Citizens' Issues
What a failed Vegas sex pill and the Meningitis outbreak have in common

Drugs produced at 'compounding' pharmacies - like the steroids suspected of 12 meningitis deaths - are exempt from the safety checks that mass-produced pharmaceuticals receive

Imagine my surprise when I heard about Vegas Mixx, the latest club drug being promoted in Las Vegas. Marketing materials described it as a combination of Valium, to relax the mind, and Viagra, to stimulate the, well, you know. Vegas Mixx promised to make users perform “Like a Porn Star.”

I’m no medical expert, but this didn’t sound like a good idea. Valium, a controlled substance, can have serious side effects. And Viagra, well, warnings about erections lasting longer than four hours should give anyone pause.

Was it legal? When I was a reporter at the Las Vegas Sun, the guys running the local compounding pharmacy that made Vegas Mixx had no problem telling me they were just trying to make a buck. They claimed it was legal. And indeed, the pharmacy never was disciplined by the Nevada State Board of Pharmacy. They only stopped producing the drug because it wasn’t profitable.

Vegas Mixx turned out to be a bust. But it highlighted an evolution in the drug compounding industry, which has come under intense scrutiny after steroids produced by a Massachusetts company were linked to 12 fungal meningitis deaths and 137 infections in 10 states. The New England Compounding Center, which made the injectable steroids linked to the outbreak, acted more like a drug manufacturer than a traditional compounding pharmacy, said David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacies.


Compounding pharmacies typically provide custom-made drugs based on individual physician prescriptions tailored to specific patients, who, for example, might be allergic to a mass-produced product. In contrast, the compounding pharmacy that made Vegas Mixx was making and marketing a drug combo before a doctor had prescribed it. The New England Compounding Center shipped more than 17,000 doses of steroid injections to 23 states, according to the Centers for Disease Control.


Those steroid doses, and other concoctions by compounding pharmacies, are exempt from traditional review and approvalby the Food and Drug Administration, which is charged with assuring the efficacy, purity and safety of manufactured drug compounds and strict adherence to sanitary manufacturing standards.


An FDA official said in an email that state pharmacy boards are the front lines of enforcing the activities of compounding pharmacies. The FDA can step in, but there have been conflicting court rulings about how federal law applies to compounding pharmacies, the FDA official said. That means compounding pharmacies operating as manufacturers are below the radar of FDA oversight, Miller said, potentially putting patients at risk.

This could have been prevented. More than a decade ago, David Kessler, former FDA commissionerissued a warning about the future of compounded drugs at a Congressional hearing prior to passage of the Food and Drug Administration Modernization Act of 1997. He said that ambiguity in the law could allow for “large scale manufacturing under the guise of pharmacy compounding,” leading to a “shadow industry” of unapproved generic drugs.


Provisions in the act designed to clarify FDA oversight of compounding pharmacies — including restrictions on their ability to advertise drugs — were later struck down by courts. Still, the FDA says it can act in some circumstances, such as when a drug is contaminated or mislabeled.

Miller said he believes only a few rogue compounding pharmacies are operating outside traditional boundaries. The New England Compounding Center “appears to have been acting as a manufacturer without being registered as a manufacturer with the (Food and Drug Administration), or registering with the Massachusetts Board of Pharmacy as a manufacturer,” he said.

“Something does need to change. That’s something our association is grappling with right now,” he said. In the wake of the outbreak, officials from the academy are in contact with congressional staffers to discuss how to increase oversight without stifling traditional pharmacy practices, Miller added.

Other cases have raised alarms. In 2007, a Portland Tribune investigation revealed patient deaths that were linked to a bad batch of drugs, used to treat back pain, from a Texas compounding pharmacy. A pharmacist who consults with the advocacy group Public Citizen called the compounding pharmacy industry a “shadow drug industry,” in an interview with the newspaper.

And this week the Tennessee attorney general filed a complaint against HRC Medical Center, a hormone replacement therapy company that used a compounding pharmacy to produce the testosterone pellets for women. In the past year, I interviewed several women who were treated at HRC facilities, and they complained of testosterone treatments that led to excess facial hair, uncontrollable rage and genital growth. One doctor who reviewed an HRC patient’s medical records on behalf of ProPublica said her testosterone levels were more than four times normal – into the range of a man.

It's unknown whether the alleged problems at HRC Medical were caused by the providers, by the pharmacy, or both. Officials from HRC Medical did not return calls for comment. But according to the attorney general’s complaint, the hormone pellets the compounding pharmacy supplied to HRC Medical could trigger an unpredictable release of hormones in the blood stream due to their unproven method of manufacturing. The pharmacy's production standards, material handling practices and operating procedures were not FDA approved, the complaint stated.


Miller said responsibility for the fungal meningitis outbreak goes beyond the compounding pharmacy involved and regulatory gaps. Doctors and medical providers purchased the drugs and should also be held accountable for the patient harm, he said.

“What due diligence did those facilities do to assure the drugs they were purchasing were appropriate, safe and effective?” he asked.

Sagar Atre of ProPublica contributed reporting to this story. 




Suzlon bondholders reject more time to repay $221 million debt

Suzlon's FCCBs worth $221 million or Rs1,172 crore are maturing today. The wind turbine maker has a net debt of Rs11,165 crore at the end of March 2012

New Delhi: Wind turbine maker Suzlon Energy on Thursday said bondholders have rejected its proposal seeking four-month extension to repay debt of nearly $221 million, reports PTI.
The foreign currency convertible bonds (FCCBs) worth $220.8 million (about Rs1,172 crore) are maturing today.
"I regret to announce today that the bondholders' meetings did not achieve the consensus we were hoping for and the four-month extension sought by us has not been granted," Suzlon Group Chief Financial Officer Kirti Vagadia said in a statement.
Shares of the company slumped 3.63% to Rs15.95 in early trade on the BSE.
Suzlon had issued $200 million Zero Coupon Convertible Bonds and $20.8 million 7.5% Convertible Bond. The company on 18th September had sought extension for redeeming these bonds.
Noting that the company expects an acceptable solution at the earliest, Vagadia said, "We continue to enjoy the support and confidence of our secured lenders for our business objectives.
"We believe our ongoing engagement with them and our bondholders continues to be both constructive and progressive, and geared towards addressing our liabilities and our overall capital structure in a holistic manner."
In recent times, Suzlon has been grappling with rising debt and stiff competition in global markets.
Vagadia said, "Suzlon Group appreciates the loyalty of its customers, the support of its suppliers and the dedication of its employees through this process.
"In addition, with an order book in excess of $7.2 billion, we believe the business can and will stabilise and the Group's senior management is committed to restoring the company to a position of strength."
The company had redeemed FCCBs of $360.2 million in July this year.
Suzlon's net debt touched Rs11,165 crore at the end of March 2012.


Van Gogh sells Shriram City Union shares worth Rs190 crore

Van Gogh, which held 66.25 lakh shares in Shriram City Union has sold about 25 lakh shares at Rs771 per share

Mumbai: Van Gogh Ltd, one of the shareholders of Shriram City Union Finance, has offloaded about 25 lakh shares of the non-banking finance company (NBFC) for a little over Rs190 crore, reports PTI.


According to bulk data available with the stock exchanges, Van Gogh, which held 66.25 lakh shares or 12.64% stake in Shriram City Union Finance at the end of June quarter, today sold 24.69 lakh shares of the company.


The shares were sold on an average price of Rs771.03 valuing the deal at Rs190.36 crore.


Meanwhile, Vontobel Funds Inc acquired 24.46 lakh shares of the NBFC firm for Rs188.63 crore.


Last month, Van Gogh had sold substantial shares of Shriram City Union Finance through open market transactions on the stock exchanges.


Van Gogh offloaded 13.91 lakh shares and 22.89 lakh scrips of the the NBFC firm on 26th and 27th September, respectively.


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