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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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Pfizer was the first to bring us ED (erectile dysfunction) and now two companies—one large (Johnson and Johnson) and one small (Sciele Pharma)—are daring to boldly go where no MAN has gone before: to conquer PE aka premature ejaculation!

According to a brilliantly-crafted story by Natasha Singer published in this Sunday’s New York Times business section, JnJ developed a pill called Priligy which is intended for men who ejaculate before intercourse or within a few seconds after beginning. Priligy which is intended to help to prolong latency before orgasm is approved and sold in nine countries but hasn’t been approved for sale in the US. On the other hand (so to speak), little known, Atlanta, GA-based Sciele Pharma is planning to seek regulatory approval for a prescription aerosol-based product that is sprayed on the skin (in this case the penis) to prolong latency and forestall ejaculation. While the true incidence of PE is uncertain, the manufacturers of these medications want men (and women) to believe that the condition is more pervasive and prevalent than reported. 

Interestingly, the worldwide sales of Pfizer’s Viagra were approximately $1.93 billion last year. As previously noted on BioJobBlog, Viagra celebrated its 10th anniversary of marketing approval last March. If you do the math, almost $20 billion dollars worth of Viagra prescriptions were written over the past decade. This suggests that many millions of men must suffer from ED worldwide. However, for those of you who may not know, Viagra also works quite well for healthy, sexually active males who don’t suffer from ED. It is generally acknowledged that it is this segment of the male population that is responsible for the annual blockbuster sales of Viagra and related medications. Also, it is important to note that prior to the introduction of Viagra, ED wasn’t a recognized clinical indication (it was known as impotence) and there were very effective treatments for it. And while ED is a legitimate quality-of-life issue, it occurs in only a small percentage of sexually active males; mostly in older men with hypertension, cardiovascular conditions or those who have had their prostates removed.

Viagra, like Botox, Latisse and others, is classified as a so-called “lifestyle” drugs. Generally speaking, lifestyle drugs are developed to improve the quality of life of patients not treat potentially life threatening diseases or conditions. In her article, Ms. Singer takes the pharmaceutical industry to task about the development of  blockbuster lifestyle drugs.

“But creating a blockbuster quality-of-life drug like Viagra involves more than just being innovative or being first. Sometimes it requires a drug maker to create and market a whole new category of disease.

The template goes something like this: Start with a legitimate quality-of-life issue — like fitful sleep or shyness — that does not yet have its own prescription medication and is debilitating to a few people a lot of the time. Next, position the quality-of-life issue as a medical condition with symptoms so common it covers vast numbers of people who had previously not identified themselves as having a health problem, or who thought they were just experiencing an occasional and normal annoyance.

Articles in medical journals with high estimates on the prevalence of the issue help convince doctors and journalists of its scope. F.D.A. approval of the new drug legitimizes the condition as a problem with a medical solution.

While there is no doubt that some men are distressed about their inability to control their orgasms, there is little concrete evidence to suggest that there is an epidemic of premature ejaculation”

Although I have never used Viagra, I have a few “older male friends” who swear by it! And, while I have no doubt that Viagra and the new medications being developed to treat PE may benefit a few men, is it appropriate to elevate premature ejaculation to a bona fide clinical indication and spend billions to develop and market treatments for it? Don’t get me wrong; I am not trying to minimize the emotional distress and discomfort associated with PE. But, the last time I checked, PE didn’t make the top ten lists of the world’s most devastating and debilitating clinical indications or unmet medical needs!

Until next time...

Good Luck and Good Job Hunting!!!!

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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!!!!!!!

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According to a recent report issued by the Pharmaceutical Manufacturers of America (PhRMA), a record 861 new cancer treatments are being developed by pharmaceutical and biotechnology companies. Many of these treatments, which include vaccines and immunomodulators, are in clinical development or awaiting regulatory approval.

The breakdown of the treatments based on therapeutic areas is: 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer and 103 for prostate cancer. Additional treatments target brain, kidney, pancreatic and other forms of cancer.

While there are many other unmet medical needs that must be addressed by the life sciences industry, the burgeoning and ever-increasing numbers of cancer patients suggests that there is a dire need for development of improved anti-cancer treatments. To that end, if you are contemplating graduate school, already enrolled or trying to determine what therapeutic area makes sense for a postdoctoral fellowship, I highly recommend that you consider oncology. Job opportunities in this field (and neuroscience) will continue to outstrip all others in the near future.

Until next time...

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

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Bristol-Myers Squibb (BMS) announced late yesterday that it intends to purchase Princeton, NJ-based Medarex for $2.1 billion. BMS and Medarex were working collaboratively to develop a monoclonal antibody called Ipilimumab as a treatment for late stage melanoma.

The acquisition represents BMS’s public commitment to transform itself into a “next generation pharmaceutical company” with both pharmaceutical and biotechnology products in its arsenal. Last year, BMS bought Kosan Biosciences, Inc a California-based biotechnology company developing novel cancer treatments. Also, as you may recall, BMS lost ImClone to Lilly in a bidding war over Erbitux—a monoclonal antibody-based colorectal cancer treatment that was co-marketed by BMS. 

Medarex was one of the last independent, public, late stage monoclonal antibody development companies in the biotechnology industry. Many of its competitors, like ImClone and Cambridge Antibody Technologies, had already been acquired by big pharma and I was wondering when Medarex would be acquired. I have always held Medarex in high regard and it is a solid and well position company. To that end, I recommended that my mother purchase Medarex stock several years ago telling her that I thought it had a huge upside. Not surprisingly, the stock has been soaring since the announcement; so much so that my mother called me today to tell me how smart I was—go figure.

It is not clear, at present, what effect, if any, the Medarex acquisition will have on the employment situation in New Jersey. Although BMS is headquartered in NYC, it has two large sites in New Jersey, one in Lawrenceville and the other in Plainsboro. As mentioned above Medarex is based in Princeton, NJ. BMS has been steadily downsizing over the past three years and I suspect that there may be more layoffs after the Medarex deal closes.  If there are layoffs, more are likely to occur on the Medarex side of the business.

While I have been critical of some of BMS’ strategic moves in the past, I think the Medarex acquisition is an outstanding one and BMS will likely benefit from it!

Until next time...

Good Luck and Good Job Hunting!!!

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Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.

As you may recall, Merck was acutely aware of the terms of marketing agreement before it decided to purchase SGP and cleverly engineered the acquisition as a reverse merger— to prevent triggering provisions that could return Schering’s marketing rights for Remicade and Simponi to JNJ if their were leadership changes or a change of control at SGP. JNJ’s announcement contesting wasn’t unexpected after the Merck-Schering Plough deal was announced early last winter—sales of Remicade outside of the US topped $2.0 billion in last year. Simponi, Remicade’s highly touted successor (which recently received FDA approval), is also expected to reach blockbuster status after it reaches the market. 

The Merck-Schering deal left JNJ with few alternative or choices. The company could have counter offered to purchase SGP in its entirety or simply, as it did, invoke terms of the original agreement that would terminate SGP’s marketing rights if there was a “change of control” at the company. JNJ rightfully believes that a change of control will occur when Merck acquires SGP. According to a JNJ spokesperson “As its public statements make clear Merck is acquiring Schering Plough. The acquisition constitutes a change of control and trigger’s Centocor’s right to terminate.” It will be interesting to see how an arbitrator rules in the case.

While the loss of Remicade and Simponi isn’t likely to jeopardize the Merck-Schering Plough deal (according to Merck executives), it may affect the financial terms and overall benefit or upside of the acquisition. The expected completion of the deal is scheduled for the fourth quarter of this year.

Until next time...

Good Luck and Good Job Hunting!!!!

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The New York Times reported today that Genentech’s blockbuster cancer treatment, Avastin, failed to show a significant effect on preventing the recurrence of colon cancer, limiting its utility as an adjunct treatment to treat primary colorectal cancer. While Avastin is already a best-selling cancer treatment, success in this closely watched and highly visible clinical trial could have paved the way to a new uses of the drug, potentially increasing sales by billions of dollars a year.

Avastin had sales of $2.7 billion in the United States alone last year. But it is currently approved only for late-stage colon, breast and lung cancers. For those indications, patient’s lives have been prolonged for up to a few months. The new trial was designed to determine whether or not Avastin could be used earlier in the course of the disease, right after surgery to remove the tumor. The hope of such so-called adjuvant therapy is to prevent the cancer from coming back at all, effectively curing the patient.

While the Avastin failure will have little or no effect on Genentech’s financial outlook, it does call into question whether or not Roche paid too much last month to buy the 44 percent of Genentech it did not already own. Roche has long insisted that its desire to own all of Genentech did not hinge on the results of this trial. And yet, the trial appeared to play a major role in Roche’s months-long negotiations with Genentech.  It appeared that Roche, which had started those discussions last summer, wanted to complete the deal before results of the Avastin trial were announced — on the assumption that a successful trial would have sent Genentech’s stock soaring, possibly putting the takeover price it offered out of reach.  A failed trial, on the other hand, could have pushed down the value of Genentech’s stock. So it now looks as if Roche could have paid less had the results of the Avastin trial come out before it completed the deal.

Art Levinson, Genentech’s former CEO who played hardball with Roche over the course of negotiations, needs to be recognized for his outstanding business acumen. He and other Genentech executives convinced Roche that Avastin sales could quadruple, to $10 billion, by 2015 if the drug could be used for early-stage colon, lung and breast cancers. This possibility induced Roche to raise its bid for Genentech’s outstanding shares from $86.50 to $95 per share. Although Dr. Levinson wasn’t able to fend off Roche’s takeover and is no longer Genetech's CEO, he is likely “laughing all the way to the bank” as the expression goes. And, who said that PhDs aren’t any good at business?

Roche shares were down more than 10 percent on Wednesday, closing at $29.54.

Until next time...

Good Luck and Good Job Hunting!!!!!

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It has been a long standing practice of mine to avoid co-mingling science and religious issues in any of the materials that I post online. I have refrained from doing this because I believe that enough tension already exists between religious advocates and scientists.   However, I was unable to control myself today after my wife pointed out two interesting articles in Wednesday’s New York Times.

The first article dealt with Pope Benedict XVI’s views on condom use and HIV transmission in Africa. Yesterday in Cameroon, he publicly said, for the first time, that condoms are not the answer to Africa’s fight against AIDS. Not only did this statement send a collective shiver down the spines of many HIV health workers, clergy working with AIDS patients are divided on the issue. The pope told reporters that “You can’t resolve it with the distribution of condoms. On the contrary, it increases the problem.” Apparently, church dogma suggests that fidelity in marriage and abstinence from premarital sex are crucial weapons in the fight against AIDS. There are currently 22 million people in sub-Saharan Africa infected with HIV and three-quarters of all HIV/AIDS deaths occur in the region. Apparently, attempting to be faithful and just saying no doesn’t seem to work in Africa—or anywhere else! The pope’s statement prompted a representative from the Treatment Action Campaign in South Africa to say “Instead, his opposition to condoms conveys that religious dogma is more important to him than the lives of Africans.” Ironically, Africa is the fastest-growing region for the Roman Catholic Church.

The second article reported the results of a study which showed that terminally ill cancer patients who drew comfort from religion were almost three-times as likely to seek aggressive, life-prolonging treatments as compared with less religious patents. Also, the most religious patients were much more likely to ask doctors to do ‘everything possible to keep them alive.’  Study results showed that patients who were devout were three times as likely as less religious patients to be put on a mechanical ventilator to maintain breathing during the last week of life, and they were less likely to do any advance care planning, like signing a do-not-resuscitate order or preparing a living will. The findings prompted one of the study’s authors—it will appear in Wednesday’s Journal of the American Medical Association (JAMA)—to say “People think that spiritual patients are more likely to say their lives are in God’s hands — ’Let what happens happen’ — but in fact we know they want more aggressive care.” To explain this apparent paradox, the author speculated “To religious people, life is sacred and sanctified and there’s a sense they feel it’s their duty and obligation to stay alive as long as possible.” Alternately, in my opinion it may be that religious people haven’t adequately dealt with the possibility of their demise and are hoping for miracles—medical or religious— to keep them alive because they are deathly (pun intended) afraid of dying? Regardless, aggressive life-prolonging care is expensive, Medicare spends about one-third of its budget on people who are in their last year of life and much of that is spent on patients at the very end of their lives. Moreover, researchers have found that aggressive end-of-live care for terminal patients frequently can lead to a more painful process of dying and greater shock and grief for family members.

One of the few places in the world where the nexus of religion and science is difficult to fathom is the US—one of the most scientifically advanced and religious nations in the world. Several years ago, I met a scientist at a FASBEB Career meeting who, for the first time, was able to successfully articulate to me how science and religion can co-exist in American society (she taught in the South). While I can’t recall her exact words, she said something like “Both science and religion have their purpose and place in society. However, they are belief systems that are not interchangeable. That is why I can believe in God and still fully endorse and embrace evolution. They serve different purposes for me and help me to live my life.” With this in mind, I don’t think that religious dogma should be invoked when it comes to treating patients or inhibiting advances in public health, science and medicine.

Until next time...

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

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The sequence of all known rhinovirus genomes reported in Science last week is an important advance for the field. Analyses of the sequences have revealed new relationships among the viruses, evidence for recombination, a new viral species, and conserved regions of the genome. These findings will be extremely valuable for those studying the biology, pathogenesis, and epidemiology of the common cold. But the press has over reacted to this work -  it was reported on the front page of the New York Times with the headline “Cure for the Common Cold? Not Yet, but Possible“.  Does the work deserve such fanfare?

The Times quoted Stephen Liggett, an asthma expert, as saying “We are now quite certain that we see the Achilles’ heel, and that a very effective treatment for the common cold is at hand.” He was apparently referring to the observation that a sequence within the 5′-noncoding region of the viral genome is highly conserved among the 99 rhinovirus sequences, in comparison with other regions of the viral RNA. He suggested that all 99 rhinovirus serotypes would therefore be susceptible to the same drug. But what kind of drug, and what function would it inhibit? The very 5′-end of the genome of enteroviruses and rhinoviruses binds viral and cellular proteins, and these interactions are essential for viral replication. So it might be possible to identify small molecules that block these protein-RNA interactions. But such drugs are very difficult to identify. Furthermore, if such a drug were identified, its efficacy would have to be tested against all rhinovirus serotypes. Therefore it is not clear that knowing that this sequence of the genome is conserved helps to identify drug targets and more readily than did the observations made years ago about the importance of RNA-protein interactions in this region. Clearly, many years of research are needed before such drugs are developed - not consistent with Dr. Liggett’s a treatment is ‘at hand’.

An even more crucial aspect of the problem was omitted from the Times article. Even if an antiviral drug could be identified that blocks essential RNA-protein interactions, it probably would not be useful in treating the common cold. As we discussed last week, rhinoviruses cause acute infections - characterized by rapid onset of disease, a relatively brief period of symptoms, and resolution within days. Most are complete by the time the patient feels ill, and the virus has already spread to another host. Antiviral therapy  must be given early in infection to be effective. There is little hope of treating most acute viral infections with antiviral drugs until rapid diagnostic tests are become available.

To be fair, some of the scientists quoted in the Times article were more realistic about the possibilities for rhinovirus treatments. One antiviral drug expert noted that it costs about $700 million to bring a drug to market. Because most rhinovirus infections are benign, who would pay for such an expensive drug, and would the Food and Drug Administration ever approve it? Ann Palmenberg, the lead author on the study, was even more realistic, admitting that a rhinovirus vaccine would not likely be made.

I cannot see how this new study identified a new or better target for therapeutic intervention. So why get the public excited by running a front page headline in the New York Times? It’s great to keep the public informed about scientific progress - but the press should not cry wolf. If this advance does not soon lead to a treatment for the common cold, the public will shake their heads and lose a bit more trust in science.

I’m not blaming the scientists for this over reaction to their study. I am sure that the journal Science engaged in strong pre-publication promotion: more publicity is better for their advertising revenues. And the newspapers are equally at fault: they should speak to a broader range of scientists to obtain a more balanced view. I particularly blame the author of the Times article, Nicholas Wade, for not sufficiently researching his article.

Perhaps Dr. Liggett and his colleagues would benefit from the lessons of history - specifically, the history of poliomyelitis and its conquest. On March 9, 1911, three years after the isolation of poliovirus, The Rockefeller Institute issued a press release, saying that it believed “that its search for a cure for infantile paralysis is about to be rewarded. Within six months, according to Dr. Simon Flexner, definite announcement of a specific remedy may be expected.” They quoted Dr. Flexner:  “We have already discovered how to prevent the disease, and the achievement of a cure, I may conservatively say, is not now far distant.” Dr. Flexner’s imminent ‘cure’ was a failure, and a successful poliovirus vaccine required another 44 years of research. Last week’s Times article seemed to have a similar overdose of hubris.

A. C. Palmenberg, D. Spiro, R. Kuzmickas, S. Wang, A. Djikeng, J. A. Rathe, C. M. Fraser-Liggett, S. B. Liggett (2009). Sequencing and Analyses of All Known Human Rhinovirus Genomes Reveals Structure and Evolution Science DOI: 10.1126/science.1165557

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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