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Drug & Device News

By ALM Staff | Law Journal Newsletters |
January 28, 2010

New Jersey Legislators Approve Medical Marijuana Bill

New Jersey's legislatures passed a medical marijuana bill on Jan. 11. It has been signed into law, making New Jersey the 14th state in the union to permit the use of marijuana for medicinal purposes. In a release by the New Jersey Senate Democrats announcing the bill's passage, one of the bill's co-sponsors, Sen. Nicholas P. Scutari, says, “New Jersey has a demonstrated record of being tough on illegal drug use and the underground drug trade. However, when it comes to medical marijuana, we're not talking about hardened criminals, but individuals looking for some small bit of relief from chronic pain and debilitating illness. New Jersey has no interest in treating these folks like drug kingpins, and should provide legal access to medical marijuana for New Jerseyans who need it.” The New Jersey Compassionate Use Medical Marijuana Act provides for patients with State-issued ID cards to obtain marijuana from special dispensaries when their physicians prescribe it. These individuals are not permitted to grow their own supplies, and they may only use two ounces of the drug per month. Rules for opening, registering and operating treatment centers are also included in the law. Patients are eligible for the ID cards if they have one or more of the legislation's enumerated “debilitating conditions,” such as glaucoma or cancer. Specifically not included in the law were more nebulous medical complaints, like anxiety, which are so broad that they have led to abuses in other states that permit the use of medical marijuana.

Drug Company Seeks Gag on Critic from UK Courts

Great Britain's libel laws are threatening to limit the discussion of drugs and their risks among scientists, doctors and patients. The issue made the news when General Electric, parent of GE Healthcare, filed a lawsuit in London seeking to silence Danish scientist Henrik Thomsen. The company says he publicly criticized the company's drug Omniscan in a professional publication and at a 2007 conference in Oxford, England. There is no dispute that Thomsen said that the use of the contrast agent Omniscan, which helps render MRI scans more readable, adversely affected patients with impaired kidney function at the Copenhagen hospital at which he practiced. He and other doctors there noticed that these patients, after having MRIs in which Omniscan was used, were contracting nephrogenic systemic fibrosis (NSF), a condition involving swelling, thickening and tightening of the skin. One of these patients died, and others are now confined to wheelchairs. However, General Electric's complaint says that in addition to making these observations, Thomsen wrongly accused it of knowing that the drug was dangerous, yet concealing this fact from doctors and the public. London's Sunday Times notes that its reporters were unable to get an answer from GE Healthcare's spokeswoman when asking her to identify particular libelous statements Thomsen made against the company. Thomas and Gerth, The Sunday Times, 12/20/09 (http://business.timesonline.co.uk/tol/business/law/article6962865.ece). Perhaps the complaint can explain the dearth of specifics: It claims that Thomsen's defamation of the company may have been “by way of innuendo.”

University Policy Change Promotes CME Integrity

Stanford University in January announced a new approach to continuing medical education (CME) under which it will accept funding from pharmaceutical companies, but with the condition that these companies will no longer be permitted to dictate or influence the topics to be taught. Drug manufacturer Pfizer Inc. has already pledged $3 million to fund CME under the new conditions, with the money to be spent over a three-year period. In a release announcing the change in policy, Phillip Pizzo, M.D., dean of Stanford's medical school, explained, “We continue to believe that robust relations between academia and industry are essential to translating knowledge from research to patients. And we believe that academia and industry have much to learn and teach each other. But the learning and teaching has to be free of marketing or influence and focused on truly improving the lives of the patients we serve and the students and physicians we educate. We are now entering a new relationship and I am encouraged that this can be a new beginning ' and a novel rebooting.”

New Jersey Legislators Approve Medical Marijuana Bill

New Jersey's legislatures passed a medical marijuana bill on Jan. 11. It has been signed into law, making New Jersey the 14th state in the union to permit the use of marijuana for medicinal purposes. In a release by the New Jersey Senate Democrats announcing the bill's passage, one of the bill's co-sponsors, Sen. Nicholas P. Scutari, says, “New Jersey has a demonstrated record of being tough on illegal drug use and the underground drug trade. However, when it comes to medical marijuana, we're not talking about hardened criminals, but individuals looking for some small bit of relief from chronic pain and debilitating illness. New Jersey has no interest in treating these folks like drug kingpins, and should provide legal access to medical marijuana for New Jerseyans who need it.” The New Jersey Compassionate Use Medical Marijuana Act provides for patients with State-issued ID cards to obtain marijuana from special dispensaries when their physicians prescribe it. These individuals are not permitted to grow their own supplies, and they may only use two ounces of the drug per month. Rules for opening, registering and operating treatment centers are also included in the law. Patients are eligible for the ID cards if they have one or more of the legislation's enumerated “debilitating conditions,” such as glaucoma or cancer. Specifically not included in the law were more nebulous medical complaints, like anxiety, which are so broad that they have led to abuses in other states that permit the use of medical marijuana.

Drug Company Seeks Gag on Critic from UK Courts

Great Britain's libel laws are threatening to limit the discussion of drugs and their risks among scientists, doctors and patients. The issue made the news when General Electric, parent of GE Healthcare, filed a lawsuit in London seeking to silence Danish scientist Henrik Thomsen. The company says he publicly criticized the company's drug Omniscan in a professional publication and at a 2007 conference in Oxford, England. There is no dispute that Thomsen said that the use of the contrast agent Omniscan, which helps render MRI scans more readable, adversely affected patients with impaired kidney function at the Copenhagen hospital at which he practiced. He and other doctors there noticed that these patients, after having MRIs in which Omniscan was used, were contracting nephrogenic systemic fibrosis (NSF), a condition involving swelling, thickening and tightening of the skin. One of these patients died, and others are now confined to wheelchairs. However, General Electric's complaint says that in addition to making these observations, Thomsen wrongly accused it of knowing that the drug was dangerous, yet concealing this fact from doctors and the public. London's Sunday Times notes that its reporters were unable to get an answer from GE Healthcare's spokeswoman when asking her to identify particular libelous statements Thomsen made against the company. Thomas and Gerth, The Sunday Times, 12/20/09 (http://business.timesonline.co.uk/tol/business/law/article6962865.ece). Perhaps the complaint can explain the dearth of specifics: It claims that Thomsen's defamation of the company may have been “by way of innuendo.”

University Policy Change Promotes CME Integrity

Stanford University in January announced a new approach to continuing medical education (CME) under which it will accept funding from pharmaceutical companies, but with the condition that these companies will no longer be permitted to dictate or influence the topics to be taught. Drug manufacturer Pfizer Inc. has already pledged $3 million to fund CME under the new conditions, with the money to be spent over a three-year period. In a release announcing the change in policy, Phillip Pizzo, M.D., dean of Stanford's medical school, explained, “We continue to believe that robust relations between academia and industry are essential to translating knowledge from research to patients. And we believe that academia and industry have much to learn and teach each other. But the learning and teaching has to be free of marketing or influence and focused on truly improving the lives of the patients we serve and the students and physicians we educate. We are now entering a new relationship and I am encouraged that this can be a new beginning ' and a novel rebooting.”

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