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?

We’re in the age of “The Medicated Child,” (PBS’s new documentary) though the FDA has approved very few of these drugs for use in children. According to Dr. Patrick Bacon, a child psychiatrist, “It’s really to some extent an experiment, trying medications in these children of this age. It’s a gamble. And I tell parents there’s no way to know what’s going to work.” Parents propose many different explanations for the explosion in psychiatric prescription drug use.

In June 2006, the Archives of General Psychiatry found a fivefold increase in the use of drugs for children and adolescents with aggression and mood swings between 1993 and 2002. Experts told the NY Times the rise is partly because doctors are growing more comfortable with the newer generation of psychiatric drugs. That might be due to the secrecy shrouding many negative drug findings. Or the aggressive Pharma marketing to child psychiatrists.

Despite only a handful of small studies on antipsychotics in minors, the study found nearly one in five psychiatric visits for young people included a prescription for antipsychotics. And more than 40% of children on antipsychotics were taking at least one other psychiatric medication.

Said Dr. Julie Magno Zito, associate professor of pharmacy and medicine at the University of Maryland:

If you’re going to put children on three or four different drugs, now you’ve got a potpourri of target symptoms and side effects. How do you even know who the kid is anymore?

The study, Enhance, was released on January 14th and showed that Vytorin (a combination of the drugs Zetia and Zocor) does not work any better than Zocor alone in reducing fatty plaque in arteries. The investigation will examine the marketing of Vytorin and the sale of the companies' stocks to investors before the results were disclosed.

“We will investigate and, when appropriate, hold accountable drug companies for engaging in irresponsible and deceptive conduct and any deceitful marketing of prescription drugs," Cuomo said. "Drug companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients' health, and wasting taxpayer dollars, is simply unacceptable."

Although researchers finalized their conclusions in April 2006, the companies didn't make results public until two weeks ago. The companies blamed the complexity of the data as the reason for delay. They certainly enjoyed one last hoorah--the drug reaped in $5 billion in sales last year.

The closer you look at this controversy, the messier it gets. Members of Congress want to know why the companies sat on these results for almost two years. State Medicaid agencies, assuming improved results with Vytorin, paid millions for the drug during this time, and could have saved money buying equally effective, older medicines. New York alone paid a whopping $21 million just for this drug.

The companies also changed the “primary endpoint” of the trial (the result being measured to see if a treatment worked) after it was completed. This has left some doctors skeptical. ''This sounds highly unusual to me,'' said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. ''You need to live with your primary endpoint.''

Hopefully lawmakers will stay true to their word and fully investigate what’s happened here. In the meantime, we’re all waiting for the day when this kind of news will shock us.

Though PhRMA Deputy Vice President Alan Goldhammer said the study is outdated, the new report is actually the “most thorough to date” according to the New York Times, with 74 trials involving 12 drugs. “…[S]ince then we’ve put to rest the myth that companies have anything to hide,” said Goldhammer. The Consumerist posted this funny timeline, before and after.

Not good according to then New York Attorney General Eliot Spitzer. In fact, he filed a lawsuit against Paxil maker GlaxoSmithKline, saying they failed to demonstrate the drug’s effectiveness in treating children and adolescents. Safety and effectiveness should be an issue, since this report found that out of 38 “positive” trials, 37 were published, but only 14 of 36 “unconvincing” trials were.

The study’s lead author, Dr. Erick H. Turner, a psychiatrist and former FDA reviewer, said:

The bottom line for people considering an antidepressant, I think, is that they should be more circumspect about taking it, and not be so shocked if it doesn’t work the first time and think something’s wrong with them.

Added Dr. Jeffrey M. Drazen, The New England Journal editor in chief: “[Y]ou wouldn’t buy a stock if you only knew a third of the truth about it.”

The distribution of free samples has become very controversial. Evidence shows that free samples may influence physicians’ prescribing behavior and cause safety problems. For instance, we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy.

PhRMA’s Senior VP Ken Johnson called the study “fatally flawed,” saying that drug sample distribution “clearly benefits patients and advances healthcare throughout the United States.” This study shows that drug samples mostly reach the insured that have better access to medical care and have a better chance of buying these name-brand prescription drugs. But who is most in need? A 2005 study shows that uninsured adults are twice as likely as insured adults to say that they or a family member cut pills, did not fill a prescription, or skipped medical treatment in the past year because of cost. High drug costs can put a patient's health at risk. While they probably help some people, drug samples are like transparent band-aids unable to conceal our broken health care system.