Clipmarks | BobbyDelray's 'fda' clips

China Confirms It’s the Source of Heparin Contaminant

Thu, 20 Mar 2008 17:59:59 GMT

clipped by: BobbyDelray
clipper's remarks: We really need to address this issues with China. Is profit worth what we are doing to our children and now adult population?

Clip Source: blogs.wsj.com

China’s State Food and Drug Agency has confirmed that the contaminant in Baxter’s heparin was introduced in China, Bloomberg reports.

What’s more, the contaminant — called over-sulfated chondroitin sulfate — probably entered the drug pretty far up the supply chain. Scientific Protein Laboratories said the modified chondroitin was in the raw heparin they bought in China, then processed into the active pharmaceutical ingredient to sell to Baxter. The chondroitin probably didn’t come from pigs, and may have been used to meet production targets when more than 250,000 Chinese pigs were hit by a runaway infection, the Chicago Tribune reports. It wasn’t detected by SPL’s tests.

Chondroitin sulfate is “abundant and cheap,” according to an FDA official quoted by the WSJ. It typically comes from animal cartilage.

The modified chondroitin would clump together with real heparin in a way that would make the contaminant tough to spot in typical screening tests

Baxter’s heparin, now off the market

Tags: china, heparin, baxter, chondroitin

Billion Dollar Loogie

Mon, 10 Dec 2007 19:29:38 GMT

clipped by: BobbyDelray

Clip Source: blogs.wsj.com

Sure, the walking, talking gob of phlegm (pictured) was genius. But it was a clever intellectual property strategy that made that loogie worth $2.3 billion.

That’s how much British conglomerate Reckitt Benckiser just agreed to pay for Adams Respiratory Therapeutics, the maker of the cough medicine Mucinex (and sponsor of the Mr. Mucus ads).

Guaifenesin, the active ingredient in Mucinex, is a medicine that’s about as old as the hills. But Adams was the first company to do clinical trials to prove to the FDA that the long-acting form of the drug is safe and effective. That meant it got exclusive rights to that formulation — which was enough to get the FDA to bump a bunch of generic versions off the market. And congested consumers, happy to take their medicine less often, snapped up Mucinex.

Tags: mucinex, reckitt benckiser, mr. mucus, fda

Edwards Would Ban Consumer Drug Ads for 2 Years

Mon, 29 Oct 2007 19:36:35 GMT

clipped by: BobbyDelray
clipper's remarks: Good or bad idea? Would you miss those Viagra ads?

Clip Source: blogs.wsj.com

Add one more health-policy prescription to a presidential campaign that’s been full of health talk. John Edwards yesterday rolled out a plan to impose tighter rules on the direct-to-consumer drug ads that have played an increasingly important role in the drug industry’s marketing arsenal.

Under Edwards’s plan, a drug would have to be on the market for two years before it could be pitched directly to consumers. The plan would also require prior FDA approval of “major ad campaigns” and beef up rules about disclosing how well a drug stacks up against a placebo, according to Edwards’s Web site.

“You’ve seen these ads. You know who’s paying for them, right? You are,” Edwards said yesterday at a speech in New Hampshire, the AP reported. He added that the ads are “driving up demand for the most expensive and most profitable drugs.”

In the 2008 presidential race, the health-care sector has given $6.5 million to Democrats and $4.8 million to Republicans, the New York Times reports.

Tags: edwards, would, ban, consumer, drug, ads, for, 2, years

Lead in Lipstick, FDA to Investigate

Sat, 13 Oct 2007 17:54:55 GMT

clipped by: BobbyDelray

Clip Source: blogs.usatoday.com

A consumer group says that certain popular, U.S.-made red lipsticks contain "surprisingly high levels of lead" that might be potentially dangerous, and the Food and Drug Administration said it would investigate, while cautioning that previous claims "have not generally been supported" by FDA analysis, the Associated Press says.

The lead tests were conducted on 33 brand-name lipsticks by an independent laboratory last month on red lipsticks bought in Boston, San Francisco, Minneapolis and Hartford, Conn., according to the Campaign for Safe Cosmetics. The group, which advocates for toxic-free products, said that 61% had detectable levels of lead, and that one-third exceeded the FDA's lead limit of 0.1 ppm for candy. The FDA hasn't set a level for lipstick.

Here's the organization's press release and the full report.

Tags: lead, lipstick, fda, investigate, tests, campaign, safe, cosmetics

Cautious Optimism For New Alzheimer's Medications, Reports The Harvard Mental Health Letter

Sat, 13 Oct 2007 17:05:54 GMT

clipped by: BobbyDelray

Clip Source: www.medicalnewstoday.com

Alzheimer's disease takes a long time to develop, which suggests that it may be possible to design drugs that work early in the disease process, to delay the start of symptoms. Over the past decade, researchers have been testing a number of such "disease-modifying" drugs that target the earliest biological changes in Alzheimer's, reports the October 2007 issue of the Harvard Mental Health Letter.<BR><BR>None of the disease-modifying drugs now in development will cure Alzheimer's. But a number of them are currently in phase III clinical trials, the last stage before the FDA will consider approving the drugs for sale. Media interest has already begun to intensify. In June, for example, the AARP Bulletin trumpeted on its cover: "Finally, new drugs offer real hope for reversing the disease."<BR>

Tags: alzheimer's, harvard, medications, treatment

Medtronic Receives FDA Approval for Guardian® Real-Time Continuous Glucose Monitoring System

Thu, 11 Oct 2007 03:23:41 GMT

clipped by: BobbyDelray

Clip Source: wwwp.medtronic.com

MINNEAPOLIS — July 17, 2006 — Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardian® REAL-Time System, a doctor-prescribed continuous glucose monitoring (CGM) system for improved diabetes management. Especially well suited for diabetes patients who frequently monitor their glucose levels, the Guardian REAL-Time System is intended to help protect patients by alerting users to high and low glucose levels. The REAL-Time information and retrospective glucose trend data provided by the Guardian REAL-Time System are designed to help patients more tightly control glucose levels. Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including blindness, kidney failure, amputation, impotence, and heart disease. The system will be available nationwide by the end of this year.

Tags: medtronic, receives, fda, approval, guardian®, real-time, continuous, glucose, monitoring, system

Behind the counter drugs, No Prescription

Fri, 05 Oct 2007 20:09:33 GMT

clipped by: BobbyDelray

Clip Source: blogs.usatoday.com

The Food and Drug Administration may establish a new class of medicines known as "behind-the-counter drugs," according to the Los Angeles Times.

"It would let consumers purchase routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription -- as long as they discuss it with a pharmacist first," the paper reports. "Pharmacists and drug companies like the idea; doctors think it's dangerous. If approved, the drug classification could go into effect as early as next year."

Other countries already have such a process in place, which has been used in the USA with a drug known as the morning-after pill. FDA is scheduled to hold a hearing on the issue next month.

Tags: fda, behind the counter drugs, no prescription

Was $300 a month, now $4 a month

Fri, 28 Sep 2007 20:41:36 GMT

clipped by: BobbyDelray
clipper's remarks: Nice shiny toe nails for everyone. You get old the toe nails get narly, nevermore.

Clip Source: blogs.wsj.com

Digger, the repulsive cartoon character at left, has symbolized many things to many people. Today, Wal-Mart may have put the final nail in his coffin by adding the expensive drug he pitched to its list of $4 generics.

Digger sold Lamisil, Novartis’s pill for fungal toenail and fingernail infections. For Novartis, he represented the nastiness of a fungal infection under your nail. For the FDA, he showed that drug companies sometimes go too far in their ads. And some health plan officials saw the Digger ads and other Lamisil pitches as revealing the problem with direct-to-consumer drug advertising: They believed he drove consumers to ask their doctor for a pill they really didn’t need. And the treatment was expensive — more than $300 a month.

Tags: lamisil, cheap, walmart, novartis, fda

Lilly Can Finally Say Evista Reduces Breast Cancer Risk

Fri, 14 Sep 2007 21:13:30 GMT

clipped by: BobbyDelray

Clip Source: blogs.wsj.com

Way back in the ’90s, Eli Lilly was going around saying its osteoporosis drug Evista reduced the risk of breast cancer and cardiovascular problems, even though the drug hadn’t been approved for those uses. The company got in trouble for that ($36 million fine, guilty misdemeanor plea), but it turns out Lilly was half right.

The FDA has given the company the go-ahead to promote the drug to reduce the risk of breast cancer in some women, Lilly said today. As part of the deal, though, the company also had to add a black-box warning to the drug’s label, calling out its possible increased risk of blood clots in the veins and fatal strokes in certain women.

Tags: lily, fda, evista, fine, promote

More Drug Side Effects, or Just More Reports of Problems?

Tue, 11 Sep 2007 16:35:30 GMT

clipped by: BobbyDelray

Clip Source: blogs.wsj.com

Reports of serious injuries and deaths that may have been caused by prescription drugs skyrocketed between 1998 and 2005, says a paper published today in the Archives of Internal Medicine. But it’s unclear if the jump in reports to FDA reflects a true increase in the number of people who suffered serious side effects.

First, the numbers. In 1998, the FDA received 34,966 reports of serious adverse events, including 5,519 reports of deaths, possibly related to the use of prescription drugs. By 2005, those figures more than doubled, to 89,842 events including 15,107 deaths.

Tags: drug side effects, death, archives of internal medicine, fda, vioxx, institute for safe medication practices