Drug & Device News

Early Public Disclosure of Suspected Drug Safety
Issues Begins

In September, the U.S. Food and Drug Administration (FDA) published the first of its planned quarterly reports listing the drugs that are under evaluation by the agency for potential safety problems. The new reporting system was imposed on the FDA by legislation signed into law a year ago as part of the Food and Drug Administration Amendments Act of 2007. Under the law, the FDA is required to inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in the FDA's Adverse Event Reporting System (AERS).

The agency pointed out in a release that the fact that a drug is on the list does not mean that the FDA has concluded it is unsafe or that the agency has identified a causal relationship between the drug and the listed risk. Inclusion on the list merely means that further investigation into possible problems with the drug is in order. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, emphasized this point by saying, “My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.“ The list can be found at: http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm.

Autism/MMR Link Discredited Once Again

Many studies have debunked the theory that autism is caused by the combination measles, mumps and rubella inoculation (MMR) young children routinely receive. However, one study published in a 1998 edition of Britain's prestigious medical journal The Lancet did find a link between the vaccination and gastrointestinal problems that the study said led to autism. The theory advanced by that study's authors was that the virus used to inoculate children could enter a child's intestinal tract, where it could grow and make the bowel porous. The bowel would then release some of its contents into the bloodstream, harming the nervous system and causing autism. But in a new study whose results were published in PloS ONE, researchers who replicated the conditions of the 1998 study came up with no evidence of a correlation between MMR shots and the onset of gastrointestinal problems and/or autism. Hornig M, et al. (2008) Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. PLoS ONE 3(9): e3140. doi:10.1371/journal.pone.0003140. The PloS ONE article can be found at: http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0003140.

Medical Marijuana Proponents Win a Round

The U.S. District Court for the Northern District of California, San Jose Division, recently refused to dismiss a suit against the federal government for selectively enforcing its drug laws against legal medical marijuana users and prescribers, as such enforcement may constitute violation of the 10th Amendment to the Constitution.

After some states legalized the use of marijuana for medical purposes, the federal government began fighting such legalization by prosecuting various players in states' authorized distribution mechanisms, including prescribers and landlords who rent office space to medical marijuana dispensaries. Suits to stop federal government harassment of legal marijuana distributors and consumers have been largely unsuccessful, with courts generally finding that, notwithstanding any state law to the contrary, the federal government still had the right to enforce its overarching federal drug laws.

The judge in County of Santa Cruz v. Gonzales, C 03-01802 JF, Justice Jeremy Fogel, noted that under the Tenth Amendment, “Congress may not simply commandeer the legislative process of the States by directly compelling them to enact and enforce a federal regulatory program. New York v. U.S., 505 U.S. 144, 161 (1992) (internal quotations omitted).” Plaintiffs alleged that federal authorities were trying to force California to enforce federal law by deliberately frustrating the State's ability to determine whether an individual marijuana dispenser or user was complying with state law. This the United States did by, among other things, threatening physicians who recommended marijuana use and threatening government officials who issue medical marijuana identification cards. Although offering no opinion as to whether the federal government's actions had indeed “commandeered the legislative process” of the State of California, the district court said the plaintiffs had offered adequate evidence that federal officials may have “devised a strategic plan of targeted enforcement that has had the intended effect of 'rendering California's medical marijuana laws impossible to implement and thereby forcing California and its political subdivisions to recriminalize medical marijuana.'” (Quoting plaintiffs' second amended complaint.) Thus, the United States' motion to dismiss the claim was denied and the suit may move forward.

Judge Rejects Free Speech Defense to Off-Label Drug Promotion Charge

Noting that the federal government's ban on drug manufacturers' promotion of off-label drug uses “appear[s] essential to maintaining the integrity of the [U.S. Food and Drug Administration]'s new drug approval process,” Eastern District Judge Eric N. Vitaliano in September refused to dismiss a case against a drug sales representative on the ground that ' 301 et seq. of the Food, Drug, and Cosmetic Act violated his First Amendment right to free speech. Sales rep Alfred Caronia says he was contacted several times by a doctor who wanted information about the off-label uses of Xyrem, a medication manufactured by Orphan Medical Inc. to treat narcolepsy. Caronia's brief claims that a doctor, who turned out to be an informant, “repeatedly asked Mr. Caronia off-label questions,” and asked to meet Dr. Peter Gleason, a physician Caronia had used previously to promote the drug. In November 2005, Caronia introduced the two doctors, who discussed Xyrem while Caronia, according to his brief, “sat silently.” Caronia said he believed that Dr. Gleason, as a physician, was not prohibited from discussing off-label uses of the medication with another physician. Dr. Gleason, who was also indicted on felony charges of conspiracy to misbrand Xyrem, pleaded guilty to a single misdemeanor count. The case, U.S. v. Caronia, 06-CR-229, is being heard in Brooklyn.

Drug Companies Will Disclose Doctors' Financial Ties

Two pharmaceuticals giants have announced plans to publicly disclose the extent of physician financial connections to their companies. Eli Lilly & Co. and Merck & Co. will make public the amount of speaking fees they give to doctors beginning in 2009. Eli Lilly will also publish in its forthcoming online database the amount of monies paid to doctors for consulting services. Congress is set to consider a bill next year that would require drug manufacturers to make disclosures such as these, but Eli Lilly's and Merck's moves toward greater transparency in advance of a legislative mandate to do so may prove a public relations coup.

Early Public Disclosure of Suspected Drug Safety
Issues Begins

In September, the U.S. Food and Drug Administration (FDA) published the first of its planned quarterly reports listing the drugs that are under evaluation by the agency for potential safety problems. The new reporting system was imposed on the FDA by legislation signed into law a year ago as part of the Food and Drug Administration Amendments Act of 2007. Under the law, the FDA is required to inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in the FDA's Adverse Event Reporting System (AERS).

The agency pointed out in a release that the fact that a drug is on the list does not mean that the FDA has concluded it is unsafe or that the agency has identified a causal relationship between the drug and the listed risk. Inclusion on the list merely means that further investigation into possible problems with the drug is in order. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, emphasized this point by saying, “My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.“ The list can be found at: http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm.

Autism/MMR Link Discredited Once Again

Many studies have debunked the theory that autism is caused by the combination measles, mumps and rubella inoculation (MMR) young children routinely receive. However, one study published in a 1998 edition of Britain's prestigious medical journal The Lancet did find a link between the vaccination and gastrointestinal problems that the study said led to autism. The theory advanced by that study's authors was that the virus used to inoculate children could enter a child's intestinal tract, where it could grow and make the bowel porous. The bowel would then release some of its contents into the bloodstream, harming the nervous system and causing autism. But in a new study whose results were published in PloS ONE, researchers who replicated the conditions of the 1998 study came up with no evidence of a correlation between MMR shots and the onset of gastrointestinal problems and/or autism. Hornig M, et al. (2008) Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study. PLoS ONE 3(9): e3140. doi:10.1371/journal.pone.0003140. The PloS ONE article can be found at: http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0003140.

Medical Marijuana Proponents Win a Round

The U.S. District Court for the Northern District of California, San Jose Division, recently refused to dismiss a suit against the federal government for selectively enforcing its drug laws against legal medical marijuana users and prescribers, as such enforcement may constitute violation of the 10th Amendment to the Constitution.

After some states legalized the use of marijuana for medical purposes, the federal government began fighting such legalization by prosecuting various players in states' authorized distribution mechanisms, including prescribers and landlords who rent office space to medical marijuana dispensaries. Suits to stop federal government harassment of legal marijuana distributors and consumers have been largely unsuccessful, with courts generally finding that, notwithstanding any state law to the contrary, the federal government still had the right to enforce its overarching federal drug laws.

The judge in County of Santa Cruz v. Gonzales, C 03-01802 JF, Justice Jeremy Fogel, noted that under the Tenth Amendment, “Congress may not simply commandeer the legislative process of the States by directly compelling them to enact and enforce a federal regulatory program. New York v. U.S. , 505 U.S. 144, 161 (1992) (internal quotations omitted).” Plaintiffs alleged that federal authorities were trying to force California to enforce federal law by deliberately frustrating the State's ability to determine whether an individual marijuana dispenser or user was complying with state law. This the United States did by, among other things, threatening physicians who recommended marijuana use and threatening government officials who issue medical marijuana identification cards. Although offering no opinion as to whether the federal government's actions had indeed “commandeered the legislative process” of the State of California, the district court said the plaintiffs had offered adequate evidence that federal officials may have “devised a strategic plan of targeted enforcement that has had the intended effect of 'rendering California's medical marijuana laws impossible to implement and thereby forcing California and its political subdivisions to recriminalize medical marijuana.'” (Quoting plaintiffs' second amended complaint.) Thus, the United States' motion to dismiss the claim was denied and the suit may move forward.

Judge Rejects Free Speech Defense to Off-Label Drug Promotion Charge

Noting that the federal government's ban on drug manufacturers' promotion of off-label drug uses “appear[s] essential to maintaining the integrity of the [U.S. Food and Drug Administration]'s new drug approval process,” Eastern District Judge Eric N. Vitaliano in September refused to dismiss a case against a drug sales representative on the ground that ' 301 et seq. of the Food, Drug, and Cosmetic Act violated his First Amendment right to free speech. Sales rep Alfred Caronia says he was contacted several times by a doctor who wanted information about the off-label uses of Xyrem, a medication manufactured by Orphan Medical Inc. to treat narcolepsy. Caronia's brief claims that a doctor, who turned out to be an informant, “repeatedly asked Mr. Caronia off-label questions,” and asked to meet Dr. Peter Gleason, a physician Caronia had used previously to promote the drug. In November 2005, Caronia introduced the two doctors, who discussed Xyrem while Caronia, according to his brief, “sat silently.” Caronia said he believed that Dr. Gleason, as a physician, was not prohibited from discussing off-label uses of the medication with another physician. Dr. Gleason, who was also indicted on felony charges of conspiracy to misbrand Xyrem, pleaded guilty to a single misdemeanor count. The case, U.S. v. Caronia, 06-CR-229, is being heard in Brooklyn.

Drug Companies Will Disclose Doctors' Financial Ties

Two pharmaceuticals giants have announced plans to publicly disclose the extent of physician financial connections to their companies. Eli Lilly & Co. and Merck & Co. will make public the amount of speaking fees they give to doctors beginning in 2009. Eli Lilly will also publish in its forthcoming online database the amount of monies paid to doctors for consulting services. Congress is set to consider a bill next year that would require drug manufacturers to make disclosures such as these, but Eli Lilly's and Merck's moves toward greater transparency in advance of a legislative mandate to do so may prove a public relations coup.