Researchers are asking for stricter penalties and fines for those pharmaceutical companies that market drugs for “off label” promotion.  According to both Adriane Fugh-Berman, M.D., an associate professor in the GUMC Department of Physiology and Biophysics, and Douglas Melnick, M.D., a preventive medicine physician in the Los Angeles County Department of Public Health, new regulations are needed to address this practice.

Both researchers have extensive experience in the pharmaceutical industry, with Melnick having worked as a physician in industry medical affairs, which supported pharmaceutical marketing efforts and Fugh-Berman as the principal investigator of PharmedOut, a project to educate physicians about the influence that pharmaceutical companies have on drug prescribing.  The two argue that, “states and other jurisdictions have a duty to protect the health of the public.  Allowing off-label promotion of drugs for untested, unproven benefits maximizes industry profits at the expense of public health.”  While physicians can prescribe medications off-label—or for purposes other than those approved by the Food and Drug Administration (FDA)—pharmaceutical companies are legally restricted from marketing drugs for nonFDA-approved uses.  Despite this, off-label marketing is quite extensive. (more…)

The Associated Press (AP) is reporting that, according to a report from  congressional investigators, key “scientists and career employees at the Food and Drug Administration (FDA) opposed agency regulations that weaken consumers’ ability to sue drug makers.”  The question involves language used in a 2006 drug-labeling rule that “effectively limits when people can sue in state court over injury claims involving medications.”  The FDA is claiming that federal regulations “prevail” in conflicts involving state law in a concept known as pre-emption.

Internal documents revealed that career officials opposed pre-emption, according to a report released by Representative Henry Waxman, chairman of the House Oversight and Government Reform Committee.  The report also stated that, previously, the agency deemed such private lawsuits as an extra protection against unsafe drugs.  “Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis,” the report quoted Dr. John Jenkins, who oversees FDA’s new drug reviews, as saying. “We know that such an assumption is false.” (more…)

About one million Americans will undergo joint replacement surgery in the next year.  Given that, consumers might be interested to know how much money their orthopedic surgeon might be receiving from joint replacement makers.  Although some physicians may not receive funding for using a specific maker’s device, some could receive kickbacks as large as a million dollars, despite that a recent federal anti-kickback case targeted such questionable payments.

Beginning in September 2007, a criminal investigation put a temporary halt on the paychecks of several thousand doctors who were also consulting for joint replacement device makers.  In a settlement, in which they admitted no wrongdoing, the industry’s “major players” paid $311 million and agreed to federal monitoring.  The high-profile prosecution did not sever the financial ties between doctors and medical-supply companies and payouts continue.  Some experts fear that between buying out old contracts and writing new contracts under stricter compliance standards, amounts could increase; critics expect patients will face more problems because there is no way in which patients can determine how back-door financing is affecting medical care and choices.  Of deepest concern?  Doctors using a specific device or procedure for the money they will make, not for the benefits of one device or procedure over another and not for what is in the patient’s best interest. (more…)

We have long been reporting on the controversy surrounding bisphenol A—BPA—a ubiquitous chemical used to harden plastics that can be found in a wide array of consumer products, including plastic baby bottles.  BPA is also used as a coating in food cans.

Despite overwhelming skepticism and mounting evidence to the contrary, the U.S. Food and Drug Administration (FDA) recently declared the controversial, estrogenic chemical safe.  Consumer groups criticize the findings used by the FDA in the face of hundreds of scientific studies suggesting that BPA is dangerous.  It is widely known that the FDA used two industry-supported reports in coming to its conclusion.  Congress is also questioning the chemical industry’s influence in drafting an FDA report about the safety of BPA in baby bottles. (more…)

The Coast Guard hearing into last summer’s Mississippi River oil spill continued yesterday, with a deckhand testifying that the towboat Mel Oliver was in poor physical condition at the time of the accident.  David LeBlanc also offered an account of events aboard the Mel Oliver that conflicted with that given by the vessel’s other deckhand last week.

The Mississippi River oil spill occurred on July 23 when the tanker Tintomara and a barge carrying 419,000 gallons of oil – being towed by the Mel Oliver – collided. The barge split in half, spilling much of its cargo into the river. It is estimated that about 280,000 gallons of oil actually spilled into the Mississippi.  The spill was the worst to ever occur on the lower Mississippi River. (more…)

Another Tysabri patient has developed progressive multifocal leukoencephalopathy (PML), an often fatal brain disease.  Just three months ago, Biogen Idec said two additional patients had contracted PML.

PML attacks the brain and central nervous system and is usually fatal.  It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. (more…)

It seems that this year was the deadliest year in emergency medical helicopter history and, now, federal accident investigators have just announced that the air-ambulance industry and its regulators moved too slowly to stop the onslaughts of medical helicopter accidents that involved nine  crashes and 35 deaths.  As a matter-of-fact, the National Transportation Safety Board (NTSB) voted—for the first time ever—to put safety enhancements for air-ambulance flights on its annual “Most Wanted” list of suggested improvements.

Over two years ago, in January 2006, the NTSB urged the Federal Aviation Administration (FAA) to make air-ambulance flights subject to more stringent operating rules, require companies to address possible risks before each flight, and install devices that warn pilots in danger of accidentally striking the ground or other obstructions.  While some progress has been made on some of these requests, none have been fully put in place, said Jeffrey Guzzetti, deputy director of the NTSB’s aviation division.  “We need to put the foot down to the pedal.  People are dying,” NTSB board member Debbie Hersman said.  “There needs to be a sense of urgency. The fatalities are going up and up,” Hersman noted. (more…)

The E. coli outbreak in Canada’s Niagara Region has sickened up to 21 people, with six confirmed cases, and has resulted in two restaurant closures.  Over 100 food samples have been taken from Niagara-on-the-Lake’s Little Red Rooster restaurant, which was pinpointed as one possible source; two of six confirmed cases reported eating there.  The second restaurant—M.T. Bellies in Welland—voluntarily closed its kitchen yesterday; three confirmed cases ate at M.T. Bellies.  Both restaurants are located in the same province and are about 24 miles (40 kilometers) apart.  Neither restaurant has been officially linked to the growing outbreaks.

Investigators continue to work to locate the E. coli source and to determine if the restaurants are connected to the outbreak, they may share a single food supplier.  Health officials warned against jumping to conclusions.  “We need to keep an open mind and not focus on one particular food establishment as the source of illness at this stage of the investigation,” said Dr. Doug Sider, the associate medical officer of health in Niagara Region.  Dr. Sider also said that preliminary testing is indicating that the two concurrent outbreaks are not related; however, both outbreaks are of the same general strain E. coli O157:H7. (more…)

We have been reporting for some time on the negative effects of bisphenol A—BPA—as well as some slanted reporting used by the U.S. Food and Drug Administration (FDA) in their assessment deeming BPA safe.  Now, according to a report by a panel of U.S. independent scientific advisors, health regulators failed to properly assess the potential safety risks posed by BPA.

According to the group, FDA staff failed to provide “reasonable and appropriate scientific support” for its finding that the public was not at risk from BPA.  BPA has been used for decades to strengthen plastic used in baby bottles and food storage containers and has long been linked in a wide variety of studies to diabetes, heart disease, developmental changes in children, hormonal issues, problems with liver function test results, and interference with chemotherapy treatments.  The recent reproach adds to the long-running dispute among U.S. government scientists over BPA’s risks, yet the FDA does not budge from its position and continues to deem BPA safe as recently as August, relying heavily on two controversial industry studies for its data.  That announcement sparked a fury of criticism from consumer groups and lawmakers given that the findings conflicted with at least one separate report issued from the National Toxicology Program that found BPA poses a risk to children.  The group, which is part of the Health and Human Services Department, ranked the risk level for children in the middle of a five-point scale. (more…)

Bayer is in trouble with federal regulators for the way it has marketed two aspirin supplement products.  According to the Food & Drug Administration (FDA), advertisements for Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage include unproven claims.  The FDA also said the two products are being sold illegally.

Bayer Aspirin with Heart Advantage contains plant sterols and claims on its packaging to help control cholesterol, while Bayer Women’s Low Dose Aspirin + Calcium claims to help strengthen bones and prevent osteoporosis. While vitamin and herb supplements are generally not subject to FDA approval, adding them to already-approved drugs makes them entirely new products that must be subject to FDA review before being sold, the agency said. (more…)