Entries in Pharmaceuticals (5)


Pharma Claims Free Speech to Push Double-Duty Drugs

Comstock/Jupiterimages/Thinkstock(WASHINGTON) -- A patient who seeks medical help for overactive tear ducts shouldn’t be surprised if the doctor prescribes Botox, a drug typically reserved for removing facial frown lines.

Doctors often use this pharmaceutical strategy, called off-label prescribing, based on evidence that many drugs can do more than their narrow purposes approved by the U.S. Food and Drug Administration (FDA).

However, drug companies are legally barred from advertising the alternative uses, despite published or practice-based evidence that they work. The reason lies in decades-old restrictions by the FDA banning off-label promotion.

In the past, companies like Pfizer, Astra Zeneca and Eli Lilly have been fined billions of dollars for allegedly violating the FDA’s rules, and some salesman and manufacturers have been taken to court on criminal charges, reports the Wall Street Journal. Now, a few pharmaceutical giants are taking to the courts to change the FDA’s restrictions, claiming that the rules limit a drug company’s right to free speech in its advertising.

The FDA’s stance is simply that prescribing medications for unapproved uses puts patients at risk.

“FDA does not want pharmaceutical companies promoting something as safe and effective when that hasn’t been proven,” Thomas Abrams, director of the FDA’s Division of Drug Marketing, Advertising and Communications, told the Wall Street Journal. “Think of someone you love the most. Would you want that person on a drug that’s not proven simply because the drug was promoted in such a way?”

The drug companies’ motivations do make economical sense, said David Kroll, professor of pharmaceutical sciences at North Carolina Central University. It’s not always cost-effective for a drug company to undergo the FDA’s lengthy approval process for a second use for an already approved drug, particularly if evidence shows that the drug’s off-label use is safe and effective.

“The FDA is erring far more on the side of safety, and drug companies want the freedom to make as much revenue as possible,” Kroll said. “Probably the proper middle ground is if there’s published clinical data in a top quality peer-reviewed journal, there should be some allowance for advertising off-label uses.”

Many doctors use drugs that pull this kind of double duty. For instance, the erectile dysfunction drug, Viagra, can also increase blood flow to other parts of the body to help heal meningitis or avoid amputation. The drug known as Lumigan is an eye drop for glaucoma, but its twin Latisse is prescribed to help grow fuller, more luscious eyelashes. Even the illicit drug Ecstasy may hold promise for patients with post-traumatic stress disorder.

Copyright 2011 ABC News Radio


Drug Shortages Pave Way for Price 'Gougers'

Comstock/Thinkstock(DENVER) -- Ryan Stice, pharmacy director at Porter Adventist Hospital in Denver, says he gets inundated daily with phone calls, emails and faxes from pharmaceutical vendors who promise to provide drugs that are in short supply at his hospital. But there is a catch -- their prices are high, and their practices can seem questionable.

"I have a story about one of these vendors calling on a Friday night, lying to a staff member to get approval for shipment, and sending their products for Saturday delivery to avoid our normal safeguards on bogus shipments and invoicing," Stice said.

Operating in the semi-legal "gray market" of pharmaceuticals, this network of distributors works outside the normal drug supply chain, stockpiling vital drugs and offering to sell them to hospitals and clinics at inflated prices.

According to an analysis by Premier Healthcare Alliance, a national organization that collects and analyzes clinical and financial data from its member hospitals, recent unprecedented drug shortages have enlivened this "gray" pharmaceutical market.

The Food and Drug Administration currently lists 180 drugs that are in short supply around the nation, including drugs used to treat cancer and sedate patients for surgery and care. Mike Alkire, the chief operating officer at Premier Healthcare Alliance, which published data on drug price-grouging practices last week, said these shortages have left many hospitals scrambling for supplies of these vital medicines.

"When quantity decreased, demand increased, and so did the price," said Alkire.

Premier analyzed nearly 2,000 sales offers from "gray market" distributors and found an average price markup of 650 percent for drugs used to treat cancer and other critical illnesses, as well as sedate patients for surgery, that have been in short supply in recent months. The analysis found that 96 percent of the markups offered were at least double the normal price of the drugs. The highest markup was for the drug lebetalol, used to treat high blood pressure. Lebetalol usually sells for $25.90, but "gray market" offers priced it at $1,200.

Most hospitals don't buy drugs from "gray market" vendors, and inflated pricing isn't the only reason. These distributors often get their drugs from "quasi-legal sources," said Alkire, that may not store, ship and handle the drugs according to the manufacturer's standards. This decreases the safety and effectiveness of the drugs. Another worry is that "gray market" vendors sell drugs that are diluted or completely fake.

Some U.S. drug manufacturers try to keep their drugs off the "gray market." Debra Lynn Ross, a spokeswoman for drug manufacturer APP Pharmaceuticals, said the company only deals with authorized wholesalers and distributors. She said APP has started shipping drugs directly to hospitals and clinics to discourage stockpiling and reselling by gray-market vendors.

Hospitals have struggled to adjust to the drop in drug supplies. For some drugs, there may be equally effective alternatives that doctors can substitute in treatments. But other drugs have few options. Stice said when supplies of some drugs get too low, nurses and pharmacists mix drug doses in smaller sizes than usual, potentially decreasing waste when a medication is stopped early or changed.

Jeffrey Smerage, medical director of infusion at the University of Michigan Comprehensive Cancer Center, said doctors there have had to make hard choices about which patients get the most effective drugs. "None of those decisions are fair or easy, but we had few options," he said.

Premier recommends that hospitals and pharmacists take precautions in dealing with drug vendors, such as checking that the vendor is a licensed, authorized distributor of the drug, and to report suspect suppliers to authorities.

But Michigan's Smerage said the best way to deal with price-gouging vendors is to fix the dwindling supplies of drugs.

"In the end, you wouldn't have a gray market and you wouldn't have markups if there wasn't a drug shortage," he said.

Copyright 2011 ABC News Radio


Generic Drug Makers May Soon Pay for Inspection of Overseas Plants

Ryan McVay/Photodisc/Thinkstock(WASHINGTON) -- One of the world's largest generic drug makers is calling on its fellow manufacturers to help foot the bill for the U.S. Food and Drug Administration (FDA) to conduct inspections of overseas pharmaceutical plants.

Up to 40 percent of the drugs Americans use are imported, and around 80 percent of the active ingredients in those drugs are made in foreign facilities. The FDA only inspected 11 percent of the more than 3,700 foreign manufacturing sites in 2009, according to data from the U.S. Government Accountability Office (GAO). All manufacturing facilities in the United States, however, are subject to FDA inspection every two years.

In addition, the GAO determined the FDA does not have accurate information on all of the overseas facilities, meaning the agency could not keep track of where inspections were needed.

One infamous result of such oversight problems occurred in 2008, when Chinese manufacturers substituted a fake ingredient for the main one in a supply of the blood thinner heparin.  The contaminated drug killed 81 people in the United States and sickened hundreds of others.  The FDA never inspected the plants that manufactured the main ingredient.

Hoping to prevent similar situations from happening again, Mylan Pharmaceuticals is helping to negotiate an agreement between the FDA and generic drug makers that would provide $299 million a year for inspections.  That sum would come from fees paid by the manufacturers themselves.

The plan, which was first reported by The New York Times, was the brainchild of Mylan's president, Heather Bresch, who discovered that Mylan's foreign plants weren't held to the same quality and safety standards as the company's U.S.-based facilities.

"Every American has the right to know that whenever they go to have a prescription filled, it's held to the same standard of quality, whether it's made in the U.S. or overseas," Bresch told ABC News.

Bresch worked hard to win support for the plan from other generic drug makers.

"Generics account for 75 percent of prescription drug volume, and our industry was willing to step up," she said. "It's our chance to address issues of safety and standards."

Copyright 2011 ABC News Radio


More Older Women Ending Up in ERs Due to Suicide Attempts

Ryan McVay/Photodisc/Thinkstock(WASHINGTON) -- More and more women aged 50 and older are ending up in the ER after attempting to commit suicide with drugs, according to a new national report released Wednesday.

The Substance Abuse and Mental Health Services Administration, or SAMHSA, found that between 2005 and 2009, emergency room visits for drug-related suicide attempts by women in this age group jumped 49 percent -- from 11,235 visits in 2005 to 16,757 in 2009.

Despite the increase in these types of ER visits for women aged 50 and older, the report found that the number of visits by women of all ages remained fairly stable throughout the same time period.  However, SAMHSA did find a steep rise in visits involving specific prescription drugs, like pain killers, among all women.

The report said there was a 67 percent increase and a 210 percent increase in ER visits for suicide attempts involving two narcotic pain relievers, hydrocodone and oxycodone, respectively.

Futhermore, cases involving drugs used to treat anxiety and insomnia went up 56 percent throughout the four documented years.

Copyright 2011 ABC News Radio


Drugs and Supplements to US from China Mostly Unregulated

Photo Courtesy - Getty Images(WASHINGTON) -- A review from the Government Accounting Office found a growing percentage of drugs and supplements sold in the United States comes from China and is largely unregulated and uninspected by U.S. officials.

Critics say consumers have no way to know where their pills originate because federal labeling laws are not being enforced.  The Food and Drug Administration says its staff is too small to properly inspect all the plants producing medicines for the U.S. market.  In a recent review, the Kansas City Star found 80 percent of the ingredients and 40 percent of the finished pharmaceuticals sold in the U.S. were made overseas.  The government said half of them come from China and India.

Chinese manufacturers defended their safety rate, but critics pointed to a recent case in which Chinese-made Viagra, the erectile dysfunction drug, was found to have drywall components in it.  Other drugs made in China have been found to contain none of the active ingredients required.

Copyright 2010 ABC News Radio

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