Washington Editor

The FDA is taking a proactive approach to better data collection for possible psychiatric adverse effects for certain types of drugs.

However, the agency said there is no requirement that it be done in all clinical trials. Rather, on a case-by-case basis, the agency may ask a drug sponsor to collect and categorize data on psychiatric adverse effects during clinical trials if the FDA thinks there might be a cause for concern.

"These determinations are based on factors such as the class of the drug, what may be known from other members of the class, findings from animal studies or signals of imbalances in psychiatric adverse events reported in controlled clinical trials," spokeswoman Crystal Rice said in an e-mail response. The FDA said it may ask manufacturers to either prospectively collect and assess such information or retrospectively request drugmakers to further analyze adverse event data.

Rice emphasized that "this type of data collection and analysis is not new, rather FDA has been looking at this for some time for certain types of drugs."

A Jan. 24 New York Times article reported the FDA has instituted "new rules" requiring drugmakers to include a comprehensive suicide assessment in clinical trials. The Times called the rules "one of the most profound changes of the past 16 years to regulations governing drug development."

The newspaper asserted that since the FDA's oversight of new drugs is done in secret, that the "agency's shift has not been announced publicly."

But Rice insisted that there is no such new regulation or policy change in which the FDA is requiring drugmakers to assess psychiatric adverse effects of all new drugs. She noted that the FDA is bound by law to keep drug and biologic approval applications confidential.

"As the science continues to evolve, FDA is taking a proactive approach during the entire lifecycle of a drug product to help ascertain any drug safety signals that may arise," Rice said.

10 Diseases Cost $500B

The nation's 10 most expensive medical conditions cost the U.S. about $500 billion to treat, according to the Agency for Healthcare Research and Quality (AHRQ).

The $500 billion paid for visits to doctor's offices, clinics and emergency departments, hospital stays, home health care and prescription medicines, AHRQ researchers recently reported.

Heart conditions ranked the highest, with the nation spending about $76 billion in 2005, the most recent year for which data are available. Trauma disorders ranked second with $72 billion spent followed by cancer at $70 billion.

The U.S. spent about $56 billion in 2005 treating mental disorders, including depression, AHRQ said. Pulmonary conditions, such as asthma and chronic obstructive pulmonary disease, cost the nation $54 billion, while the nation spent about $42 billion treating high blood pressure.

The costs to treat Type II diabetes, a condition that has grown to epidemic proportions in the U.S. in recent years, were at $34 billion in 2005. The nation also spent $34 billion treating joint diseases, such as osteoarthritis. Back problems and child birth expenses cost the nation $32 billion each in 2005, AHRQ reported.

Vytorin Probed by Congress, FDA

Sen. Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, is investigating why it took Kenilworth, N.J.-based Schering-Plough Corp. and Whitehouse Station, N.J.-based Merck & Co. about 18 months to release results of a trial comparing the effectiveness of Vytorin, a cholesterol-lowering drug containing a combination of Zetia (ezetimibe) and Zocor (simvastatin), with simvastatin alone.

The Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia trial, or ENHANCE, was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin or simvastatin.

Results of the study, which was completed in April 2006, showed that Vytorin performed no better than simvastatin, which can be purchased at about half the price of Vytorin.

Grassley has asked the drugmakers to account for sales and payments made for the cholesterol drug Vytorin to Medicaid.

"In Iowa City, generic simvastatin costs $54.54 for a month's supply while Vytorin costs $112.46," Grassley said in a statement. "It's fair to assume the public would have benefited from knowing that a less expensive drug works just as well. Instead, people in Iowa and elsewhere paid more for nearly two years while industry leaders sat on a scientific study that would have revealed this information."

The FDA Friday said it would review the final results of the ENHANCE study. However, said John Jenkins, director of the FDA's Office of New Drugs, it may be several weeks, even months, before the agency receives those results, and it will take regulators another six months to complete its analysis. But, he added during a late Friday afternoon media briefing, "it could be much sooner than that."

Jenkins said it is not clear why the lower levels of low-density lipoprotein, or LDL, cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared with patients treated with simvastatin alone.

He urged patients not to overreact to the study's results and to consult their physicians about the use of Vytorin.

Jenkins said he could not account for why Schering-Plough and Merck waited 18 months to divulge the study's results, only stating that it was not an uncommon practice to do so.

The two drugmakers Friday defended the late release of the ENHANCE results, stating that while the trial was "time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial."

ENHANCE was a two-year, multinational, randomized, double-blind study conducted in 720 patients with heterozygous familial hypercholesterolemia, a condition that is associated with very high cholesterol levels and affects about 0.2 percent of the population.