A committee of the Institute of Medicine issued a report on comparative effectiveness research for medical treatments which lists 100 priority topics for review. The IOM’s list, released Tuesday, includes recommendations to compare treatment strategies in the US for atrial fibrillation, inflammatory diseases, prostate cancer, Alzheimer’s disease and attention-deficit hyperactivity disorder, among other health conditions and health-related topics.

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The report is intended to provide guidance for spending a portion of the $1.1 billion in economic-stimulus funds provided by the US government for such research. Commenting on the matter, Kathleen Buto, vice president for health policy at Johnson & Johnson, stated that “comparative effectiveness research should inform medical decisions and not replace medical judgement or be used to limit treatment choices.” She added that “the ultimate decision about which treatment or intervention is best for a particular individual should remain between a doctor and patient based on real-world data and analyses.”

Meanwhile, panel co-chairman Harold Sox, who is also the editor of the Annals of Internal Medicine, said “healthcare decisions too often are a matter of guesswork, because we lack good evidence to inform them.” He also remarked that medical-product manufacturers had a “muted” response to the panel’s efforts to prioritise the funding, noting that of the approximately 2000 public comments and recommendations the panel received, 28 came from makers of drugs, biologic products or medical devices.

Drugmakers have recently bolstered lobbying efforts aimed at deterring the US government from using comparative drug studies as a possible means of reducing healthcare costs.

Source: FirstWord

Popularity: 2% [?]

Healthy people should be able to take the anti-hyperactivity drug Ritalin to boost brain power, a UK ethicist says.

Bioethics expert Professor John Harris, of the University of Manchester, said if the drug was safe for children, adults should also be able to take it.

Writing on the British Medical Journal website, he said many students were already using the drug – which is illegal without prescription in the UK.

A US expert said there were too many risks for it to be more widely used.

Ritalin, also known as methylphenidate, is given to children with ADHD – attention deficit hyperactivity disorder.

Many doctors say it can help children control their behaviour and perform better at home and school.

If not prescribed, Ritalin is a class B drug in the UK, meaning possession can lead to a five-year prison sentence and dealing could put you behind bars for 14 years.

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But there is increasing evidence that healthy adults, especially students, are using it to enhance their mental ability.

‘Synthetic sunshine’

Professor Harris said Ritalin’s benefits included enhanced study skills and concentration.

He said it was “unethical” to stop healthy people from taking the drug and that there was evidence it was safe to use.

And he added: “Safe always means safe enough and since no drugs are free of side effects, that always means the consumer has judged the risks of adverse effects worth taking, given the probable benefits.”

Professor Harris said that if it was safe for children to use Ritalin over a long period of time for a condition that was not usually life-threatening, there was no reason to prevent healthy adults using it too.

He said it was “not rational” to be against human enhancement and likened using drugs to enhance brain power to the use of “synthetic sunlight” – firelight, lamplight and electric light.

“Before synthetic sunshine people slept when it was dark and worked in the light of day.

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“With the advent of synthetic sunshine, work and social life could continue into and through the night, creating competitive pressures and incentives for those able or willing to use it to their advantage.”

Pressure

But Professor Anjan Chatterjee, of the University of Pennsylvania, said there were too many risks in taking Ritalin unless a person was actually ill.

He said the US Food and Drug Administration had labelled it with a “black box” – the most alarming of possible warnings – because of its high potential for abuse, dependence, risk of sudden death and serious adverse effects on the heart.

Professor Chatterjee questioned whether children at top schools would take Ritalin in “epidemic proportions” and if people such as pilots, police officers and on-call doctors would be pressurised into taking the drug to perform better.

Again writing in the BMJ, he said: “Endorsing the legal non-therapeutic use of methyphenidate or other cognitive enhancers now is premature.

“The efficacy and risks of enhancers in healthy people needs to be researched adequately and this information needs to be disseminated broadly.

“Until such preparations are made, it is not acceptable to recommend that healthy people take drugs to enhance performance.”

Source: BBC NEWS

Popularity: 3% [?]

Findings published in the American Journal of Psychiatry suggest that there may be an association between stimulants used to treat attention-deficit hyperactivity disorder and sudden death in healthy children. Commenting on the results, the FDA stated that given the study’s limitations, the agency is “unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children.”

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In the retrospective study, researchers compared cases of sudden unexplained death in 564 healthy children with 564 children who died as passengers in motor vehicle accidents. Of the cases of unexplained deaths, 10 were found to have been treated with stimulants, compared with two in the motor vehicle accident group.

The FDA, in a communication about an ongoing safety review, highlighted several limitations to the study including the low frequency of stimulant use reported in both study groups, and “a significant time lag between the dates when the deaths occurred and collection of the data.” The agency, which helped fund the study, added that it is “continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children.”

Source: FirstWord

Popularity: 2% [?]

New follow-up data from a National Institute of Mental Health (NIMH) study in children with attention-deficit hyperactivity disorder confirmed that there were no long-term differences in behavioural outcomes between those who were treated with drugs and those who were not, The Washington Post reported. One of the study’s authors, Brooke Molina, remarked that the data do not “support that children who stay on medication longer than two years have better outcomes than children who don’t.”

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The Multimodal Treatment Study of Children with ADHD (MTA) randomly assigned patients to receive one of four treatment options: drug treatment, drugs plus talk therapy, talk therapy alone, or routine medical care alone. An initial 14-month analysis published in 1999 demonstrated that children treated with drugs showed more improvement in their symptoms than their counterparts who received only talk therapy or routine care. However, a follow-up analysis in 2007 no longer showed differences in behaviour between children treated with drugs and those who were not. In addition, the data from 2007 indicated that children who took ADHD drugs for 36 months were shorter and weighed less than those who did not receive drugs.

The latest findings, published in the Journal of the American Academy of Child and Adolescent Psychiatry, include data from an eight-year follow-up of the patients and confirmed that there were no long-term differences in behaviour between those who were treated with drugs and those who were not. Researcher William Pelham concluded that one interpretation of the data is that the ADHD drugs are useful in the short term but ineffective over the long-term.

Meanwhile, co-author Peter Jensen said that looking at overall results was not as useful as examining the results for particular groups of children and suggested, along with co-author Benedetto Vitiello, that ADHD drugs may not have demonstrated an overall long-term benefit because the quality of routine care may have been inferior to that given during the initial part of the study.

Source: FirstWord

Popularity: 2% [?]

Cortex Pharmaceuticals is planning on reducing its workforce by approximately 50%. While reducing basic research and preclinical efforts, the company is focusing on mid-stage candidates for sleep apnea, depression, and attention-deficit hyperactivity disorder (ADHD).

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CX717 is in Phase II testing for opioid-induced respiratory depression, and CX1739 is in a Phase II sleep apnea study with expected completion around mid-2009. CX1739 will also enter a Phase II trial in ADHD adult patients around mid-year.

Both compounds are also being tested in Alzheimer’s disease, which according to Mark Varney, Ph.D., president and CEO, will be evaluated in the long term.

Cortex says that a third compound, CX1942, will advance into toxicology and Phase I trials over the next year when additional capital becomes available. This molecule has shown potential in respiratory depression and sleep apnea. Similarly, CX2007will be evaluated in ADHD and Alzheimer’s disease when the company has further resources.

Source: GEN News

Popularity: 2% [?]

Shire announced on Monday that the company is withdrawing its application to market attention-deficit hyperactivity disorder patch Daytrana (methylphenidate) in Europe, after regulators requested that an additional study be conducted in a European patient population.

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The drugmaker indicated that it will enter the EU market for ADHD through its previously announced pending licensing of UCB’s Equasym (methylphenidate) IR and XL, an oral product which is already approved in Europe as an ADHD treatment for children over six.

The company indicated that its decision to withdraw Daytrana from EU consideration will not impact its “commitment to Daytrana in the US,” where the patch has been approved as a paediatric treatment for ADHD since 2006.

Source: FirstWord

Popularity: 2% [?]