Drug & Device News

Injunction, Then Short Supplies, Block New York Flu Vaccine Order

In Patterson v. Daines, 8830-09, Acting Supreme Court Justice Thomas J. McNamara, sitting in Albany, granted the plaintiff Public Employees Federation's request for a preliminary injunction against the State of New York's August 2009 order that all health care field workers receive flu inoculations by November or be subject to dismissal. The union sued to stop the mandate, arguing that New York Health Commissioner Richard Daines was without authority to impose the new requirement, which applied not only to the H1N1 inoculation, but also to vaccines against regular seasonal flu strains.

Soon after that decision, the issue became a non-issue, as the State's Health Commissioner rescinded his vaccination order on Oct. 22 because of a shortfall of the doses of flu vaccine necessary to cover all the workers who would need it. New York's Governor David A. Patterson announced the change in policy, stating, “Over the last week, the Centers for Disease Control and Prevention (CDC) acknowledged that New York would only receive approximately 23% of its anticipated vaccine supply by the end of the month. As a result, we need to be as resourceful as we can with the limited supplies of vaccine currently coming into the State and make sure that those who are at the highest risk for complications from the H1N1 flu receive the first vaccine being distributed right now in New York State.” The high-risk population Gov. Patterson referred to includes pregnant women, young people and those who care for small children.

Feds Give Breathing Room to Legal Medical Marijuana Dispensaries

During the Bush presidency, federal investigators and prosecutors were encouraged to pursue and prosecute state-legalized medical marijuana dispensaries and the patients who patronized them, sparking disputes over states' rights vs. federal powers. That policy was officially reversed on Oct. 19 when the U.S. Department of Justice (DOJ) issued a memorandum to federal prosecutors in states that have enacted laws authorizing the medical use of marijuana. It informed prosecutors that, while the United States is still dedicated to rooting out illegal drug trafficking and use, they should not focus federal resources on those whose actions are in compliance with state medical marijuana statutes. “For example,” said the memo's authors, “prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen consistent with applicable state law, or those caregivers in clear and unambiguous compliance with existing state law who provide such individuals with marijuana, is unlikely to be an efficient use of limited federal resources.” Thirteen states currently permit the use of marijuana for medicinal purposes. The DOJ memorandum can be accessed at: http://blogs.usdoj.gov/blog/archives/192.

Also on the medical marijuana front, the American Medical Association in October reversed its hard-line official view that marijuana has no medical value. The AMA did not go so far as to endorse the use of marijuana for therapeutic purposes, nor to recommend that its use be legalized. The group does, however, want to open the door for the medicinal qualities of marijuana to be studied in clinical trials. The AMA's release on its new recommendations can be accessed at: http://www.ama-assn.org/ama/no-index/about-ama/13625.shtml.

Patients Want End to Ban On Paying for Bone Marrow

On Oct. 26, a group of cancer patients and their caregivers filed a lawsuit seeking to have declared unconstitutional the federal prohibition against compensating bone marrow donors. The suit, filed in the U.S. District Court for the Central District of California, seeks to enjoin the U.S. Attorney General from enforcing the provisions of the National Organ Transplant Act of 1984 that keep those who need bone marrow transplants from offering a monetary incentive to donors. The plaintiffs argue that bone marrow donations frequently offer blood disease victims their only chance for survival, while comparatively only minimally inconveniencing donors. That is because bone marrow, unlike most other donated organs and tissues, replenishes itself just weeks after it is extracted.

The number of registered potential donors is currently too small to provide matches for many of the patients who need bone marrow donations. Referring to the need to expand this pool of donors, the complaint states, “This constitutional challenge is about an arbitrary law that criminalizes a promising effort to save lives.” The plaintiffs are seeking the right to make small payments to donors, perhaps by offering them college scholarships or making a mortgage payment for them. “The point is to make more people sign up,” says Jeff Rowes of the Arlington, VA-based Institute for Justice, the plaintiffs' lead attorney. “Offering a college student a scholarship for donating bone marrow shouldn't send you to prison for five years. The problem right now, especially for racial and ethnic minorities, is it's very hard to find an unrelated bone marrow donor.”

Czech Vaccine Effectiveness Study Says 'Hold the Fever Meds'

Researchers in the Czech Republic report that children who are given acetaminophen following vaccination may be getting less protection than those who forego medication to reduce pain and fever post-vaccination. Prymula, Roman, M.D., et al., Effect of Prophylactic Paracetamol Administration At Time of Vaccination on Febrile Reactions and Antibody Responses in Children: Two Open-Label, Randomised Controlled Trials. The Lancet, Vol. 374, Issue 9698, pp. 1339-1350, 17 October 2009. The researchers' theory for why children given medications on a prophylactic basis following inoculation get less protection from their vaccines is this: The immune response produces fever, and without that fever the body is less able to produce the antibodies that build resistance to disease. The study's authors recommend that medical care providers stop routinely telling those receiving vaccines to take fever-reducing medications immediately following inoculations. Such medications should be taken only when necessary, they say.

Byetta Label Changes Highlight Possibility of Kidney Problems

Acting on new safety information about possible kidney function problems associated with the use of Type-2 diabetes drug Byetta, the FDA and the drug's manufacturer have updated Byetta's label. The move came after the FDA received 78 reports of problems with kidney function in patients using the drug. “Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.” Label change information can be found at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafe tyInformationforHeathcareProfession als/ucm188656.htmm.

Injunction, Then Short Supplies, Block New York Flu Vaccine Order

In Patterson v. Daines, 8830-09, Acting Supreme Court Justice Thomas J. McNamara, sitting in Albany, granted the plaintiff Public Employees Federation's request for a preliminary injunction against the State of New York's August 2009 order that all health care field workers receive flu inoculations by November or be subject to dismissal. The union sued to stop the mandate, arguing that New York Health Commissioner Richard Daines was without authority to impose the new requirement, which applied not only to the H1N1 inoculation, but also to vaccines against regular seasonal flu strains.

Soon after that decision, the issue became a non-issue, as the State's Health Commissioner rescinded his vaccination order on Oct. 22 because of a shortfall of the doses of flu vaccine necessary to cover all the workers who would need it. New York's Governor David A. Patterson announced the change in policy, stating, “Over the last week, the Centers for Disease Control and Prevention (CDC) acknowledged that New York would only receive approximately 23% of its anticipated vaccine supply by the end of the month. As a result, we need to be as resourceful as we can with the limited supplies of vaccine currently coming into the State and make sure that those who are at the highest risk for complications from the H1N1 flu receive the first vaccine being distributed right now in New York State.” The high-risk population Gov. Patterson referred to includes pregnant women, young people and those who care for small children.

Feds Give Breathing Room to Legal Medical Marijuana Dispensaries

During the Bush presidency, federal investigators and prosecutors were encouraged to pursue and prosecute state-legalized medical marijuana dispensaries and the patients who patronized them, sparking disputes over states' rights vs. federal powers. That policy was officially reversed on Oct. 19 when the U.S. Department of Justice (DOJ) issued a memorandum to federal prosecutors in states that have enacted laws authorizing the medical use of marijuana. It informed prosecutors that, while the United States is still dedicated to rooting out illegal drug trafficking and use, they should not focus federal resources on those whose actions are in compliance with state medical marijuana statutes. “For example,” said the memo's authors, “prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen consistent with applicable state law, or those caregivers in clear and unambiguous compliance with existing state law who provide such individuals with marijuana, is unlikely to be an efficient use of limited federal resources.” Thirteen states currently permit the use of marijuana for medicinal purposes. The DOJ memorandum can be accessed at: http://blogs.usdoj.gov/blog/archives/192.

Also on the medical marijuana front, the American Medical Association in October reversed its hard-line official view that marijuana has no medical value. The AMA did not go so far as to endorse the use of marijuana for therapeutic purposes, nor to recommend that its use be legalized. The group does, however, want to open the door for the medicinal qualities of marijuana to be studied in clinical trials. The AMA's release on its new recommendations can be accessed at: http://www.ama-assn.org/ama/no-index/about-ama/13625.shtml.

Patients Want End to Ban On Paying for Bone Marrow

On Oct. 26, a group of cancer patients and their caregivers filed a lawsuit seeking to have declared unconstitutional the federal prohibition against compensating bone marrow donors. The suit, filed in the U.S. District Court for the Central District of California, seeks to enjoin the U.S. Attorney General from enforcing the provisions of the National Organ Transplant Act of 1984 that keep those who need bone marrow transplants from offering a monetary incentive to donors. The plaintiffs argue that bone marrow donations frequently offer blood disease victims their only chance for survival, while comparatively only minimally inconveniencing donors. That is because bone marrow, unlike most other donated organs and tissues, replenishes itself just weeks after it is extracted.

The number of registered potential donors is currently too small to provide matches for many of the patients who need bone marrow donations. Referring to the need to expand this pool of donors, the complaint states, “This constitutional challenge is about an arbitrary law that criminalizes a promising effort to save lives.” The plaintiffs are seeking the right to make small payments to donors, perhaps by offering them college scholarships or making a mortgage payment for them. “The point is to make more people sign up,” says Jeff Rowes of the Arlington, VA-based Institute for Justice, the plaintiffs' lead attorney. “Offering a college student a scholarship for donating bone marrow shouldn't send you to prison for five years. The problem right now, especially for racial and ethnic minorities, is it's very hard to find an unrelated bone marrow donor.”

Czech Vaccine Effectiveness Study Says 'Hold the Fever Meds'

Researchers in the Czech Republic report that children who are given acetaminophen following vaccination may be getting less protection than those who forego medication to reduce pain and fever post-vaccination. Prymula, Roman, M.D., et al., Effect of Prophylactic Paracetamol Administration At Time of Vaccination on Febrile Reactions and Antibody Responses in Children: Two Open-Label, Randomised Controlled Trials. The Lancet, Vol. 374, Issue 9698, pp. 1339-1350, 17 October 2009. The researchers' theory for why children given medications on a prophylactic basis following inoculation get less protection from their vaccines is this: The immune response produces fever, and without that fever the body is less able to produce the antibodies that build resistance to disease. The study's authors recommend that medical care providers stop routinely telling those receiving vaccines to take fever-reducing medications immediately following inoculations. Such medications should be taken only when necessary, they say.

Byetta Label Changes Highlight Possibility of Kidney Problems

Acting on new safety information about possible kidney function problems associated with the use of Type-2 diabetes drug Byetta, the FDA and the drug's manufacturer have updated Byetta's label. The move came after the FDA received 78 reports of problems with kidney function in patients using the drug. “Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.” Label change information can be found at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafe tyInformationforHeathcareProfession als/ucm188656.htmm.