An eight-month investigation by The Sun found that over the past five years some of Maryland's 46 nonprofit hospitals have received millions of surplus dollars from the payment system even as they sued tens of thousands of patients over unpaid bills. Many of these suits have been filed against patients in the poorest areas of the state.

With more than 132,000 cases filed against people in Maryland alone, and at least $100 million in judgements against hospital patients, its no wonder that medical care has become a top cause of bankruptcy.

While the numbers tell a story of national implications for our uncertain economy, the individual stories tell us of a debt collection bureaucracy with no oversight and little ethical constraint.

White had health insurance, but it didn't cover the bulk of her care. When bills started showing up about a month after her discharge, she signed up for the financial assistance program commonly called charity care.

A few months after her discharge, Hopkins sent her a ruling on her request for assistance that read, "Your responsibility is zero," according to court records. White said she rejoiced.

"I was saying, 'Oh gee, thank the Lord, because any time you have an operation like this, you know it's going to be a lot,'" she said.

But the bills kept coming. When her daughter asked why, the hospital said that charity care only covered one day's charges. Hopkins officials said it was possible for charity care to be approved for one day.

In January 2007, Bayview sued White in Baltimore City Circuit Court, stating in part that she "refuses to pay the amount due." That comment bothered White, who mailed a typed note to the court stressing that she "never refused to pay the bill," but simply didn't have the money to do so.

She said that she was "grateful" to the Hopkins surgeon who "saved my life" but that she and her husband, Charles, got by on $1,080 a month from Social Security and $152 in food stamps. "I have a little checking account that I pay my bills from. There is a little over $1,000 in that; so you see I'm in no position to pay all this money for the hospital bill," she wrote.

A month later, White asked the hospital again for financial aid, but was told the bills were "too old" to be eligible, according to hospital records.

The State of Maryland pays hospitals a charity care payment each year to make up for the bills that people can't pay themselves. But not every state has such a system, and it is likely that debt collection efforts are even more fierce elsewhere. One Maryland hospital reported that it will sue people who have a mortgage, while another reported suing people who have two cell phones and a savings account. Well, that could be any of us.

Take a look at the second part in the series here--where the Sun follows poor debtors through the legal process against a cadre of specialized law firms. Third part coming soon.

"Although it (health care reform) may not seem immediately relevant given our current difficulties," writes Peter Orszag in his blog post as Congressional Budget Office director, "it will be crucial to address the nation's looming fiscal gap – which is driven primarily by rising health care costs – as the economy eventually recovers from this current downturn."

Orszag’s right, most of us are still in shell-shock over the losses in our 401(k)s and our home values – an estimated $11 trillion, just vanished. And then there are the impending job layoffs. How is health care relevant to getting out of this economic hole?

It’s that fiscal gap he speaks about – we can’t keep paying more for less. If you’re fortunate enough to have insurance through your job, your premiums keep going up. The average for a family this year is $12,680, of which you pay about $3,350. That’s nearly double what you paid in 1999. Your salary didn’t increase that fast.

And then there are your deductibles. You now pay an average $1,000 a year if you’re in a PPO, according to the latest survey of employer-sponsored health plans. That, too, has doubled over just the past year. If you think all these cost increases don’t affect your employer, too, just ask GM.

More spending doesn’t mean better care. The Washington Post put it bluntly in dispelling health care’s biggest myths. The United States is No. 1 in only one sector of health care – spending. But we’re behind most developed countries on virtually every statistic for quality of care. That’s worth it.

As for those predicted layoffs, no job means no insurance. Try buying a policy on the open market. Consumer Reports found in a survey that three-quarters of people without insurance couldn't afford an individual plan. And if they could afford it, we found that the median out-of-pocket expenses for a year were $2,264; while those with employer-based coverage paid less, only $973.

Even if your job is secure, each lost job costs all of us more for healthcare. For every 1 percent rise in the nation's unemployment rate, another 1 million people will enroll in Medicaid (600,000 kids and 400,000 adults). The states have to come up with another $1.4 billion each time the unemployment rate ticks up to cover those health costs. How is your state dealing with its budget shortfalls? Higher taxes, more layoffs. The cycle continues.

This is a lot of numbers. Especially for the mathematically challenged like me. But consider this – if the new Administration makes quality health coverage that everyone can afford to buy part of our economic recovery plan, we will all have more money to pay for our mortgages, our college education, our retirement plans. And more important, we’ll have the peace of mind knowing that we have access to quality health care when we need it.

Isn’t that the real the goal of any economic recovery?

This FDA graph compares the number of reports submitted by consumers versus health care providers between 1998 and 2007. The growth rate of consumer reporting is nearly four times the growth rate for physicians and other health care providers! Pharma Marketing Blog provides a nice chart of the increase in report rate.

Could this growing trend of consumer reporting mean you are more aware of drug safety issues, as the FDA speculates? That may be true for some, but the majority of us still don’t know about the FDA’s reporting system.

Yet it seems that we hear of a new drug safety risk everyday. On Monday the FDA warned us of an increased risk of death associated with older antipsychotics such as thorazine and prolixin in off-label uses for seniors with dementia. The agency urged the drug manufacturer to issue a new black box warning label.

It’s great that we’re submitting more reports to the FDA’s MedWatch program than previously. But drug companies spend billions on direct-to-consumer ads that only tell you part of the story.

Under pressure from Washington, a few top drug makers have agreed to a six-month moratorium on some direct-to-consumer ads. This agreement places restrictions on ads for new drugs, not all ads that target us, and only for a limited time period.

The FDA commissioner recently sent a letter to Congress claiming it would take two years to study whether all drug ads on TV should include a toll-free number and website where consumers can report serious side effects to the agency. This, even though Congress required drug ads in magazines and newspapers carry the same reporting information, and told the FDA to study the TV proposal within six months.

I spoke out against this delay last week at the FDA’s Risk Communication Advisory Committee meeting, which is debating the issue and will make a recommendation to the agency. Those of us in support agreed that the more real-time information the FDA has about serious side effects, the more quickly it can evaluate the safety of drugs on the market.

The problem is, most people have no idea how to let the FDA know about the serious side effects they experience. I told the panel about Consumer Reports’ recent poll that found only 7 percent of Americans would report a side effect to the FDA. That same poll found that 87 percent thought it was a great idea to put the reporting information on TV ads.

I also told the committee about our petition signed by 56,000 of you in support of the effort (thanks again for your work).

It seemed most of the panel members agreed that two years is way too long for the FDA to decide this. A few expressed worry that having this information in TV ads would tie up the FDA’s phone lines with reports of minor side effects, though most supported the idea.

I think if anything, it's going to increase sensitivities to risk," said Christine M. Bruhn, a consumer food marketing specialist at the University of California, Davis. Bruhn also suggested the FDA consider using the number 1-800- SIDE EFT.

Kim Witczak, founder of the drug safety group WoodyMatters, also asked the committee to consider running Public Service Announcements (PSAs) while the study is in progress to inform consumers that they can report side effects to the FDA. Kim is the one who came up the idea of putting reporting information on drug ads in the first place. She knows how effective drug ads are – Kim has spent the better part of her career working in advertising.

In light of the FDA commissioner’s two-year study timetable, we need to keep the pressure up on the advisory committee. Please take a few moments to email your thoughts to the panel about why its so important the public knows how to report serious side effects.

Common sense – even for the FDA, two years is too long.

A January clinical trial of 720 patients found that Vytorin users didn’t benefit any more from their pricey, heavily-advertised drug than patients taking generic statins (Vytorin costs about $112 per month, while a generic statin costs $32 to $90 depending on the dosage). These studies challenge the traditional belief that lowering LDL (low-density lipoprotein i.e. “bad cholesterol”) means a reduced risk for heart attack.

Dr. Keith Aaronson from the University of Michigan admits he knew little about Zetia when he formerly prescribed it to high-risk patients: “The bottom line is that most of us, and I include myself, have been blindly bought into the idea that any drug that lowers LDL must be good,” he told Forbes.

Zetia may have been a perfect fit, given the climate of modern American medicine. A combo pill, Vytorin, doubled sales by combining it with the cheaper, generic Zocor. Almost no hard evidence supported its use. But it caused no annoying side effects, like a flushed face or achy muscles, which meant fewer patient complaints. Consumers came to the doctor’s office convinced by a stunningly effective ad campaign claiming that Zetia or Vytorin was right for them. Doctors, strapped for time by insurers, didn’t have the time to argue.

Merck and Schering first announced that their drug might not be all that back in January. After the companies issued their official statement, the FDA said it would review the data, expressing astonishment at the result. The FDA made no comment last week after the release of this additional analysis.

TNS Media Intelligence, as reported by Star Tribune, shows Merck and Schering-Plough spent about $472.8 million on advertising since the drugs hit the market, with about $5 billion in sales last year. According to GoozNews on March 31, this huge profit “is testimony to the power of marketing, and the poverty of medical and regulatory science.”

The day after cardiologists criticized Vytorin and Zetia, both stocks hit 12-year lows. Shering-Plough shares fell 26% and Merck shares fell 15%.

With Vytorin’s market potential suddenly shrinking, Merck has a new cholesterol drug on the way—Cordaptive. Merck expects to hear back from the FDA before July on whether it will approve Cordaptive. Heart patients deserve to know whether it works better than drugs already on the market before they start taking yet another high priced pill.

After weeks of vague answers, the FDA now says it has begun a study on whether TV prescription drug ads should carry a toll-free number and web address where consumers can complain about serious drug side effects.

This news came the same day Consumers Union held a press conference in the Capitol with members of Congress urging the agency put side-effect reporting information on TV drug ads. Pressuring the agency even more were the 56,000 signatures from consumers calling on the FDA to act.

The idea to put the 800-phone number on drug ads comes from activist Kim Witczak, who lost her husband, Woody, to an adverse drug reaction. Kim has spent the better part of her career in advertising; she knows firsthand the power TV ads have over consumers. “Drug ads are everywhere; shouldn’t giving people an easy way to report a problem with their medications be equally available?” she asks.

Rep. Jan Schakowsky took up Kim’s idea, and with other members, worked it into last fall’s FDA drug safety legislation. Print drug ads now must carry the reporting information; and FDA was to study the TV ad issue by March.

We checked with the agency and it appeared no study was underway, until Kim, Rep. Schakowsky, Rep. Rosa DeLauro and CU rolled out the petition signatures.

The pharmaceutical industry – surprise! – is officially mum on the issue, saying it is going to wait for the study before commenting.

But this is common sense: the FDA already has a toll-free number and Web address ready to take the information, called MedWatch (To report negative side effects to the FDA, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.)

The problem is, hardly anyone (a mere 7 percent) knows to report their side effects to the FDA, as a new Consumer Reports poll found. It’s vital that the FDA receives real-time side effect information – Most serious drug safety problems don’t show up until the product has been on the market for years and used by millions.

The easier it is for consumers to know how to report serious side effects, the more quickly the FDA can identify potentially dangerous drugs on the market. The government shouldn’t need another endless study to tell it that.

Everyday it seems like we may be getting closer to a Pharmageddon reality. On any given day you can read about some entity that’s challenging a drug company on their product’s safety. Pharmageddon reminds me of lines from singer Ani DiFranco’s “Decree”: Cancer, the great teacher / has been opening schools / downstream from every factory / still, everywhere fools / are squinting into microscopes / researching cells / trying to figure out a way / we can all live in hell.

Now here’s a thoughtful paragraph from Alan Cassels:

A key problem, which should be of keen interest to students of pharmageddon, is that the radiologist, unlike the truffle pig, can find any fungi with incredible precision but he has no way of knowing in advance if the discovery is a prized truffle or nothing worth salivating over. Also unlike the truffle pig’s hunting expedition which ends in a prize, the radiologist’s discovery is the beginning of the real hunt, stimulating biopsies, surgeries and other invasive examinations that often leave patients worse off, destroying much surrounding tissue and sometimes causing new cancers by the diagnostic tests themselves…

Somewhere between all the microscopes, chemicals, and flying butterflies, I hope we can think of some alternatives to Pharmageddon.

Although the babies are fine now, Quaid has sued heparin manufacturer Baxter and is considering a suit against the hospital: “Individually, nurses, doctors and pharmacists are good people. But they’re hamstrung by working in a broken system that’s obsessed with protecting its bottom line,” he said, as reported by the Health Blog.

Though some criticize Quaid for getting so much media hype, his family is certainly not the only one to experience the failures of our broken health care system. You can watch more stories here.

There are several kinds of preventable medical errors, some life-threatening. The Center for Disease Control reported last year that hospital-acquired infections account for nearly 100,000 deaths each year, or 4.5 hospital infections for every 100 patients. And the Institute of Medicine reported that medication errors harm 1.5 million people every year. With these alarming stats, it’s no surprise that many of us are dissatisfied with some aspects of our health care.

But hospitals aren’t doing enough to prevent risks and reduce patient suffering. That’s why 22 states have already passed laws that give their residents hospital infection rates. Find out if your state made the list!

Quaid is advocating for bar codes at patients’ bedsides to make sure patients are getting the right drug and dosage, while Tort Reform thinks you shouldn’t be allowed to question your doctor if something goes wrong: “You put your money in and you take your chances.” Do you have a better idea? Share it with the group!

Maybe not. Last month PLoS published a meta-analysis on antidepressants that found little difference between SSRIs (includes Prozac, Effexor, Serzone, and Paxil) and placebos except among very severely depressed patients, a response the researchers attribute to reduced placebo response rather than to the drug’s efficacy.

The researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective.

Unfortunately this PLoS study has received very limited U.S. media attention (not to ignore this), but I think the millions of people swallowing these medications would want to know if they’re actually backed by science and doctors should demand no less. This antidepressant-placebo debate has been going on for a while, and if anything, this study shows the need for continued oversight of these relatively new and powerful drugs.

In 2003, drug companies spent $3.2 billion on direct-to-consumer ads for antidepressants; ads which, according to Dr. Matthew Hollon from the University of Washington, Seattle, “provide a minimal amount of health information, describe the benefits in vague, qualitative terms, and rarely offer evidence to support claims.”

Some people found flaws in this meta-study, so feel free to share your opinion here.

In February 2008, the FDA issued draft guidance for the pharmaceutical industry when manufacturers give doctors medical journal articles that discuss off-label uses of FDA-approved drugs and medical devices. The agency says “okay,” as long as the articles came from peer-reviewed journals with expert editorial boards. The articles would contain a statement that the described off-label uses haven’t been cleared or approved by the FDA. They advise against distributing articles not supported by “credible medical evidence.”

Under the proposed rule, the agency will no longer require drug and device manufacturers to submit the studies to the agency beforehand or an intent to submit an application for FDA approval of the off-label use (i.e. perform clinical trials).

The FDA is accepting public comments on this issue until April, and you can go here for their contact information and reference number.

FDA officials said at a news conference yesterday that they had inspected the Chinese facility that provided the active ingredient to Baxter, although things are still unclear:

Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified.

And this inspection came a little too late:

The F.D.A. admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.

Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research admitted to Congresswoman Rosa DeLauro (D-CT) at a hearing Wednesday that the FDA only inspects about 10% of the foreign facilities shipping drugs and ingredients into the US.

We’re inundated by drug ads. The average TV viewer spends about 100 minutes watching drug ads for every minute spent in a doctor’s office.

We may be able to recite the beaver’s lines by heart, but most of us don’t know how to report drug side effects to the Food and Drug Administration, whose job it is to make sure medicines on the market are as safe as possible. The agency does little to educate us about Medwatch, the agency’s program for people to report side effects from their medications.

An Institute of Medicine report found that in 2004, only 21,500 of the 423,000 adverse event reports that year came directly from doctors and patients — even though there is an easy to use 1-800 number.
Drug safety activist Kim Witczak of Minneapolis, Minn. proposed a nifty idea: what if these ubiquitous drug ads included that 1-800 number? Rep Schakowsky of Illinois offered an amendment to the FDA reform bill last fall requiring this information for all drug ads. By the time the bill got to the President, it required drug companies to only include the 1-800 number on print ads, but not TV ads. Rather, the law called for FDA to study the TV ad idea.

Unlike the drug industry, we don’t want this idea to be swept under the rug. We filed a petition with the FDA to get this 1-800 number and a Web address included in TV ads.

Our goal -- to collect 50,000 signatures and deliver them to the FDA. If you like Kim’s idea — reporting drug side effects should be as easy as watching a TV drug ad — sign this petition and forward it to your friends and family.
Drugs are tested on only a few people for a limited period of time. Once marketed to millions, new safety problems often emerge.The easier it is for all of us to report side effects, the earlier the FDA will be able to detect safety hazards with medications and take action.

It’s simple: if consumers are going to continue to get bombarded by drug ads, then information on where they can report side effects should be just as available. We should demand nothing less.

I thought instead I’d look at the real voices in our health care system. Credit goes to the Consumer Health Quality Council for collecting stories and producing these videos.

Lisa, Linda, and Ginny remind us that our current health care system fails millions:

“I underwent multiple pain management treatments and took numerous drugs..the more they told me to give up, the harder I tried,” says Lisa of Boston who was misdiagnosed with Reflex Sympathetic Dystrophy.
“There were no beds available so [my mother] was left on a gurney for over 24 hours…it took a long time for the nurse to arrive to stop the bleeding on her right side..my mother was screaming from pain..in a few hours she was dead,” says Linda of Boston, whose mother died from preventable medical errors.
And Ginny of Boston says, “[Hospital-acquired] staph infection has not ruined my life but it will alter it forever.”

Presidential candidates have issued their health care proposals with lots of big media to cover them, but will the proposals help Lisa, Linda, and Ginny?

Hillary Clinton has a plan to improve health care quality by giving financial incentives to physicians who stay up on the latest medical advances and procedures. She also wants to invest $125 million improve standards for quality in doctors and hospitals. And she wants to make a “patient-friendly quality database” that will assist patients in comparing different health care delivery systems.

Barack Obama supports quality and efficiency by creating a national public program where participating insurance companies report data “to ensure that standards for quality, health information technology and administration are being met.” Obama, a little more specific about his “quality database,” will require hospitals and providers to publicly report health care costs and quality, including data on preventable medical errors, nurse staffing ratios, hospital-acquired infections, and disparities in care.

Finally, John McCain emphasizes saving money and wants to promote competition on the cost and quality of care. He doesn’t specify how he wants to reduce medical errors, but he doesn’t want Medicare paying for them. Instead, he will “require transparency by providers regarding medical outcomes, quality of care, costs, and prices.”

Based on their campaign websites, Hillary and Obama have more developed plans for addressing the quality of health care, whereas McCain gives government a more limited role.

These video stories and other stories like them reinforce the need for doctors, hospital administrators, current and future patients, and lawmakers to offer workable solutions. Do you have a story to share?