The Midmorning Refill: Just when you thought it was safe to reach for the medicine cabinet

Today’s Flickr Photo

The U.S. Supreme Court for Sale. Flickr photo by takomabibelot.

 

If you read one thing today . . .

We already knew that pharma giant GlaxoSmithKline wasn’t above putting profits before patient health. There’s the case of its diabetes drug Avandia, the sale of which the FDA recently restricted. And now comes the disturbing news that the British drug maker knowingly sold contaminated baby ointment and an antidepressant that didn’t work. Glaxo will pay $750 million to settle criminal and civil complaints in this latest round of court cases, write Gardiner Harris and Duff Wilson in the New York Times. The case was sparked by complaints from Glaxo’s former quality manager, Cheryl D. Eckard, who told the FDA about serious problems at Glaxo’s premier manufacturing facility in Puerto Rico:

But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

Overheard:

By now you’ve probably seen the video from the Rand Paul for U.S. Senate campaign rally in Lexington, Ky. where Paul supporters wrestled a female MoveOn.org protestor to the ground and one man stepped on her head.  The guy who appears on video to be stomping 23-year-old Lauren Valle has told reporters that he wasn’t trying to hurt her. Rather, he was trying to hold her down for police and had to use his foot because a bad back prevents him from bending over. Valle told police she was assaulted while trying to take a photo with Paul while holding a fake “employee of the month” award:

“I think that this is an extreme example of the kinds of sentiments that people are feeling in many races across the country,” Valle said. “I think that tension is incredibly high.”

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FDA – cautious on food safety, reckless with prescription drug safety

The new guard at the Food and Drug Administration (FDA) has brought welcome, increased focus and action to protect people from unsafe or possibly unsafe foods. The most recent example is the massive recall recently of products containing hydrolyzed vegetable protein in which the FDA stated that although “no illnesses are known to be associated with this problem of [bacterial] contamination,” the agency was “taking steps to protect the public.”

Three cheers for that. New FDA Commissioner Peggy Hamburg and Principal Deputy Commissioner Joshua Sharfstein are rightly giving muscle to an agency that for too long has let industry call the shots.

However, in contrast to becoming more active in enhancing food safety by removing potentially dangerous products before they have caused harm, though, several FDA decisions in the past year regarding prescription drugs can only be described as reckless.

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Would you like some cheese with that whine?

We got a chuckle out of Henry I. Miller’s rant in Forbes today where he describes Public Citizen as “the rabidly antidrug, anti-industry, self-styled public-interest group.” The premise behind Miller’s commentary is that the Obama administration’s political appointments — and government regulation in general — are bad for business. Specifically, it’s getting harder and harder for the pharmaceutical industry to make a buck.

But excessive, erratic and highly risk-averse regulation has pushed development costs into the stratosphere, made approvals uncertain and slowed them to a trickle. As Fred Hassan, CEO of drug company Schering-Plough, said of the current regulatory climate: “What will it take to get new drugs approved? The point is, we don’t know.”

Miller

Excuse me while I wipe the foam from my mouth. Someone needs to clue these guys in on the fact that despite the “burden” of FDA regulation, the top pharmaceutical companies still rake in billions of dollars in profit each year. And while they complain about their research and development costs, the industry continues to spend almost twice as much money on marketing. Obviously, Miller and Hassan weren’t paying attention in 2009 when the FDA approved 26 new drugs, more than any of the previous four years.

But why should Miller, an anti-regulatory crusader and fellow at the conservative Hoover Institution, rely on facts when hyberbole will do?

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FDA should ban weight-loss drug linked to deaths

Four years ago, the Food and Drug Administration rejected Public Citizen’s petition to ban the weight-loss pill Meridia. At the time, the FDA said it wanted to wait to see the results of an ongoing trial. Well, those results are in and they show that Public Citizen’s concerns about Abbott Laboratories’ Meridia were well founded. Research from a 10,000-patient study shows that the popular weight-loss drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests and deaths in obese patients.

So, here we go again. Public Citizen filed another petition today asking the FDA for an immediate ban of Meridia. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the pressure is on the FDA to do the right thing:

If the FDA truly intends to operate as a public health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science. The FDA should therefore tell Abbott to pull Meridia from the market immediately.

When Public Citizen filed its first petition in 2002, it based its request on

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Living in a ‘Pharma Paradise’

Former Public Citizen research associate Jonas Hines and his medical school friends put together this video lampooning the pharma industry’s corrupting influence on doctors. It’s a great follow up to their earlier hit Still Just Some Guy (Not a Doctor Yet). While the video is fun, the message is serious. Big Pharma spends big bucks wooing doctors with cash, gifts, trips and other perks. In 2003, the pharma industry spent $25.3 billion on marketing to doctors. This is from Public Citizen’s 2007 testimony to a Senate committee:

Physicians typically claim that they are unaffected by such interactions (although they are willing to acknowledge that their colleagues might be influenced). But pharmaceutical companies would not be catering to the culinary and travel preferences of physicians if they thought their efforts were for nought. The evidence strongly suggests that the companies are right. For instance, contact with pharmaceutical company representatives is associated with changes in the prescribing practices of residents and physicians and more rapid adoption of new drugs by prescribers.

It’s encouraging that medical students recognize this problem and want to do something about it. Check out the American Medical Student Association’s Web Site, PharmFree to learn more about their campaign to bring accountability to the medical profession.

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Undue influence? Emory researcher hid pharma payments

flickr photo / Mike Licht, NotionsCapital.com

The latest stunner from Sen. Charles Grassley’s investigation into drug company payments to doctors and researchers involves one of the country’s leading psychiatrists, Emory University’s Charles B. Nemeroff. The NYT’s Gardiner Harris reports that Nemeroff failed to report at least $1.2 million in income he received from consulting contracts with drug makers between 2000 and 2007.

In doing so, Nemeroff violated Emory’s rules, as well as federal research guidelines, Gardiner writes. After the NYT story broke, Nemeroff “voluntarily” stepped down as chairman of Emory’s psychiatry department, at least temporarily. Gardiner writes:

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Catching up on the news we (sort of) missed

Between the financial meltdown, the on, off and on again presidential debates and the drama over the bailout negotiations, there were a few news items that got buried in the back pages (as if people still turned actual pages to get their news). The Wall Street Journal had a story about some allegations that, if true, offer an insight to how medical-device maker Medtronic gave doctors all sorts of inducements, including strip club visits, to gain their business.

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