Drugs and Medications News: December 2006 Archives

Animal studies 'of limited use'

lab mouse Tests of drugs on animals are not reliable in all cases, a study warns.

The British Medical Journal research looked at studies in six areas and found animal studies agreed with human trials in just three.

The high-profile London drug trial which left six men ill was carried out after animal studies showed the drug TGN1412 was effective.

This study, led by Professor Ian Roberts, suggests animal studies should be used, but not for all drug research.

FDANot all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to four companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.

These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.

New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.

Chinese factory closed over fake pill


chinaBEIJING—Chinese authorities have closed down a factory producing fake birth-control pills out of starch and glucose and arrested one person, media reports said today.

Tests by the Food and Drug Administration on the southern island of Hainan found not only that the pills were useless in preventing pregnancy but also contained toxic ingredients, the Beijing News said.

"The fake contraceptive medicines and abortion drugs have greatly harmed women's physical and mental health," it said, citing an expert.

Developing lifesaving drugs is anything but inexpensive

moneyThose already in Washington, and those newly elected to Congress, who want to artificially control drug prices got an important lesson in economics last week. They also got a tutorial on why new lifesaving drugs are so expensive.

The lesson came as Pfizer, a leading pharmaceutical maker, canceled trials of a new cholesterol-controlling drug — torcetrapib.

As the stock market opened on Monday, Pfizer's announcement over the weekend sent its stock tumbling 14 percent, kicking the stuffing out of the company's estimated worth by more than $20 billion.

Epidural babies can't get grip on what's breast


breast feedingWOMEN who give birth with the aid of pain-relieving epidurals find it harder to breastfeed than those who give birth naturally, an Australian study has found.

The research suggests some of the drugs used in epidurals make their way into babies' bloodstreams, subtly affecting their brains and development for weeks afterwards -- including making them less willing to breastfeed. The study by University of Sydney epidemiologist Siranda Torvaldsen adds to a growing body of knowledge that makes a link between the use of the pain-killing drug fentanyl in epidurals and problems with breastfeeding. During an epidural a catheter is inserted into the spine to allow the infusion of pain-killing drugs. These deaden the nerves that relay sensations of pain from the lower body.

GSK invest in miniature antibodies


GSKThe pharmaceutical giant has agreed to acquire Domantis for £230m (€340m). The UK based company have developed miniature antibodies that can overcome the restrictions in therapeutic applications commonly seen with larger biomolecules.

They achieved this miniaturisation by only producing the small part of the antibody or domain that actually binds to the target, disregarding the extra part of the protein. These domain fragments are up to 13 times smaller than normal antibodies (around 110 amino acids long).

Traditionally, pharmaceutical companies have concentrated on developing small molecule drugs. However, there is a growing trend towards developing so-called biopharmaceuticals: large molecules such as antibodies, vaccines and other therapeutic proteins. However, the increased size means that they have to be administered by injection or infusion, in contrast to orally administered small molecules.

Senate Approves Permanent FDA Chief


Andrew von EschenbachDec. 7, 2006 - The U.S. Senate voted 80-11 Thursday to back President' Bush's pick to lead the FDA.

The Senate's approval came after months of protests from Republicans and Democrats that blocked Andrew von Eschenbach, MD, from taking the politically sensitive office.

The agency has been without a permanent chief for nearly four and a half of the last six years. During that time the FDA has faced a range of perceived missteps that have increased lawmakers' appetite to reform the agency next year.

The Future of FDA


futureThe Food and Drug Administration celebrated its first century in 2006, but as 2007 begins, it is also stepping into the cross-hairs of a new Democratic Congress. Bolstered by a public that seems increasingly worried about the FDA's ability to protect it, the Congress is eager to leave its mark on the agency. "There is a confluence of legislation in the coming year," says Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs. "There are some big, must-pass bills, and that will create an environment where a lot of people will be proposing a lot of different ideas."

Key among the FDA reform bills will be legislation by Senators Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.) to give additional resources to the FDA's drug safety office and make it structurally independent of the agency's drug-approval division. This would remove conflicts of interest, a problem identified in several government studies but which the FDA denies exists. The Grassley-Dodd bill (S 930) also would give the agency more teeth to demand that manufacturers conduct postmarketing surveillance and other measures to track safety issues of newly approved drugs.

NIH scientist charged with conflict


briefcase with moneyWASHINGTON — Federal prosecutors on Monday charged a senior scientist at the National Institutes of Health with conflict of interest for taking $285,000 in fees from a drug company that was involved with his government research.

Dr. P. Trey Sunderland III is the first official in 14 years to be prosecuted for conflict of interest at the NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. Sunderland accepted the fees from 1998 to 2003 from Pfizer Inc.

Sunderland, who has headed the NIH's geriatric psychiatry branch, is scheduled to appear Friday in a federal courtroom in Baltimore, according to the office of U.S. Atty. Rod J. Rosenstein.

Nastech stands by its drug


nastech BOTHELL - Shares of Nastech Pharmaceutical Co. tumbled Tuesday after it revealed delays in developing a nasal spray for osteoporosis, resulting in the postponement of a $15 million payment from its drug partner.

Nastech's stock price fell $2.99, or nearly 16 percent, to close at $16.20.

In a conference call with investors, Nastech's chairman and chief executive said the hurdle doesn't quell the enthusiasm about the parathyroid hormone spray.

"We continue to be excited about the potential for PTH spray to be a safe and effective noninjectable treatment for osteoporosis," Steven Quay said.

U.N. health agency launches pharmaceutical review


UN GENEVA (Reuters) - The World Health Organization launched on Monday its first intergovernmental review of the pharmaceutical sector to try to find ways of making medicine more easily available to the world's poorest people.

In their five-day talks, the World Health Organization's 193 member countries are expected to look at how international patents limit access by keeping drug prices high, and to highlight areas now lacking investment, such as tropical and parasitic diseases.

A WHO commissioned report earlier this year drawn up by former Swiss President Ruth Dreifuss slammed the existing drug development, marketing and pricing system.

satireby Mike Adams

In a surprising move, the FDA has now banned the manufacture and use of vitamin D, citing studies that show vitamin D to be a powerful physiological substance that needs to undergo FDA approval before individuals are allowed to use it. Since sunlight exposure causes vitamin D production in the human body, individuals who intentionally expose themselves to sunlight will now be arrested and have their blood confiscated by federal health authorities. All citizens are advised to coat themselves with sunscreen every time they go out in the sun and avoid sun exposure until further notice.

Individuals caught seeking sunlight may be charged with not only possession, but trafficking of the vitamin D drug. DEA agents have been alerted and will be called in to arrest sunbathers. Sunscreen checkpoints will also be set up in public places where sunlight may occur, and any citizen who fails to test positive for the presence of sunscreen on their skin will be immediately arrested and charged with trafficking vitamin D.

Hat companies and sunscreen manufacturers hailed the FDA's decision.