Ya gotta Read it to believe it Whole article Viagra and Lung

[RandyW]

Viagra Saves Kids' Lungs, Sparks Push for Pediatric Drug Tests

By Angela Cullen

Sept. 20 (Bloomberg) -- Dr. Mike Stevens doesn't have many medicines specifically designed to treat his young cancer patients. The U.K.-based professor of pediatric oncology relies on adult drugs, many of which are decades old.

The practice carries some risk. Incorrect dosing is the most commonly reported error in pediatric health care. More than half of medicines administered to children, including diluted Viagra used to treat infants with lung defects, haven't been approved for young people, according to European Union statistics.

EU lawmakers, following the U.S.'s lead, are trying to change that. They passed rules in June that require companies seeking approval for new medicines to include pediatric data when a treatment may benefit young patients. Legislators increased their scrutiny of the issue after a 2004 study showed adult anti- depressants doubled the risk of suicidal thoughts in kids.

``Children deserve the same right to innovative therapies as adults,'' said Stevens, who works at the Bristol Royal Hospital for Children. He often has to tell parents how to split tablets for their children to get the right dose. ``We use a whole range of drugs that aren't actually licensed for them.''

In Europe, as in the U.S., companies will earn six months' extra patent protection for drugs that are already approved by doing additional research on use in children. With products that generate 1 billion euros ($1.27 billion) in sales a year, that could mean as much as a 500 million-euro bonus.

The EU rules are scheduled to take effect in January, nine years after the U.S. Food and Drug Administration started enforcing its regulations.

Published Findings

The plan, which still needs approval by the EU's member states, requires that the results of pediatric clinical trials be published in a central database accessible to doctors. Companies also will be asked to submit any reports they've already done on their drugs' use in children.

The FDA only publishes summaries of pediatric research on its Web site, which doesn't give doctors enough information, said Dr. Daniel Benjamin Jr. of Duke University in Durham, North Carolina. He led a group of researchers that found only about half the findings are being published in peer-reviewed journals.

``Physicians need to understand the full breadth of the trial,'' Benjamin said. ``A summary can never replace a full understanding.''

Amendments could be made to the U.S. rules, which are up for renewal next year, to make sure doctors receive the information they need to treat children, the researchers wrote in the Sept. 13 edition of the Journal of the American Medical Association.

Cancer, Lung Defects

Even without widespread dissemination of study results, the six-month extension ``has been successful in encouraging drug studies in children,'' resulting in more than 100 changes in prescription labels to give doctors more information, Benjamin and his team wrote.

``The Europeans have worked with the U.S. to learn from what we have done,'' Benjamin said. ``I think the Europeans have improved on the process.''

The lack of clinical tests in children means doctors often use trial and error to find the correct dosage.

Viagra, Pfizer Inc.'s male impotence treatment, is being used to save the lives of newborns with lung defects. The tablet is crushed and a portion dissolved in water before the drug is given to the babies to reduce blood pressure in the lungs. New York-based Pfizer is conducting trials on the use of Viagra in 1 to 16-year-olds.

Physicians use numerous adult medicines, including cancer treatments vincristine and cyclophosamide, in unregulated ways to try to save the lives of desperately ill children.

There are between 1,500 and 1,600 new cases of cancer diagnosed among children each year in the U.K., while the number of adult cases annually is 200 times that, Stevens said.

Paxil and Prozac

``Anything we can do to make drug development for children more attractive for the industry is important, largely because the market share is going to be relatively small,'' Stevens said.

Prescriptions of antipsychotic drugs to children rose fivefold from 1993 to 2002, a June 5 study in Archives of General Psychiatry showed. The drugs are only approved for use in adults.

The journal in March published the findings of a 2004 study used by U.S. regulators to restrict prescriptions of such drugs, including Eli Lilly & Co.'s Prozac and GlaxoSmithKline Plc's Paxil. Researchers found that the drugs appeared to double the risk of suicidal thoughts and actions in children who took them.

On June 6, the European Medicines Agency ordered additional safety trials on Prozac, after clearing the drug for use in children who haven't responded to psychological treatment.

Testing Children

One hurdle to clinical tests in children is that young people can't give informed consent to participate in the tests. Because of this, the studies emphasize helping the participants.

``Kids usually have to get some kind of benefit or potential benefit from being in the study,'' Benjamin said.

The FDA says children can be included in trials including placebos when there are no approved or adequately studied therapies available.

Basel, Switzerland-based Roche Holding AG, the world's largest maker of cancer therapies, is examining ways to include children in trials for new cancer drugs.

``Children are not guinea pigs, but there has been a change of mindset,'' said Klaus Rose, Roche's head of pediatric research. ``In the past, the approach was children should be protected from research. Now the approach is they should be protected through research.''

To contact the reporter on this story: Angela Cullen in Frankfurt at Acullen8@bloomberg.net