Pharmaceutical companies hesitate to test drugs on pregnant women
WASHINGTON About 4 million Americans give birth each year, but during those nine months when the baby is developing, some mothers experience symptoms only associated with pregnancy—such as pre-clampsia, which raises the blood pressure, and cholestasis, which affects the liver—as well as mothers who had diseases before they become pregnant, such as Crohn’s disease.
According to a printed article, pharmaceutical companies are not developing drugs to help with these pregnant women because they are concerned with necessary clinical trials with new drugs and the impact that could result if the drugs were harmful to the fetus. As a result, physicians are left to prescribe, off-label, medications that sometimes have unknown side-effects for the fetus.
This also leaves doctors with the problem of using medications that have been on the market longer because more is known about the drug and the effects it has on a variety of people. There is safety in the knowledge, as compared to newer drugs, where side effects are sometimes only discovered once the drug is approved and already on the market for consumer use. The problem with prescribing these older medicines is, however, they are sometimes weaker in strength than the new medications and still leave the mother complaining about her symptoms.
Given those concerns, experts say the “drug drought” isn’t likely to end any time soon. Worldwide, scientists are actively developing only 17 medicines for maternal health, according to Nicholas Fisk, an obstetrician-gynecologist and director of the University of Queensland Centre for Clinical Research in Australia. That is fewer than 3 percent of the 660 drugs being developed for heart disease and half as many being researched for Lou Gehrig’s disease (ALS), which affects only 5,600 new patients per year.
Antibody drug found cost-effective against allergic asthma
NEW YORK A review of seven studies has found the antibody drug Xolair to be cost-effective in treating allergic asthma, according to a report published in the journal Allergy.
The report, by University of Washington researcher Sean Sullivan and Dr. F. Turk of Novartis Pharma showed that Xolair, Novartis’ brand name for omalizumab, showed the drug was cost-effective in treating allergic asthma for which common asthma medications were inadequate.
The studies also found some evidence that Xolair may not be as cost-effective in treating other forms of asthma.
Novartis and Genentech market Xolair in the U.S. Genentech reported U.S. sales of $472 million for the drug in 2007, according to Novartis financial data.
First DataBank settles lawsuit for $1 million
BOSTON First DataBank, a provider of integrated databases of information about medications, has agreed to pay $1 million to settle a lawsuit alleging it conspired with McKesson to manipulate the average wholesale price of drugs.
The case, New England Carpenters Health Benefits Fund vs. First DataBank, filed in 2005, alleges that First DataBank and McKesson “wrongfully increased the so-called wholesale acquisition cost to AWP markup factor applied to numerous prescription pharmaceuticals through a scheme begun in late 2001 and 2002,” which meant that the plaintiffs in the class action lawsuit made “substantial excess payments.”
First DataBank denies any wrongdoing or liability and “has valid and complete defenses to the claims asserted against [it] in the class action,” which it is settling to avoid the expense and inconvenience of further litigation, the settlement says.
The case, filed in the U.S. District Court for the District of Massachusetts, explicitly excludes government entities from joining the class action suit. The San Francisco Health Plan and the state of Connecticut have filed suits with similar charges that McKesson and First DataBank inflated the spread between WAC and AWP from 20 percent to 25 percent, costing state Medicaid and other health programs untold sums.
First DataBank is not named as a defendant in the two new lawsuits. McKesson continues to defend itself in all three cases.