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Antidepressant Studies Distort Drugs' Usefulness

New study says negative reports often go unpublished

(Newser) - Roughly half of the medical studies involving antidepressants that found little or no effect on patients have gone unpublished or had their findings mischaracterized as positive, a new study reveals. The emphasis on publishing only studies with glowing reviews gives patients and doctors a false sense of the effectiveness of...

FDA: Send in the Clones
FDA: Send in the Clones
Jan 15, 2008 1:06 PM CST

FDA: Send in the Clones

Agency finds no health effects, loss of nutritional value

(Newser) - Clones are just as safe to eat as any other animal, concludes a much-awaited, much-debated report from the FDA. Cloned animals studied were found to be as healthy as their normal counterparts, and their meat contained equal levels of nutrients, the Washington Post reports. The 968-page document provides mountains of...

No Right to Drugs for Dying
No Right to Drugs for Dying
Jan 15, 2008 3:30 AM CST

No Right to Drugs for Dying

Supreme Court declines to hear plea for experimental drugs

(Newser) - The Supreme Court has declined to hear what could have been a landmark case on whether terminally ill patients should be given access to experimental drugs not yet approved by the Food and Drug Administration. The decision lets stand a lower court ruling that the terminally ill have no special...

New Drug Stirs Debate Over Disease's Existence

Widely advertised Lyrica treats fibromyalgia, but some docs raise red flags

(Newser) - The first drug approved by the FDA to treat fibromyalgia is raising questions, but not the typical ones about whether the medication works. They're questions about whether the disease even exists. Lyrica sales are up and climbing, but critics say giving a name to the chronic pain that characterizes fibromyalgia...

Beefed-Up R&amp;D Slows Drug Approval
Beefed-Up R&D Slows Drug Approval
Jan 8, 2008 5:45 PM CST

Beefed-Up R&D Slows Drug Approval

Just 19 new meds cleared FDA in 2007

(Newser) - The FDA approved only 19 new drugs in 2007, the lowest total in 24 years. Bloomberg takes a look at the reasons. Some drug companies accuse the FDA of setting the bar higher for drug approvals, a charge the agency denies. Many, however, say the issue lies with big pharma...

Shots Could End Coke Addiction
Shots Could End Coke Addiction
Jan 2, 2008 8:02 AM CST

Shots Could End Coke Addiction

Vaccine stops drug from producing a high

(Newser) - Scientists have developed a potential vaccine against cocaine addiction and have asked the federal Food and Drug Administration to greenlight large-scale clinical trials. The injections of modified cocaine work by stimulating the immune system to attack cocaine when it's ingested, preventing the drug from producing a high, reports the Houston ...

Desperate Cancer Victims Turn to Do-it-Yourself Cures

Americans create risky cancer cocktails they hope will help

(Newser) - Desperate for a cure, and fed up with waiting for a federal Food and Drug Administration they say takes too long to approve drugs, some ill Americans are concocting cancer medicine "cocktails"—many of which haven’t been approved or tested—they hope will save their lives, reports...

FDA Panel Rejects Breast Cancer Drug

Uncertainties on risk sink bid to expand uses for Avastin

(Newser) - An FDA panel rejected a drug to treat advanced breast cancer by 5-to-4 vote, the Wall Street Journal reports. The drug Avastin is already used to treat colon and lung cancer, but the panel said it did not have sufficient data to weigh the risks and benefits of using the...

Honey Works on Kids' Coughs
Honey Works on Kids' Coughs
Dec 4, 2007 7:07 AM CST

Honey Works on Kids' Coughs

Study says it soothes throat, helps children sleep

(Newser) - Parents looking for an alternative to cold medicines for their young kids might consider a sweet solution—honey. A new study suggests that a commonly available dark variety soothes children's coughs and helps them sleep better, the Houston Chronicle reports.  The study comes in the wake of the FDA's...

3 Stars Means It's Healthy, Right?
3 Stars Means It's Healthy, Right?
Dec 1, 2007 10:01 PM CST

3 Stars Means It's Healthy, Right?

Experts fear that new health ratings systems may befuddle shoppers

(Newser) - Stars, numbers, and letter grades are coming to grocery stores near you, the New York Times reports—but experts fear that these health ratings may befuddle shoppers with conflicting information. Consumer advocates are studying three new food ranking systems, while the FDA, approached by a nutrition group, is soliciting ideas...

Salt May Get an FDA Shakedown
Salt May Get an FDA Shakedown
Nov 29, 2007 12:05 PM CST

Salt May Get an FDA Shakedown

Increased regs likely on concerns about overconsumption, health effects

(Newser) - As the White House readies a national campaign against obesity, the FDA today will consider whether to reclassify one of the biggest dietary concerns of all: salt. The American Medical Association says that for Americans, who each day consume around 2,000 milligrams more than recommended, cutting salt intake by...

Tamiflu Will Carry Stronger Warning Labels

Maker will beef up language on possible psychiatric side effects

(Newser) - The maker of flu drug Tamiflu said today it will accept recommendations by a government panel that it revise printed warnings about the medication's side effects. Labels already warn of possible psychiatric reactions, but the panel recommended noting that some people have died, the AP reports. Drugmaker Roche says flu...

Lack of Info Plagues Docs Treating Kids

Limited funding for research on meds puts children at risk

(Newser) - A dearth of information on the effects of prescription drugs on children is putting millions of kids at risk, the Washington Post reports. Two-thirds of the medications prescribed to kids haven't been tested on them, and those that have been tested often produce unexpected results: A migraine drug that works...

35.5 Million Americans Going Hungry
35.5 Million Americans Going Hungry
Nov 15, 2007 1:50 AM CST

35.5 Million Americans Going Hungry

Rising costs, stagnant wages threaten even worse news next year

(Newser) - US programs failed to make a dent in the number of Americans going hungry last year, and activists warned that rising costs and stagnant wages threaten to increase the army of citizens struggling to put food on the table. Nearly 13 percent of households—35.5 million Americans, with 12....

Diabetes Drug Given Strictest Warning Label

FDA's 'black box' adds risk of heart attack to concerns on Avandia

(Newser) - The FDA has applied its harshest warning to the diabetes drug Avandia, declaring the product potentially increases risk of heart attacks. Now marked with a “black box” warning, GlaxoSmithKline’s drug will stay on the market pending a continuing “safety assessment,” the Wall Street Journal reports; FDA...

White House Proposes New Import Safety Rules

Tougher rules, stiffer enforcement

(Newser) - The White House is set to roll out stiffer safety regulations governing imports today, reports the Wall Street Journal. The proposals, prompted by the wave of recalls this year, represent a move toward what the Journal calls "a prevention-based regulatory system that targets the riskiest products." The FDA...

Sales of Heart-Surgery Drug Halted
Sales of Heart-Surgery Drug Halted
Nov 5, 2007 9:35 PM CST

Sales of Heart-Surgery Drug Halted

Anti-bleeding med yanked after study shows higher death risk

(Newser) - Bayer Pharmaceuticals will suspend the sale of Trasylol, a drug used to control bleeding during heart bypass surgery, after a clinical study found that the drug puts patients at increased risk of death, the Washington Post reports. The FDA said sales of the drug would be halted at least until...

New Blood Thinner Tops Plavix in Trials

But prasugrel also adds risk of bleeding to death

(Newser) - An experimental new blood-thinner looks like real competition for top-selling anti-clotting drug Plavix, after proving more effective at preventing heart attacks, strokes, and heart-related death in a recent trial, the AP reports. But “there is a price to pay” for increased effectiveness, wrote one doctor—the new drug caused...

Budget Batters FDA Oversight of Foreign Drugs

Commissioner to testify before Congress today

(Newser) - The federal Food and Drug Administration's spotty record inspecting foreign drug manufacturers will be even worse next year as its budget drops just as developing countries are flooding the market with new medications, reports the Washington Post. Foreign drug plants are inspected only once every eight to 12 years because...

Chinese Drugs Go Unchecked
Chinese Drugs Go Unchecked
Oct 31, 2007 12:54 PM CDT

Chinese Drugs Go Unchecked

Loophole allows pharma-producing chemical companies to bypass regulation

(Newser) - China’s massive prescription drug industry has an equally massive flaw: pharmaceuticals made by chemical companies are not held to regulatory standards. Of nearly 500 Chinese companies at a recent drug trade show, 82 were unregulated and uncertified, the New York Times discovered. “This is definitely against the law,...

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