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At long last, marijuana for medical use is legal in New Jersey. As one of his more courageous acts while in office, outgoing Governor John Corzine signed the act into law late yesterday making New Jersey the fourteenth state to legalize medical pot. Four more states and the District of Columbia are expected to follow suit by year's end.

Many things are driving this sea change. The federal government last year announced that it would no longer prosecute medical marijuana smokers in states where it is legal, while the National Institutes of Health has begun funding research on medicinal use in a reversal of a long-standing policy.

Gallup Polls show a solid majority of Americans sympathetic to therapeutic marijuana use.

Unlike California's medical marijuana law which allows the use, possession, and cultivation of marijuana by anyone who possess a "written or oral recommendation" from their physician that he or she "would benefit from medical marijuana," New Jersey's version requires patient identification cards and state-monitored dispensaries -- easing fears that medical use will fuel illegal sales and teenage substance abuse.

While cannabis preparations have been used to relieve nausea and pain since ancient times, research involving medical uses of marijuana was under funded and in many instances discouraged according to an article in today’s New York Times. But over the last 15 years, research on the body's cannabinoid receptors has begun to decipher the chemistry and biology of the positive effects of cannabinoids especially in the areas of glaucoma and chemotherapy induced nausea and vomiting experienced by patients being treated for cancer. More recently, clinical trials have shown that these benefits outweigh the concerns about addiction, heart and respiratory diseases, cancers, and psychoses -- at least, with short-term use.

Marinol, a synthetic cannabinoid pill, is approved by the Food and Drug Administration for treating AIDS-related wasting and chemotherapy-related nausea. But many patients say choking down a slow-acting pill simply doesn't provide the convenient and immediate relief of inhaling marijuana smoke. A new drug, Sativex, made by GW Pharmaceuticals, may renew the debate. A cannabinoid-based oral spray, Sativex is approved in Canada for treating pain in multiple sclerosis and advanced cancer. The company is now completing the clinical testing needed for approval in Europe and the United States.

While I don’t endorse or use illegal drugs (any more), there is no question that medical marijuana helps patients deal with chronic and, in some instances, severely debilitating conditions that impact the overall quality of their lives. I have long contended that just because a substance is deemed illegal it doesn’t negate potential medically-beneficial properties. An example of legal drugs that don’t have any therapeutic benefits and cause much more morbidity and mortality than marijuana are cigarettes and alcohol. Need I say more?

All I gotta say is that we have come a long way since I saw the film Refer Madness while growing up and coming of age in the late 60s. For those of you who haven’t seen the film it is funny whether you are straight or high! object width="445" height="364">

I guess the nation—well NJ anyway—is finally going to pot!

Until next time...

Good Luck and Good Toking (only for medicinal purposes of course)!!!!!!!!!!!

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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry! 

Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.

While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.   

The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.

In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time...

Good Luck and Good Job Hunting!!!!

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We were able to entice Berci Mesko —a Hungarian medical student who writes at ScienceRoll and is founder of Webicina —to chat with us about the transection of Web 2.0, science and medicine.

Berci, who only sleeps four hours each night, is a medical section editor at Wikipedia, runs courses in Second Life (and real life at his medical school) and can frequently be found on Twitter enlightening his followers on topics ranging from personalized RSS feeds for physicians to the latest breakthroughs in medical genetics. While this ought to be enough for most people, Berci told us that he always wanted to be a scientist and— to realize this dream— will be entering a PhD program next fall. He is a very bright, energetic and engaging fellow whose understanding of the relationships between physicians and patients are insightful and instructive.

Have a listen and also check out BioCrowd!

Until next time…

Good Luck and Good Listening!!!

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