Medical Marijuana Use Is Legal in New Jersey

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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Chemotherapy Induced Nausea and Vomiting and Medical Marijuana

For the past month or so I have been working on a piece about chemotherapy induced nausea and vomiting (CINV) that is common among patients being treated for cancer. While not a pleasant topic, it is a reality for many patients who undergo cancer chemotherapy treatment.  Although CINV is less common with some of the newly-developed anti-cancer monoclonal antibody treatments, it is still a troublesome and debilitating problem that must be managed during conventional cancer chemotherapy treatment regimens. 

There is a growing body of evidence that marijuana (delta-9-tetrahydrocannabinol is the active ingredient) and related cannabinoid-like agents may help to effectively manage and control CINV in certain patients who are undergoing cancer chemotherapy. Recognizing this, 14 states have already legalized marijuana for medicinal purposes. Interestingly, according to Newsweek Magazine (November 2, 2009), the US government could save as much as $13.5 billion annually if it stopped enforcing laws against marijuana. To that end, the Justice Department says it will no longer prosecute people who use if for medicinal purposes in the 14 states where that's legal.

While I am not advocating illegal drug use, it seems silly to me that the inherent, medically-beneficial properties of  marijuana haven't been fully utilized to treat patients who are suffering from potentially life-threatening illnesses like cancer.  Further, there are legal and medical precedents for the use of illegal drugs that offer medical benefits. For example, while opium use is illegal in the US but morphine and related products (which are derived from opium and poppy plants) are legal prescription drugs that are regularly used to control acute and chronic pain in millions of Americans. Unfortunately, research on development of cannabinoid-like drugs to treat CINV has been stifled because of the illegality of marijuana.

The number of patients being treated for cancer rises each year. Isn't it time to start offering patients the best and most effective medical treatments available to them rather than continuing to adhere to out dated and unevenly enforced US drug laws?

Until next time...

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

 

BMS To Buy Kosan Biosciences

Bristol-Myers Squibb announced today that it will purchase California-based Kosan Biosciences for approximately $190 million. Kosan has been developing two classes of oncology drugs known as heat shock protein 90 (Hsp90) and epothilones. One of Kosan's Hsp90 compounds is currently in Phase III clinical testing for the treatment of multiple myeloma.

Kosan’s epothilone program will complement existing BMS programs designed to develop novel chemotherapy-based oncology products. The Hsp90 clinical program will help to sure up BMS’s push to become a next generation biopharma company.

Kosan was originally founded as an antimicrobial drug development company based on a novel combinatorial drug development (polyketide) platform but eventually morphed into a cancer-focused business. In addition to Kosan’s pipeline, BMS will inherit a small GMP biomanufacturing facility.

The acquisition is good news for Kosan which has been struggling of late. Unlike most other companies, BMS usually retains the employees of companies that it acquires. That said, only time will tell.

Until next time…

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

FDA Advisory Panel Gives a "Thumbs Up" To Continue Using EPO for Cancer Patients

According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

Until next time….

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

The EPO Saga: The Demise of a Blockbuster Drug

Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

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