis is one of the best accepted methods to screen for this disorder, but it carries with it a risk of miscarriage and can only postiviely identify 70 to 90 percent of the cases prior to birth.  Sequenom, however, has developed a method that could trump amniocentesis at identifying Down Syndrome cases — so far with 100% accuracy in clinical trials — and do so with minimal risk using only a prenatal blood test.

Sequenom’s technology, dubbed SEQureDx(TM), targets fetal DNA circulating in the mother’s blood to examine the genetic status of the fetus.  The first application identified a fetus’ risk for RhD disease, which occurs when the blood of an expectant mother is incompatible with her unborn child.  Jaundice, anemia, brain damage, heart failure and even death can result from the incompatibility, so identifying it early is crucial to taking measures against it.  Showing that it can additionally be applied as a method for testing a fetus for Down Syndrome would be an added incentive for any potential buyers for the company.

I am encouraged by the company’s charter to make “safe, non-invasive prenatal testing available to all women, independent of age and other factors that may contribute to pregnancy complications,” and am hopeful that the knowledge gained in this kind of research could lead to an increased understanding of the kind of defects that could affect the normal development of an unborn fetus.  As parents, knowing in advance how we should be prepared for any difficulties an unborn little one might have is invaluable and gives us the opportunity to prepare for what might be.

The obvious win for any pharmaceutical company that entertains the idea of Sequenom as an acquisition is an increase in the number of parents willing to run the test.  Like many parents, I fear the risks of amniocentesis, despite the information it will give me.  If the risk is mitigated, then wouldn’t more parents do it?  Would it just become part of the standard barrage of tests that expectant mothers are put through?

They say knowledge is power.  Today, we may be having our children later, but we know a lot more about them before they are born than our parents ever did.  Gender, heartbeat, skeletal development, and soon even certain genetic diseases can be safely screened well before the baby is born and steps can be taken to prepare for or even prevent hardship for the child later in life.  But does this take any of the excitement or anticipation out of child birth?  Does knowing any of this information change the way you feel about a child growing inside your wife (or you)?  Or does knowing the information help you prepare to be a better parent?

Your thoughts, as always, are welcome.

Can you guess which agency granted approval and which agency did not?  If you’ve been following the pharmaceutical industry for the past five years or so, then you probably guessed that Bridion was approved by the European Commission (EC) and turned down by the FDA.  And you’d be right.  This isn’t the first time that the FDA has rejected a product that was approved in Europe, but the fact that all signs were pointing toward approval and the fact that the FDA rejected Bridion a mere three days after it was authorized by the EC, makes it a stand-out example of just how cautious the FDA has become.

So why was it a surprise that the FDA rejected Bridion? 

First, Bridion (or sugammadex by its generic name) is seen by many as a breakthrough drug in the anesthesia field.  Its manufacturer, Schering-Plough, states that “it was specifically designed to reverse within minutes both moderate and deep muscle relaxation induced by rocuronium or vecuronium during general anesthesia. As a result, BRIDION can give anesthesiologists greater control in managing the depth of muscle relaxation through to the end of a surgical procedure.”  The drug is able to quickly reduce paralysis induced by anesthesia, allowing doctors to take the patients off breathing tubes in less time and reduce the side effects of being “under” for a long duration, such as undetected loss of oxygen.  In clinical trials, Bridion showed an ability to reverse muscle relaxation with a median time under 3 minutes, up to 9 to 12 times faster than neostigmine with glycopyrrolate.

Second, the safety risks had not raised any eyebrows during clinical trials.  The most commonly reported adverse effect was a metallic or bitter taste.  Some patients experienced anesthetic complications, such as limb movement or coughing during surgery, or unwanted awareness during anesthesia. Other patients experienced allergic reactions, but these reactions did not appear to be any worse than the reactions caused by the most commonly used anesthesia drugs today - neostigmine and succinylcholine.  In many physicians’ views, the benefits of faster paralysis reversal far outweighed these safety risks.  In fact, the advisory committees for both the FDA and EC performed their respective benefit/risk analyses and gave their recommendations for marketing approval.

Regardless, on August 1, 2008, the FDA rejected Bridion citing concerns about “hypersensitivity and allergic reactions” to the drug.  The agency raised no concerns about the drug’s effectiveness. Meanwhile, the first post-marketing patient was treated with Bridion in Sweden last week. The physician reported that the patient experienced reversal from the muscle relaxant used during surgery in just two minutes.

Schering-Plough plans to move forward with its plan to market the product in the U.S., and perhaps the authorization will go a little smoother after the FDA allows the Europeans to be their test subjects for a little while.  Maybe the U.S. will see Bridion soon… or maybe not.  We’ll have to wait and see.

On September 3rd, CNN posted an article which casts further doubt on Wakefield’s theory, punctuated by the fact that his co-author, Irish pathologist John O’Leary, is also a co-author on the new study. Published in the peer-reviewed journal of the Public Library of Science, PLoS ONE, the new study concludes that the MMR vaccine causes neither autism nor gastrointestinal disorders, adding to a growing body of evidence against the claim.

Wakefield’s original theory attempted to establish that in some children, the measles virus used in the MMR vaccine would grow in the intestinal tract of some children, leading to inflammation that would make the bowel porus. Toxic material would then seep from the bowel into the body, affecting the nervous system and causing symptoms of autism. John O’Leary and the rest of the new study’s team of investigators replicated Wakefield’s experiments in the same lab that was used for the original analysis, using samples from 38 children with bowel disorders, 25 of whom had autism. They found that only one child in each group had trace amounts of the measles virus in their samples.

Further, there was no evidence that there was a relationship between the children showing symptoms of autism or GI disorders and timing of the vaccine; the three events appeared to be independent of one another.

For the researchers involved in the study, along with many who have read the study itself, the evidence appears to be conclusive. Even the vice president for scientific affairs of “Autism Speaks,” an advocacy group, indicated he believed the results were indisputable. However, other organizations such as the Autism Society of America and the National Autism Association feel that further study is needed and that the PLoS ONE study may even be flawed.

What is more frightening to me, however, is the fact that all of this is causing a decline in the number of parents opting for vaccinations for their children. While I can understand one’s trepidation (just the thought of managing a child with autism is something that unnerves me) the fact is that this kind of decision is now starting to play out in statistics within the US. Measles levels are at their highest in more than a decade, with nearly half of those involving children whose parents rejected vaccinations, according to another CNN report on August 21st.

The number of cases reported this year is still relatively small at 131 through July, but doctors are worried because this is already over triple the 42 cases that were reported for all of last year. The disease is no longer endemic to the US, but is brought in from people visiting from other countries or students studying abroad. Once it gets here though, proliferation of the disease in children has been held in check, widely credited to the aggressive childhood vaccination rates.

But what happens when those vaccinations are undermined by information linking them to autism? You put parents in a very precarious situation. A decision as to whether they should defend their children against diseases that can kill by using vaccinations, or defend their children against what can be a debilitating social disorder that is autism. Unfortunately, because we’re dealing with the health and safety of children, any study is discredited by its detractors and the result is almost a political debate where the burden of proof falls not on the person presenting the evidence, but on the person listening, having to waddle through technical and medicinal jargon that they may not understand.

Ultimately, I believe it comes down to the trust that you have in your doctor, and the trust that you have in yourself as a parent. Being able to prevent your child from having to live with autism would be a wonderful thing, but I don’t personally believe that there’s enough evidence to indicate there is a way to prevent it. Vaccinations, I believe, are a red herring in this case and divert our attention from the real cause of the problem. But before we can move forward, we’ll need to find certainty in a study that will help us all move on and fish for something else.

TA-CD essentially works just like vaccines that are used to fight traditional diseases (such as tetanus or the mumps). It gets the body to recognize cocaine as an invader and uses the body’s immune system to prevent the cocaine from doing what it normally does: get the user high. 

As we know, the body doesn’t normally treat cocaine as a harmful trespasser, so TA-CD pairs deactivated cocaine molecules (norcocaine) with deactivated cholera toxin molecules.  The body recognizes cholera as an enemy, and since it is paired with cocaine molecules, the body builds anti-bodies to fight both foreign substances.  The anti-bodies bind to the cocaine molecules, and the resulting bound molecules become too large to enter the user’s brain.  As a result, the patient does not feel the high associated with cocaine use.  In other words, the patient builds immunity to cocaine.

Celtic reports that it completed four Phase II trials with 161 patients prior to 2007 and a larger Phase II trial was slated for 2007.  Preliminary results from the Phase II trials showed efficacy (an increase in cocaine-free days) in a significant number of patients in the treatment group (see the article in Medical News Today for more information).

Of course, Celtic does not plan to lobby to get TA-CD introduced into the list of common childhood vaccinations just yet.  They intend to market the product to assist in the fight against cocaine addiction.  Celtic reports that 800,000 patients in the US attend in-patient programs and out-patient clinics seeking treatment for cocaine addiction, and more than 95% of all cocaine addicts who try to quit relapse.  This is a significant patient population that can benefit from this product.  Along with counseling and the support of family and friends, it will be a tool to help addicts quit. 

Further back in Celtic’s pipeline is TA-NIC, a nicotine vaccine.  If TA-CD is successful, it may pave the way for TA-NIC as well.  It’s not hard to imagine a full suite of vaccines against our pharmacological vices (marijuana, MDMA, heroin, crystal meth, etc.) on the market some day.

I’ll be looking for answers to some of the following questions in the Phase III studies: 

• How long will the vaccine last before a booster dose is needed?
• How many patients will overdose because they increase their cocaine intake in hopes of overwhelming the anti-bodies and getting their high?
• How many patients will switch to another drug (e.g. methamphetamines) to get their fix?

And if the product makes it to market, how will our society react? 

• Will addicts really submit to the vaccinations if the product promises to kill their high for, say, 10 years like a tetanus shot? That’s a big commitment for an addict - there’s no turning back.
• Will parents vaccinate their children against cocaine?
• Will employers require their employees to be vaccinated?
• How will cocaine producers innovate in order to retain their business?

This is an interesting product to keep an eye on.  Your thoughts and comments are welcome.

I was packaged April 28, 2008, in Puerto Rico. My Batch Number is AA6-73P008. I will expire on January 15, 2012. I am associated with 2-D barcode KBDCHDH1528. I was packaged for distribution in Canada. I can tell you as much information as you design me to tell. My codes are undetectable to the human eye so no one can copy me. I am traceable anywhere in the world. I will tell you and only you this information. And I can tell you all of this for less than a penny. (Image published with permission)

So read the ad for NanoGuardian, a state-of-the-art protection system against those who would hope to counterfeit real drugs for a quick profit, or divert real drugs from their intended destination. I found it in the August 2008 issue of Pharmaceutical Executive magazine and was so intrigued by the concept that I had to find out more. So I took note of the web site and immediately started an investigation.

The technology that makes tagging this pill possible, NanoEncryption(TM), was developed by a company named “NanoGuardian (a division of NanoInk).” Using this method, as the ad implies, pharmaceutical companies can add an invisible layer of encrypted data to each dosage of their medications, linking it to an authentication at every stage of their supply chain. Only special tools can actually decipher this code, which links the dose to the package using a proprietary nanolithographic encryption on the dose itself, and Radio Frequency ID tags (RFID) and bar codes on the package. Therefore, if the pill is separated from the package before it reaches the patient, there’s a way to find out.

The technology probably couldn’t have come soon enough, given the growing counterfeit market out there. Email marketing from dubious online pharmacies, which I explored on this blog before, is just one of the many ways these groups can hawk their bogus wares. To me, the biggest concern isn’t even the lost revenue that counterfeiters cause the pharmaceutical companies in creating these fake pills, which NanoInk estimates around $35 billion worldwide. The biggest problem are the patients who are getting their hands on these drugs and endangering their health by taking them.

The process does not chemically alter the drug, and implementing the technology in the manufacturing process requires minimal changes. In fact, a client of NanoGuardian has already submitted a plan to the FDA to implement brand protection through use of the product and has been approved. It wouldn’t surprise me, if this first implementation can be executed successfully, to see other companies start publicly touting the added protection they’re giving patients who rely on their products.

The whole thing actually reminds me a little of a story that came out earlier in the year, where a Silicon Valley company, Gemory, had developed a process for permanently inscribing microscopic versions of photos on a diamond. But while their process may be a novelty and something that is a luxury for people with the money to do it, NanoGuardian’s product seems to be almost a necessity.

The one thing that’s unclear to me is exactly how the patient ends up being protected in this process. The web site for the company is clearly designed to “sell” the product to the industry, which it completely should be. But how do I know as a consumer that what I’m buying is a legitimate drug? The NanoGuardian site indicates that the encryption can only be detected using specialized equipment at the NanoGuardian Authentication Centers…but does that mean that as a consumer I have to send my drugs there before using them? Do pharmacies need to authenticate their medications before stocking them on their shelves? And if it’s not a requirement, what is the impetus for sending the drug for authentication in the first place? If counterfeiters are really good enough to make drugs that look nearly identical to the product they’re duplicating, how would I know that I even need to authenticate? And what’s the cost of authentication? Putting the information on the pill may not cost much…but ensuring a pill has the right information before it reaches the consumer? What does that cost?

I’m sure some of these questions are obvious to some that are entrenched in the industry and familiar with the supply chain. And maybe my brief exposure to the process is naive in that I’m thinking the authentication will be applied in a singular place in the process. I’d love to understand this process more, and would welcome comments from anyone who understands its application better than me. In the meantime, I look forward to seeing the first real products that can ensure their quality because of the tiny writing on the pill.

According to the FDA, in order to be considered a “botanical” product, a drug must have the following characteristics:

• A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof.
• A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection.
• Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug product. (1)

Headquartered in Jamesburg, NJ, Phytomedics was launched in 1996 to focus on such botanical drug products and has partnered with the Biotech Center at Rutgers University for its research and development, allowing it to function as a private company with access to cutting-edge research facilities while keeping its costs low. Those costs are being covered by several investment firms including Inventages Venture Capital GmbH (life ventures by Nestle), Burrill & Company, Polar Investments Ltd and Biotech M.A.H. Plant Genomic Fund.

The company currently has 2 drugs in development. The first, which has already commenced its Phase III clicnical trial development, is a new, oral drug for treatment of auto-immune diseases. In its Phase II, double-blind clinical trial, PMI-001 was given to 120 patients with moderate to severe rheumatoid arthritis. The results showed significant efficacy of the drug, with rapid pain reduction in as little as 2 weeks and a halt in joint erosion in 6 months. PMI-002 is the second botanical drug under development and shows promise in the treatment of cancerous cells as well as the possible prevention of neurological and opthalamic degenerative disorders.

Other drugs are also in their pipeline, but have not yet received the same focus as their other products (it seems due to lack of funding). These products include:

• A botanical bioactive that acts as a COX-2 inhibitor but with less risk than a Vioxx, Celebrex or other synthetic chemical entity.
• A botanical appetite suppressant that could be leveraged for weight loss, and a counterpart derived from an agricultural waste processing stream that could block fat absorption.
• A plant-derived agent that could be used to limit the impact of aging on muscle cells.

It seems that these drugs, along with the proprietary methodologies the company is using to develop them, could usher in a new wave of drugs that will be prescribed by doctors in the future. As you may know if you’ve read a few of my posts, I’m very interested in keeping an excessive amount of “artifical” stuff out of my body, and the research here shows promise for drugs that may be headed in that direction. I am hopeful that companies like Wellgen and Phytomedics can provide breakthroughs in this area of research and demonstrate the safety and efficacy of these drugs because of their origins as completely natural substances.

However, until an actual product has been released and clinical trials can demonstrate the safety of the product and its interaction in the human body can be better understood, I remain cautious of drugs developed within this emerging field.

Your thoughts?

(1) See “What is a Botanical Drug?“, FDA web site.

One of the persistent challenges of the Pharmaceutical industry has been maintaining the safety and efficacy of drug products in patients over time. In other words, when a patient starts taking the drug, the patient is able to take a lower, safer dose of the product in order to treat the symptoms. However, over time, the patient becomes desensitized or builds tolerance to the drug such that he/she must take higher, less safe doses of the product in order get the desired effect. Eventually, the dosing may reach dangerous levels causing serious, or even fatal, side effects. The crux of the problem is that the pharmaceutical industry does not really have a handle on how target drug-receptors are activated or de-activated in the body in order to achieve the desired result. As a result, desensitization is viewed as an unavoidable side effect.

Last week, I attended the NYC Bio Meetup. One of the presenters was Richard G. Lanzara, President of Enhanced Pharmaceuticals (EP). EP is attempting to combat the problem described above by modulating targeted drug-receptor effects to create new drug combinations which are safer and more effective. EP’s methodology combines an agonist, which triggers a response from the receptor, with an antagonist, which produces no response from the receptor and can block the action of the agonist, in a calculated formulation in order to optimize the drug’s efficacy while curtailing desensitization. EP has shown promising research for improving products used to treat heart failure and asthma. Additionally, EP believes that drugs used to treat Parkinson’s disease, memory loss and other diseases can be enhanced to reduce patient tolerance.

EP does not yet have a website, but the technology was transferred from Bio Balance, and one can obtain more information about their philosophy and technology on the Bio Balance website. EP’s goal is to license the technology to pharmaceutical and biotech companies so that these companies can develop safer, more effective new products and enhance (and potentially extend the patent life of) their existing product lines.

In my limited research (within the first 10 pages of some Google searches), I did not find any competitors for EP nor did I find anyone refuting the ideas and technology put forth by EP/Bio Balance. However, it may be safe to assume that pharmaceutical companies, small and large, have put significant resources toward developing similar/competing technology. On the other hand, this type of technology brings the ethics vs. profit question into light for Big Pharma. While companies have an ethical duty to put forth the safest and most effective products, they may not be able to sell as much of their product if they do. If they are able to create a product that does what it is supposed to do for as long as the patient needs it without a build up of any kind of tolerance, then the patient will never need to increase dosage (such as taking two pills instead of one) and there will be less of a need for more costly variations/extensions of the same product (e.g. extra-strength” variations). Do pharmaceutical companies really want this technology? EP is betting that they do.

EP hopes to start Phase 1 clinical trials of their technology in the near future. Ideally, the clinical trial process will prove that the technology works and provide answers to some of the following questions:

• Over long periods of time, do the combination products retain their efficacy or does desensitization eventually occur? This question may or may not be answered in clinical trials depending on the amount of time it takes to build up tolerance.
• Will the formula work the same for everyone? Different people build up tolerance at different rates. A drug’s efficacy varies from person to person. Will EP’s formula work the same for everyone or will the ratio of agonist-to-antagonist need to change from person to person?
• What new side effects will appear with the agonist/antagonist combination products? While the adverse affects for agonist alone and antagonist alone may be well known, unexpected events may occur when taken together.

EP’s methodology is certainly something to watch in the coming years. If EP can demonstrate that their technology really works and drug companies buy into it, then consumers can look forward to drug products that get the job done safely every time.