That's how researchers Michael Hochman of USC and Danny McCormick of Harvard described medicine's lack of evidence for many treatments in an opinion piece in the Los Angeles Times that reflects on the authors' paper published in the Journal of the American Medical Association this week. Excerpt of the op-ed piece:

".. we analyzed 328 medication studies recently published in six top medical journals and found that just 32% were aimed at determining which available treatment is best. The rest were either aimed at bringing a new therapy to market or simply compared a medication with a placebo. Whether the therapy was better or worse than other treatments was simply not addressed.
...

Reform is also necessary to ensure that commercially funded research is designed in a way that is more helpful to doctors. Our study showed that two-thirds of commercially funded randomized trials compared medications with a placebo rather than with another active therapy. Though placebos are appropriate when no alternative therapies are available, in many of the trials we examined, we suspect alternative therapies could have been used instead. For this reason, we believe that regulatory agencies such as the Food and Drug Administration should only approve new therapies that have been shown to be at least as good as existing therapies whenever such alternatives exist. Alternatively, though more controversial, some experts have proposed that pharmaceutical companies should be allowed to fund -- but not design -- clinical studies."

Make sure you see the onslide slideshow accompanying this article about how the FDA is cracking down on drug companies for ads that underplay serious risks.

The slideshow gives you details on the ad or promotional campaign behind the drug and includes copies of the warning letters the FDA sent to the companies responsible for the false promotions. The FDA slaps are for things like omitting or minimizing side effects, implying that the drug could be used for something for which it hasn't been approved, or exaggerating effectiveness claims.

The ten products promoted in the ads are these:

• Latisse eyelash thickening drug - starring actress Brooke Shields
• Cymbalta - depression and pain drug
• Treximent - migraine
• hormone-releasing IUD Mirena
• Depakote ER for bipolar disorder
• Ertaczo - cream for foot fungus
• Fosrenol - kidney failure drug
• Visipaque - used in heart imaging procedures.
• Dacogen - for certain rare blood cell disorders and blood cancers.
• Kaletra - HIV drug - with ads featuring former NBA star Magic Johnson

Excerpt from the article:

"It's almost impossible for the public to actually parse the ads and come to their own independent conclusions," says Cleveland Clinic cardiologist Steven Nissen, a fierce critic of drug ads.

But Nissen is suspicious of most drugs that are advertised because he thinks that the marketing campaigns distract and mislead consumers. His advice: avoid the most heavily advertised drugs and stick to generics.

How can you avoid getting misled by drug ads? One way is to skip over the glowing patient testimonials and seek hard data about the medication's risks and how it performed in clinical trials. Every drug Web site also includes a link to the drug's official FDA label (the link usually says something like "Full Prescribing Information.") It's heavy reading, and many doctors don't even bother to do it. But it will have definitive, unvarnished information on how effective the drug was in its clinical trials and exactly what all the side effects were.

Great piece. Terrific online slideshow. I don't know how they limited themselves to just ten misleading drug ads.

NOMNATED FOR 2009 BEST MEDICAL BLOG

CBS News ran a segment last night on a little girl who apparently benefited from the use of a left ventricular assist device called "The Berlin Heart" - a device that supported her heart for a few days while she waited for a heart transplant. The girl was the daughter of Chicago Bears football player Charles Tillman.

Sanjay Gupta - on loan to CBS for this story from CNN - said the technology "saved her life." But no one can say that with any certainty. She was on the pump for a few days. No one can say if she would have survived those few days without the use of the device.

There was no mention of how much the device and its implantation cost. The cost of the device alone is $115,500, not counting the costs of hospitalization, surgery, etc. (Publisher's update of 12/16/09: This cost figure came from a document that was publicly available to anyone on the Berlin Heart corporate website on the day we posted this. The document has now apparently been removed from the Berlin Heart website, so we have removed the link that was once part of this story.) Pro football players are paid very well. How would others in the audience pay for the device or have access to it? These were questions the story didn't address.

Once the little girl went on the pump, did that automatically move her up higher on the transplant waiting list? If so, is that appropriate? And if so, how did the parents of other children on the waiting list feel about that? There was no discussion of the issue of how some people move up on transplant waiting lists, either.

The story did mention that the device is not approved by the FDA. Why not? The story didn't explain. It didn't explain whether the company had applied for approval and was rejected, whether it had applied but the FDA hadn't decided yet, or whether it simply hadn't applied yet. Regardless, there was no discussion of the evidence behind the device - and evidence is what matters.

Harold DeMonaco tracks innovation in medicine in his job as Director of the Innovation Support Center at the Massachusetts General Hospital. He's also one of our medical editors. He wrote to me:

"Unfortunately, in my view, the story strays from a purely human interest story to one that could be taken as a swipe at the FDA. I am particularly troubled by the statement, "Each time, doctors have to get permission from the FDA, and have it flown in from Germany." The obvious implication is that once again government is needlessly impeding delivery of vital care. But the story neglects to point out costs, that the Berlin Heart is not without problems, and that there is an alternative option (extracorporeal membrane oxygenation or ECMO) that has been used successfully for years and is a common approach in most academic medical centers."

So while this was a warm and touching human interest story, it did not educate viewers very well about the technology that the story claimed saved the girl's life, when, indeed, we don't know that. Stories about new medical technologies - even those with such an emotional personal anecdote - should deal with evidence, not hyperbole about one anecdote.

Indeed, another anecdote reported to the FDA tells quite a different story about the Berlin Heart. It describes another child who had the device implanted. Repeated problems with clots forming on the pump's outflow valve led to one, then two pump replacements. A crack developed in the device. The child had to have emergency resuscitation. Another crack developed, which led to bleeding and probable brain damage. The report concludes: "After a long discussion with the family, their wish was to withdraw further support, and to make the child's organs available for donation."

That's quite a different story than the one CBS chose to tell last night. The failure to scrutinize evidence - on harms as well as benefits - and to discuss costs and other options rendered the CBS piece incomplete and imbalanced.

The Wall Street Journal Health Blog published an interesting inside look of - as they put it - "how drug makers can try to lay the groundwork for sales well before a new therapy hits the market."

The topic is premature ejaculation.

Some might call the methods "disease-mongering."

The Minneapolis Star Tribune had a good idea in writing about possible changes in the FDA's medical device approval process.

I first blogged about this 3 months ago with a focus on the agency's 510K process - established 30 years ago as a way to allow the manufacturers of some medical devices to get a much easier path to approval if they can only show that their idea is "substantially equivalent" to something already approved by the FDA. That's a simplified view but you can read more at the blog link above.

Here's an excerpt from the Star Tribune story:

"...the agency's device unit is "clearly troubled." Of particular interest is the agency's 510k procedure -- a fast-track approval process for certain devices -- which is now under review by the prestigious Institute of Medicine -- a cause for some uneasiness in Minnesota, home to some 200 medical technology firms, including Medtronic Inc., the world's largest.

The Star Tribune asked Mark DuVal, a Minneapolis attorney and FDA expert, to discuss an agency in transition."

That attorney was the only source quoted in this Q & A story. That's a curiously one-sided journalistic decision. He's a lawyer who represents the device industry - presenting an obvious bias that wasn't balanced in the story. And so the story took on a "defend the homestate industries" tone that didn't deliver the whole story. This would have been a terrific opportunity for a point-counterpoint but no counterpoint was presented. And his views were predictably one-sided.

In order to get another view, I turned to one of our expert editors, Harold DeMonaco, who has a special interest in medical industry innovation in his position as the Director of the Innovation Support Center at the Massachusetts General Hospital.

DeMonaco wrote his reaction to me - outlining some of the problems with the current 510K procedure and with the story as it was presented.

"The existing process in some way thwarts innovation. By definition, the 510K approval is designated for substantial equivalence. That is, the device must do something in the same way as an existing device that was previously approved.

So, doing the same thing in the same way is somewhat equivalent to "innovation."

Innovation to an economist is the successful introduction of a NEW thing or method. Not merely a "me too" introduction. At issue then is the judgment call separating NEW from "me too." What is very desirable from the industry's standpoint is the introduction of something they can call NEW but under a "me too" process. Seems like a contradiction but I think that is exactly the sweet spot they shoot for.

His other comment that is interesting is his response to the safety question. He says the way to deal with risk is by putting it in the label. That may reduce the manufacturer's risk ("Hey we told you so.......) but not the patient's risk.

I think that the story could have legitimately examined the tension that exists in the judgment call around device approvals. The 510K process was designed to reduce unnecessary regulatory oversight. In a less complicated world this made a great deal of sense but as devices become more complicated, the decision process becomes more complicated as well."

And the story could have dealt with the complicated side better than it did.

Maybe they'll post a counterpoint to do so.

In the circles I run in, there's been a buzz about an announcement first made last December about a "partnership" between the FDA and WebMD. Yesterday the two entities announced an expansion of that partnership "to provide increased access to FDA's consumer health information."

I can appreciate the FDA's interest in reaching the public more directly with its messages.

But WebMD has turned over its "channel" - some of it marked "news" - to a government agency. Should journalists "partner" with a government agency for news and information?

And they boast that "Since the launch, over 150,000 consumers have accessed the FDA destination on WebMD ... The FDA's consumer information is also available through WebMD the Magazine, distributed ten times a year and reaching an additional 11 million consumers with each issue."

And I would remind the FDA that, while there may not be any ads on the FDA pages of the WebMD site, users are just a link away from ads on WebMD material. I just visited and quickly found myself viewing ads for drugs for fibromyalgia, depression, coronary artery disease and others. Is that appropriate for the FDA?

Something doesn't feel right about this - for either party - or for the public.

Sandy Szwarc of the Junkfood Science blog looked at this in greater detail when the partnership was first announced in December.

Front page. More than 2,000 words. The kind of story Americans need to understand. We're fortunate to have the WSJ on days like this with stories like this. - "FDA Backs Knee Device After Long Lobby Effort."

I've been tracking news coverage of a Minnesota company's heart "sock" device for heart failure for four years. Four years ago, I questioned Star Tribune coverage.

Two years ago, questions of evidence started to surface.

Today the Star Tribune reports:

"The high-profile consumer advocacy group Public Citizen expressed "deep concern" this week about whether the company's experimental device has been sufficiently reviewed by federal regulators. ...

Two advisory panels for the FDA have recommended against approval of the Acorn device after reviewing the company's application and holding public hearings. The agency itself has rejected the company's application three times. Acorn has even taken its case to a dispute resolution panel, a highly unusual move in the device world, which also voted against approval of its device.

Normally, a company in this situation would have abandoned the rather-expensive effort, especially a start-up like Acorn, which has no other products on the market.

But Acorn has been encouraged along the way by Dr. Daniel Schultz, a surgeon who is head of the FDA's device division, and the company subsequently reached an agreement with the agency to conduct a second, albeit smaller, clinical trial involving 50 patients. If that study is successful, the device could be approved by the agency without being first reviewed by an advisory committee and without a public hearing, according to Public Citizen.

In a Nov. 12 letter to Schultz, Public Citizen said the design of the new study "is so poor that it is unlikely to provide reliable data that would contradict the negative findings of the data so far submitted to the FDA." The number of patients enrolled in the study is too small, and they will not be followed for a sufficient amount of time, Lurie said."

I never would have picked up on the scent of this story had not the Star Tribune given such favorable coverage to the company and its product four years ago.

Gardiner Harris of the New York Times is all over issues about drug company influence on doctors and on the FDA this week. Today he writes:

Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.

Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A “significant number��? of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many.

Yesterday, Harris' story on "Doctors' Ties to Drug Makers Are Put on Close View" simply blew away the competition - better by far than any other story I saw on the subject in many media across the country - including right here in Minneapolis. He and Janet Robert reported on records in Minnesota, where drug makers are required to disclose payments to doctors.

The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify.

The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.

The reporting on this latter story was complete and comprehensive, with many examples of Minnesota physicians receiving surprising amounts of money from drug companies; ten doctors and one dentist received more than $500,000. You should read the entire story. But be ready to take an anti-anxiety pill when you're done.

Merrill Goozner suggests that the FDA announcement late last Friday afternoon, issuing an official warning against giving cancer patients erythropoietin drugs (Epogen, Procrit, Aranesp) for anemia, was timed to minimize bad news or embarrassment. Goozner writes:

"What struck me most about yesterday's announcement was its timing. It has long been a hallmark of White House public relations staff that the best time to release bad news was late on Friday afternoons. That way, the least number of people will hear about it through traditional news media sources. It's too late to make the Friday evening newscasts; and the print stories usually wind up inside the Saturday papers, which are the least read of the week. (The New York Times story, at least, got mentioned on the front page.)

This late Friday afternoon release shows as much as anything how the culture of the agency has been transformed in recent years from industry watchdog to industry lapdog."