That's why today's news is so important: an independent committee assigned to watch over Arena's drug study has said that it is ethical to keep giving patients the drug.
Dodd , a Democrat, is proposing a sweeping set of drug reforms that would give the Food and Drug Administration the muscle to force pharmaceutical companies to study drug safety after the medicines are approved.
German drug giant Bayer failed to tell the U.S. Food and Drug Administration of a study that connected a controversial heart surgery drug to dangerous side effects and death, even as FDA convened a panel of experts to evaluate the drug's safety.
Six-month patent extensions are automatically granted to drug companies who study their drugs in children.
"It's unheard of for drug companies to study something in a small population, " she says.
Psychiatrist Arif Khan has spent years trying to convince drug companies to study their antidepressants and psychiatric drugs in suicidal patients.
FORBES: The Sick Patients Glaxo, Pfizer, and Lilly Refuse To Help
In the Merck study, there were 11 deaths in patients on the study drug and 8 deaths among patients who got placebo.
In the near-term, that could allow pharmaceutical researchers to better study drug interaction, and one day such tissue might be implanted in a live person, allowing treatment or diagnosis.
ENGADGET: Harvard scientists grow human cells onto nanowire scaffold to form 'cyborg' skin
But Robert Harrington, a well-known Duke University Medical Center cardiologist, thought that the good and bad results from the drug made the study neutral, meaning there was no clear benefit from the medicine.
Second, keeping drugs out of the hands of children is the best way to prevent drug addiction generally, as study after study has confirmed that if we keep a child drug free until age 21, the chances of use in adulthood are next to zero.
FORBES: Bill Bennett: Still a Drug Warrior After All These Years
The FDA warning comes after the agency reviewed a study on the drug that was published last May in the New England Journal of Medicine, as well as another study by a manufacturer of the antibiotic.
Kenneth Kaitin, the director of the Tufts Center for the Study of Drug Development, believes there has been a paradigm shift.
The Tufts Center for the Study of Drug Development says that number will rise to 65% within three years.
Groups such as the Institute for the Study of Drug Dependence say that amphetamine use is actually falling, despite its association with the club scene.
Further complicating comparisons, and not part of the study, drug companies often work to help patients with these out-of-pocket (and bank account, and mortgage) costs.
FORBES: U.S. Patients Get Access To More Cancer Drugs, But Pay For The Privilege
He points out that of 521 patients who took the drug in a safety study, 2 had forms of sleep paralysis, which can be a symptom of narcolepsy.
FORBES: Can A Safer Ambien Make Billions? Merck Aims To Find Out
This has been a tough thing to pull off but Seattle Genetics says it has been told by the Food and Drug Administration that its study could be sufficient for an approval, despite its small size.
FORBES: Seattle Genetics Scores Win For Smart-Bomb Cancer Drugs
The failure of Zimulti (formerly known as Acomplia) resulted partly from the company's decision to study the drug mainly in obesity trials where many patients dropped out, making it more difficult to judge the drug's risks.
Ironically, a study by Tufts Center for the Study of Drug Development economist Joseph DiMasi and Duke University professor Henry Grabowski found that between 1990 and 2005, 47% of oncology drugs received accelerated approval compared with 13% for all other drug classes.
FORBES: Media White-wash Flawed Study Of Cancer Drug Approvals
The U.S. approved 33% more new cancer drugs than European nations including the United Kingdom, France, and Germany between 2000 and 2011, and approved them much faster as well, according to new research released today by the Tufts Center for the Study of Drug Development.
FORBES: U.S. Patients Get Access To More Cancer Drugs, But Pay For The Privilege
In addition to a study of 13, 000 patients that will be used to convince the FDA to approve the drug, Novartis is conducting an 18, 000-patient outcome study to try and demonstrate that its drug does not cause an increased risk, however rare, of heart attack.
Merck also announced it had canceled a mid-stage study of its migraine drug telcagepant, viewed as promising, because of elevated levels of liver enzymes in study participants.
Bristol, not Pfizer, funded that study, which backfired (see: " Bristol Study Proves Rival Drug Better").
The FDA has required Vivus to do a study on the drug's cardiovascular effects.
The study of that drug, called Bolero-2, involved 724 women with cancers fueled by the hormone estrogen.
The warning was based on an NIH study testing the drug as a preventative in Alzheimer's disease.
Bristol-Myers Squibb got some exciting news from a study on experimental drug ipilimumab.
This included a large number of newly diagnosed patients, 13% of whom were found to be multi-drug-resistant, the study said.
WSJ: Tuberculosis Strain in Mumbai Doesn't Respond to Main Treatment
The Atlas (Assessment of Treatment with Lisinopril and Survival) study found the drug is much more effective if the dose is increased.
应用推荐