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.

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.

First on the list is Advair, an asthma medication. He cites an analysis in 2006 of 19 trials that suggested that regular use of LABAs (long-acting beta-agonists) can increase the severity of an asthma attack, even to the point of death. Advair (also known by its generic name salmeterol), is the most popularly prescribed of the LABAs and could contribute to as many as 5,000 asthma-related deaths each year in the US. It lead to the FDA labeling the drug with a black-box warning, its most severe.

The next two on his list are probably familiar to readers of this blog: Avandia and Celebrex. I’ve written at length about the two, and their challenge to stay on the market in spite of being labeled with their own black-box warning by the FDA (search for “Avandia” or “Celebrex” and you’ll find multiple posts on this site). Avandia was removed from the market at one point because it was linked to cardiovascular disease in some patients. Celebrex, like its other CO2-inhibitor cousins Bextra and Vioxx, was also associated with cardiovascular risk.

The powerful antibiotic Ketek is next on his list, which is prescribed to fight bacteria in the lungs and sinuses, but has been liked to heart-rhythm problems, severe liver side effects and poor interaction with other medicines one may be taking. In February 2007, the FDA formally limited its use only in the treatment of pneumonia.

Heartburn medications Prilosec and Nexium were next, and again, there is an investigation that’s been done by the FDA into a suspected link between these medications and heart attacks. Based on that investigation, the FDA said there isn’t a likely connection, which Lord interprets as meaning “the scientific jury is still out,” but I would hardly put this on a list of “medicines to avoid” if no conclusive link has yet been made even after a study has been completed. He goes on to indicate that the medicines are perhaps too effective anyway, because that same sensation of burning in your chest will kill incoming bacteria and germs that could lead to pneumonia.

Visine was next, a surprise when I first read it until I realized he was talking about the original formula. The original formual “gets the red out” of your eyes by constricting the blood vessels causing the redness, and not actually addressing the cause (such as dryness or allergies). Continual use can perpetuate and even worsen the problem. When my eyes get dry, I occasionally use Visine Pure Tears, which do not contain the active ingredient tetrahydrozoline, which causes the constriction seen with use of Visine Original. (I was waiting for the link to heart attacks, but it never came for Visine.)

The final drug on the list was Pseudoephedrine, a decongestant that could cause problems for people with heart disease or hypertension because it not only constricts the blood vessels in your nose and sinuses, but could also raise blood pressure and heart rate, a definite problem if you have a history of heart problems.

For each drug, Lord does an excellent job of giving alternatives to these medications, but I felt like his profile for each of these was a bit alarmist in nature. Are these really 8 drugs that doctors would never take? So many of them seemed to be linked to heart problems, but do they actually cause heart problems or exacerbate existing conditions? What’s his basis for claiming that most doctors wouldn’t pick up the Physicians’ Desk Reference to check for the serious side effects that these drugs may cause? Or, for that matter, not warn their patients of the potentially fatal side effects and risk a serious malpractice suit?

I would have liked to see some kind of indication of a study (e.g., ‘x’ number of doctors were surveyed for this article and ‘y’ picked these 8 drugs as things they would never take) or some other insight as to why he picked these particular drugs. And what does he say to people who are already on these drugs and find they’re helping? In my post, “Heartburn Relief,” there’s evidence that the alternatives he suggests for Prilosec and Nexium aren’t as effective at treating heartburn. And drugs like Celebrex succeeds in spite of its black box warning because, simply, it works for it patient base who should be well aware of the dangers of their medications if their doctors are doing their job in disseminating information appropriately (I explored this more in “Succeeding in Spite of a Black Box“). Is it realistic to think that prescriptions for these medications are haphazardly given, or are the patients taking them better educated than we think?

I’d love to see more of Lord’s work into this area, perhaps a deeper profile into the doctors that *do* prescribe these medications (or suggest them, in the case of over-the-counter drugs) and why they do so. For that matter, I’d be more interested in taking a closer look at over-the-counter drugs that could be dangerous if taken in high doses, or problematic at least if they’re taken at the recommended doses. Claritin, for example, is a godsend for me during allergy season, but I’m always concerned when a drug makes a jump from prescription-only to over-the-counter. What about Zyrtec?

Lord’s article makes for interesting reading. But there is definitely more research that would need to be done before I would be convinced these are the 8 drugs doctors would not prescribe, and certainly a wealth of other information out there from which people would probably benefit. I hope he, or another writer, will explore the possibilities soon.

What do you think?

Later in that networking meeting, another colleague announced that it had recently been discovered that drinking water is contaminated with trace amounts of a number of both prescription and over-the-counter drugs. I had heard the same thing earlier in the week, but it wasn’t accompanied by the type of fanfare that I would have expected from such a discovery. While I was getting my car serviced this morning, then, I searched the internet for the article, and in fact found an AP probe into the drinking water supplies of at least 41 million Americans, including some of us in New Jersey (eek!).(1)

In fact, the amount of drugs found in the drinking supplies is minute, only measured in parts per billion or trillion, probably not enough to have any kind of immediate substantial effect. But the problem is the wide variety of drugs that do exist in the supply, from over-the-counter ibuprofen to antibiotics and mood stabilizers, and their long-term effect on human health.

The drugs are being delivered to our reservoirs and other water sources through our own waste. When a person takes a drug, only a certain percentage of that drug is absorbed by the body, and the remainder is flushed both out of a person’s system and subsequently down a toilet. Sewage treatment plants purify the water and discharge it back into reservoirs, streams and lakes. Some of that water is then cleansed again by drinking water treatment plants and piped to consumers, where the cycle begins anew. At no point in the current process is the water tested, or filtered, for residue drugs, and while this may not be a problem for a few years of exposure, scientists and researchers are concerned about the long-term health effects.

Here are some of the key results that the AP was able to ascertain:

• Officials in Philadelphia said testing there discovered 56 pharmaceuticals or byproducts in treated drinking water, including medicines for pain, infection, high cholesterol, asthma, epilepsy, mental illness and heart problems. Sixty-three pharmaceuticals or byproducts were found in the city’s watersheds.
• Anti-epileptic and anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.
• Researchers at the U.S. Geological Survey analyzed a Passaic Valley Water Commission drinking water treatment plant, which serves 850,000 people in Northern New Jersey, and found a metabolized angina medicine and the mood-stabilizing carbamazepine in drinking water.
• A sex hormone was detected in San Francisco’s drinking water.
• The drinking water for Washington, D.C., and surrounding areas tested positive for six pharmaceuticals.
• Three medications, including an antibiotic, were found in drinking water supplied to Tucson, Ariz.(2

Because extensive testing isn’t done by most of the plants that filter this water, the AP suspects that the situation may be worse than what has been discovered so far. Not so much in terms of amounts of these pharmaceuticals in the water, but in terms of their diversity. And because federal regulations do not require trace drug testing, all can claim they adhere to the rules set by the government.

The article provides an extensive analysis of the problem and indicates this is not something that is easily escaped. Bottled water, ground water, even water from other countries could be contaminated. The major contributors to the problem is humans, but as veterinary health increases its use of prescription medication for both pets and livestock, they are also generating waste that delivers trace amounts of their medication into the ground.

People like me are likely to be the most upset about this kind of development, because I’ve made an effort in my life to only use medications when absolutely necessary. I feel frustrated that the decision may not be mine to make, and as the problem worsens, both my children and the children of my friends will have a greater exposure than we ever had. And the fact that there is no realistic way to avoid exposure — neither bottled nor tap water are immune to this problem — makes me wonder who is responsible and to whom we should turn for answers.

Granted, I’ve been drinking the same water for years, and I haven’t had any ill effects. The truth is, nobody knows whether the drugs in our water are hurting or helping us.  But how could we have let things get so bad that now it’s something we can’t avoid?

How do you feel about it?

(1) See ” AP Probe Finds Drugs in Drinking Water,” By Jeff Donn, Martha Mendoza and Justin Pritchard, the Associated Press web site, March 9, 2008.

(2) See ” AP Probe Finds Drugs in Drinking Water,” By Jeff Donn, Martha Mendoza and Justin Pritchard, the Associated Press web site, March 9, 2008.

Obviously, not all clinical trial participants treat their participation as a job; some are people who are donating their body in the hope of finding a cure for some disease that afflicts them, while others are health but participate for extra cash. Many, however, are like Brandon, a 30-year-old professional lab rat that spends a good part of his free time in a research facility. In the last 18 months, he earned $25,000 in a number of trials in Michigan, Indiana and Texas, likely earning more than in his previous career path: a part-time, minimum-wage job hopper. As he puts it:

“This is the longest I’ve ever done anything,” says Brandon. “I don’t plan on doing it forever, but it sure beats the heck out of working at a regular job.” (1)

Brandon’s lifestyle may not be right for me, living study after study, subjecting my body to likely safe, but still experimental chemicals (only 1 in 10,000 will suffer a fatal side effect).(2) For now, though, it seems to work for him and guinea pigs do help determine what drugs are safe to bring to market.

Or do they?

The biggest problem with these volunteers is what they do for the money they earn for each study. In a Johns Hopkins survey, 10 percent of a sample group of research volunteers admitted to participating in more than one study at a time — double-dipping, so to speak — and most likely doing so without the knowledge the researchers. (3) In most other careers, this kind of multitasking would probably be applauded, but in clinical research it is risky behavior. Treatments for the different studies may interact in unpredictable ways, skewing test results, causing harm to the volunteer and subsequently blocking the drug’s path to approval.

Federal regulations exacerbate the problem because personal information that could identify study participants are supposed to be kept confidential. This wouldn’t be as much of a problem if there were only a select few research facilities where the drugs were being tested. But that coupled with the pharmaceutical industry’s increasing reliance on subcontracted, for-profit contract research organizations (CROs) makes tracking these moonlighting individuals difficult, if not impossible. As a result, the system is set up to almost encourage participation in multiple studies. Organizations that specialize in running clinical studies take advantage of this group of guinea pigs because the most time-consuming (and therefore costly) part of any clinical trial is finding those volunteers.

What does this mean for us? It means that as the prevalence of these professional clinical trial volunteers who participate in more than one study increases, so do the risks of results being skewed. These results, once reviewed by the FDA for approval, could prevent a critical drug from reaching the market because of its reaction with an entity about which the researchers weren’t aware. A worse scenario in my mind would be a drug prone to present a patient with more side-effects, but that was effectively neutralized by a drug that was being taken by a patient in another study. Forgoing the scientific process for the sake of earning a few extra dollars could put more people at risk down the line than just these professional volunteers.

To guard yourself against any kind of adverse event that slipped through a clinical trial, follow these four steps outlined by the Jenna Stumpf as a sidebar to “Drug-Test Dummies:”

Don’t be first

Unless there’s no comparable durg available, try to stick with a medication that’s been on the market for 2 years or longer. Like a new car model, a brand-new drug may still have bugs that weren’t worked out (or even detected) in clinical trials, says Steven Scott, Pharm. D., an associate professor of clinical pharmacy at Purdue University.

Stay at One Store

If a doctor hands you a prescription and you forget to mention that you’re on other medications, you risk a drug interaction. That’s why Robert Freeman, Ph.D., a professor of pharmaceutical sciences at Texas A&M, recommends that you fill all your scripts with the same pharmacist- and run any over-the-counter drugs or supplements by him too.

Use a Safety Net

Add extra insurance against an interaction with a free account at epocrates.com. This database acts as a virtual pharmacist, cross-referencing your meds to see if any don’t play well together. Used by more than 500,000 health-care professionals, Epocrates alos provides a layman’s summary of the indecipherable drug-info pamphlet.

Watch Yourself

Before you start a new medication, take stock of how you feel. While upset stomach, headache and drowsiness are all relatively common reactions, they should pass as your body adjusts to the drug, says Freeman. If they persist for longer than 3 days or you feel any muscle or abdominal pain, see your doctor.(4)

While it may be clear there is a problem with the system, even the strongest critics agree that it is necessary to ensure the safety of drugs brought to market. However, until new safeguards are implemented to prevent people like Brandon from taking advantage of the flaws, there is always a chance there will be skewed results dictating the fate of that new drug. That is a shame, because though I know I am conservative about taking medications, I do believe many drugs provide a benefit that cannot be measured by those people who depend on them. In a scientifically tainted clinical trial, they are the ones who stand to lose the most.

(1) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128.

(2) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128, sidebar: the high cost of clinical trials.

(3) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128.

(4) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p130, sidebar: Prescription Protection by Jenna Stumpf.

Installing More Flashing Red Lights

In “FDA Turns Attention to Detection,” Jill Wechsler concentrates on upcoming changes to the FDA’s Adverse Event Reporting System (AERS). AERS is the FDA’s current surveillance method for drugs currently available to the public, tracking some 4 million case reports and growing by about 300,000 submissions per year. While the information is extensive, its quality varies and has been identified as a major shortcoming in the current iteration of the system. (1)

Regardless of the quality of data, however, the FDA defends AERS’ use because it covers all FDA-regulated products and subsequently reaches a large portion of patients, including any that might be using a drug for an off-label purpose. It is considered especially effective at highlighting rare, unexpected drug safety problems, a sentiment echoed by a majority of healthcare professionals and cited as a reason that the system should be strengthened and augmented by other safety systems, not replaced.

To Imply or Not To Imply

While the FDA works on safety, Congress is staging an investigation into the celebrity endorsements that are accompanying more and more direct-to-consumer (DTC) ads on TV. In “Attack Mounts on DTC Ads,” Jill Wechsler outlines a new effort by Michigan Democrats John Dingell and Bart Stupack to challenge Pfizer’s use of celebrity spokesman Dr. Robert Jarvik, a prominent contributor to the invention of the artificial heart, in commercials for Lipitor (atorvastatin), the blockbuster anti-cholesterol drug. I recall the commercial vividly, its impact perhaps resting in the subconscious part of my brain, and I remember assuming that Jarvik was giving his testimony based on the background of a heart specialist.(2)

Contrary to my belief, Jarvik is not a heart specialist and it’s probably inappropriate to imply as such; it is because of this misleading advertising to consumers that Dingell and Stupack have chosen to investigate. Also on their list for investigation is Vytorin commercials, a joint venture by Merck and Schering-Plough. The Congressmen have been provided documentation by the FDA, and the investigation is currently ongoing.

Rx Email: Redux

In Europe, the United Kingdom is attempting to halt false advertising from another source: illegitimate online pharmacies. According to “UK Tackles Faux Pharmacies Online” by Sarah Houlton, the Royal Pharmaceutical Society of Great Britain (RPSGB) has launched a new logo that will help certify an online pharmacy is a legitimate source of medication for consumers. You may recall I examined the ever-expanding problem of online pharmacies in “Rx Email,” and indicated that the increasing prevalence of this problem necessitates action by agencies around the world; with an estimated 2 million people now use the internet to buy their medications in the UK, it is becoming obvious that the issue likely needs to be dealt with now.

Registered participants in this program will receive a new logo and registration number to be used on their home page. The logo will be a link leading to a list of legitimate sources for online drugs as maintained by the RPSGB. Almost 50 online pharmacies now participate, and the hope is that the system will discourage the dishonest traders. (3)

The magazine, as usual, gave me plenty of material to think about. Does the FDA AERS need to be augmented? Or should the original system be re-examined and re-built to encourage a more efficient and effective process? Should drug companies be allowed to use celebrity endorsements and imply claims that they cannot make? Or is this type of marketing no different than the marketing of a car (buy our car and you will be cool) or some other product? Where do the differences lie? Could the method being developed by the RPSGB really discourage the sales of illegitimate drugs online, or is it simply another roadblock for these bogus sources to overcome?

Regardless of the answers to these and other questions that may arise in my mind as I continue to read, it appears there is increasing effort by governmental organizations to keep their consumers safe from spurious, possibly false and sometimes illegal dissemination of information. No agency is perfect, but it is encouraging to know there are people within them who are doing their best to make me a little safer as a consumer.

What do you think?

(1) See “FDA Turns Attention to Detection,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 14.

(2) See “Attack Mounts on DTC Ads,” Jill Wechsler, Pharmaceutical Executive Magazine, March 2008, p. 18.

(3) See “UK Tackles Faux Pharmacies Online,” Sarah Houlton, Pharmaceutical Executive Magazine, March 2008, p. 18.