, April 28, 2011, New York – The FDA gives the nod to a machine that plucks bits of flesh off bald heads, helping doctors perform hair transplants. Is this better than Rogaine?

The image: The FDA has approved a device called the Artas System (see image below), which removes small pieces of skin from hairy parts of a balding man’s head, so they can be implanted in areas that need follicular assistance. As Tim Hornyak at CNET describes it, “the patient sits in the Artas chair, and his hair is cut to about 1 millimeter. A camera-equipped robotic arm under the control of a doctor then initiates ‘small dermal punches’ while harvesting individual follicles.” They are later manually transplanted, develop their own blood supply, and eventually grow their own hair. Artas’s function is one step in a process known as Follicular Unit Extraction, which avoids the sutures and bandages common to some hair-transplant procedures, like “strip harvesting.” As of now, the machine can only be used on patients with straight, brown or black hair — blonds and redheads need not apply.
The reaction: There’s “something about knowing that a robot arm will harvest your hair using ‘small dermal punches’ that’s a little bit unsettling,” says Graeme McMillan at TIME. “But to have a full head of hair for the first time in over a decade? I have to admit, I’d probably be okay with that.” Blond people are lucky in that they “still have a convenient excuse to not pay Artas a visit,” says Patrick Morgan at Discover Magazine. That is, “in addition to the whole ‘I’m not going near a flesh-harvesting robot’ thing.” See the Artas machine below:

FDA Panel Endorses Vertex Hepatitis C Drug



Chronic Hepatitis – Microscopic Photo. Chronic hepatitis C. Reticulin stain demonstrates bridging fibrosis with architectural distortion, no obvious cirrhosis (Stage 4). Reticulin Stain. Jian-Hua Qiao, MD, FCAP, Los Angeles, CA, USA (乔建华医师,病理学家)

,, April 28, 2011, WASHINGTON — Federal health experts say an experimental hepatitis C drug from Vertex Pharmaceuticals Inc. is a significant step forward in treating the virus, despite a high rate of rashes among patients taking the tablet.

The Food and Drug Administration’s panel of viral experts voted unanimously, 18-0, that the drug is a safe and effective treatment for hepatitis C. The agency generally follows the recommendations of its panels. A final decision is expected by May 23.

The most significant side effect with the drug was a sometimes severe rash in roughly half of patients.

The FDA convened a two-day meeting to review two new drugs that block the enzyme which allows the hepatitis virus to reproduce. On Wednesday the same panel unanimously recommended approval for Merck ( MRKnews people )’s drug boceprevir.




WASHINGTON – Federal health officials said Tuesday a highly anticipated hepatitis C drug from Vertex Pharmaceuticals successfully treats the majority of patients with the virus in less time than older medicines that have been used for 20 years.

The Food and Drug Administration posted its review of Vertex’s telaprevir ahead of a meeting Thursday where outside experts will vote on the benefits of the experimental drug. On Wednesday the experts will review a similar drug from Merck & Co. Inc.

Both new drugs work by blocking the enzyme protease, which allows the hepatitis virus to reproduce. The new approach represents a breakthrough from older medicines, which are designed to help boost the immune system to fight hepatitis.

Like HIV drugs, the new drugs will be prescribed as part of a cocktail with the two older drugs to help lower viral levels.

“A drug like telaprevir does an amazing job clearing the virus, but there’s a small portion that is just intrinsically less responsive and it’s the job of the older drugs to clear up that mess that’s left behind,” said Dr. Camilla Graham, Vertex’s vice president for global medical affairs.

The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.

FDA scientists said 79 percent of first-time hepatitis C patients taking telaprevir and the older medicines were cured, compared to 46 percent of those taking the older medications alone, according to Vertex’s studies. Among patients who had already been treated for hepatitis C once, 65 percent achieved a cure after taking telaprevir, compared with 17 percent of those taking the older medications.

In general, telaprevir’s cure rates are higher than those seen with Merck’s boceprevir. The two drugs are expected to compete in a multibillion dollar global market.

Shares of Vertex Pharmaceuticals Inc. rose $5.96, or 12.4 percent, to $54 in midday trading.

Vertex’s studies were designed to show that adding telaprevir to the older drug combination could cure most patients in six months — cutting the standard treatment time in half and reducing exposure to negative side effects.

According to the FDA, 58 percent of new patients were eligible for this shorter treatment regimen based on reduced viral levels after four or 12 weeks. The FDA’s review states that patients who have previously been treated for the disease should respond similarly.

FDA notes that the drug was significantly less effective for African Americans. The most common side effect with the drug was a skin rash and fatigue.

The agency will ask its panel to comment on those issues on Thursday. The FDA is not required to follow the advice of its panelists, though it usually does

Hepatitis C is a major cause of liver transplants, and it kills about 12,000 U.S. patients a year, a number expected to triple by 2030 as baby boomers succumb to the disease.

The disease is often associated with users of illegal injectable drugs like heroin, though it could also be picked up from blood transfusions before 1992, when testing of the blood supply began.

Most people with hepatitis C don’t even know they have the virus until years later when liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.

Vertex Pharmaceuticals is based in Cambridge, Mass., and was founded in 1989 by a former Merck scientist. If approved, telaprevir would be the company’s first commercialized product in the U.S. Vertex holds marketing rights for North America, while Johnson & Johnson will market the drug in other parts of the world.



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