In Medicine, New Isn’t Always Improved

Gerald · 06-26-11, 09:12 AM

IT is an American impulse to covet the new and improved — whether it’s a faster computer, a smarter cellphone or a more fuel-efficient car. And in medicine, too, new drugs, devices and procedures have advanced patient care.

But the promise of innovation can also prove a trap, a situation now playing out with dire consequences for possibly tens of thousands of people who received artificial hips intended to let them remain active.

The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear.

In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold.

http://www.nytimes.com/2011/06/26/he...me&ref=general

Note: Published: June 25, 2011

vienna · 06-27-11, 06:58 PM

Sometimes the FDA does actually act on behalf of the patient and not the mega-pharma corps; earlier this year, the FDA declined to enforce exclusivity for a brand-name drug over pharmacy compounded, generic versions. The issue was price. When the drug, progestin, was compounded by a pharmacy, the cost to the patient was around $15.00 USD per injection. A pharma-corporation, KV, who did not invent or patent the drug, bought exclusive rights to the brand-name version for $200 million USD. To recoup, they increased the price of the brand-name drug (Makena) to $1,500 USD per injection. The FDA then refused to enforce KV's exclusivity claims and allowed continued pharmacy-compounding of the drug. KV responded by lowering their price to a mere $590 USD per injection. AFIK, the non-enforcement of exclusivity continues. It should also be noted that the drug, progestin (or brand-name Makena) is a pregnancy assisting drug to treat pregnancy complications and the course of treatment would require many injections...

http://www.stltoday.com/business/loc...4ecd8c732.html

http://www.ipbrief.net/2011/06/01/a-...sivity-policy/

Sometime the actions of mega-pharm corps can be a bitter pill to swallow...

Gerald · 06-28-11, 12:10 AM

Quote:

Originally Posted by vienna

Sometimes the FDA does actually act on behalf of the patient and not the mega-pharma corps; earlier this year, the FDA declined to enforce exclusivity for a brand-name drug over pharmacy compounded, generic versions. The issue was price. When the drug, progestin, was compounded by a pharmacy, the cost to the patient was around $15.00 USD per injection. A pharma-corporation, KV, who did not ior patent the drug, bought exclusive rights to the brand-name version for $200 million USD. To recoup, they increased the price of the brand-name drug (Makena) to $1,500 USD per injection. The FDA then refused to enforce KV's exclusivity claims and allowed continued pharmacy-compounding of the drug. KV responded by lowering their price to a mere $590 USD per injection. AFIK, the non-enforcement of exclusivity continues. It should also be noted that the drug, progestin (or brand-name Makena) is a pregnancy assisting drug to treat pregnancy complications and the course of treatment would require many injections...

http://www.stltoday.com/business/loc...4ecd8c732.html

http://www.ipbrief.net/2011/06/01/a-...sivity-policy/

Sometime the actions of mega-pharm corps can be a bitter pill to swallow...

Interesting links that you have picked up,

06-26-11, 09:12 AM	#1
Gerald SUBSIM Newsman Join Date: May 2008 Location: Close to sea Posts: 24,254 Downloads: 553 Uploads: 0	In Medicine, New Isn’t Always Improved IT is an American impulse to covet the new and improved — whether it’s a faster computer, a smarter cellphone or a more fuel-efficient car. And in medicine, too, new drugs, devices and procedures have advanced patient care. But the promise of innovation can also prove a trap, a situation now playing out with dire consequences for possibly tens of thousands of people who received artificial hips intended to let them remain active. The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear. In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold. http://www.nytimes.com/2011/06/26/he...me&ref=general Note: Published: June 25, 2011 __________________ Nothing in life is to be feard,it is only to be understood. Marie Curie

06-27-11, 06:58 PM	#2
vienna Navy Seal Join Date: Jun 2005 Location: Anywhere but the here & now... Posts: 7,711 Downloads: 85 Uploads: 0	Sometimes the FDA does actually act on behalf of the patient and not the mega-pharma corps; earlier this year, the FDA declined to enforce exclusivity for a brand-name drug over pharmacy compounded, generic versions. The issue was price. When the drug, progestin, was compounded by a pharmacy, the cost to the patient was around $15.00 USD per injection. A pharma-corporation, KV, who did not invent or patent the drug, bought exclusive rights to the brand-name version for $200 million USD. To recoup, they increased the price of the brand-name drug (Makena) to $1,500 USD per injection. The FDA then refused to enforce KV's exclusivity claims and allowed continued pharmacy-compounding of the drug. KV responded by lowering their price to a mere $590 USD per injection. AFIK, the non-enforcement of exclusivity continues. It should also be noted that the drug, progestin (or brand-name Makena) is a pregnancy assisting drug to treat pregnancy complications and the course of treatment would require many injections... http://www.stltoday.com/business/loc...4ecd8c732.html http://www.ipbrief.net/2011/06/01/a-...sivity-policy/ Sometime the actions of mega-pharm corps can be a bitter pill to swallow... Last edited by vienna; 06-28-11 at 01:23 PM.