Only so much to say about this story.

It's about Senator David Vitter of Louisana.

He says that an FDA advisory committee's vote to revoke the approval of Roche-Genentech's Avastin for treating breast cancer is "essentially government rationing." The WSJ reports:

New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.

"I shudder at the thought of a government panel assigning a value to a day of a person's life," Vitter said in a statement. "It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough." In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee's vote appeared to be based on cost effectiveness, not safety issues.

"I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy," he wrote.

This is the same Senator who, as the WSJ reminds us, "slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn't be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency's website."

Summary:

• Scientists find no overall survival benefit and considerable side effects.

• Senator says the drug has proven track record of effective treatment and calls rejection "sickening...rationing."

Questions:

• Who knows better?

• Whose advice to trust?

(There, I've blogged about it without injecting my own opinion. Just the facts and some pertinent questions. Talk amongst yourselves. I'm verklempt.)

The New York Times had an important story that "highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. ...Those with the most to lose are the hundreds of thousands of people who receive an orthopedic device each year."

The Wall Street Journal Health Blog wrote that "The FDA is proposing new rules on consumer prescription drug ads aimed at making the information about side effects more understandable. (Off the top of our heads, we'd just suggest they slooooooowwww down when discussing all the rare, but often-horrific sounding side effects of a given medication.)... The comment period ends Monday (June 28)."

Blogger Brian Reid offered one more important followup about news coverage of the big American Society of Clinical Oncology meeting earlier this month. In so doing, he referenced George Carlin's 7 words, as I've been known to do. Excerpt:

"But during the meeting, the national media -- the New York Times, the Wall Street Journal, USA Today, the broadcast networks and the Associated Press -- wrote on only seven studies, a tiny snippet of what was presented. These seven stories, in turn, were pulled from the small number of studies promoted by the ASCO communications department with press briefings."

And, if you missed it, the New York Times reported that the University of Michigan did what its Big 10 counterpart Minnesota couldn't:

"In the latest effort to break up the often cozy relationship between doctors and the medical industry, the University of Michigan Medical School has become the first to decide that it will no longer take any money from drug and device makers to pay for coursework doctors need to renew their medical licenses."

A committee (on which I served) recommended to the Minnesota med school that it eliminate corporate funding of CME within 5 years, but that recommendation was rejected by the administration. Score one big one for the Wolverines over the gutless Gophers on this one.

While we recover from the news that flibanserin was unanimously rejected by a vote of an FDA advisory panel because the data didn't match some of the hyped claims, let's catch up on some stuff the FDA caught about the marketing of drugs it had already approved.

The Dow Jones Newswire reports:

"The U.S. Food and Drug Administration sent letters to several companies requesting that they stop distributing misleading promotional materials for their drugs.
...
The FDA said a 60-second television advertisement for Sepracor's Lunesta sleep aid makes "unsubstantiated superiority claims" in violation of federal law. A voice-over in the ad says viewers who have trouble sleeping even after taking a sleep aid should ask their doctors about switching to Lunesta because Lunesta is "different." The ad says Lunesta "keys into receptors that support sleep."
...
The FDA said this language misleadingly implies that Lunesta is clinically superior to other insomnia medications, and that Lunesta might work where others fail. The agency says it isn't aware of any evidence to support these claims. Also, the agency said the claim about how Lunesta works is misleading because there's still some uncertainty about the drug's mechanism of action.
...
In a separate letter to Eisai, the FDA said a promotional video for brain-tumor treatment Gliadel Wafer minimizes the risk of the drug and overstates its efficacy in violation of federal law. The drug's risks, which include seizures, are relegated to the end of the video after several cues suggesting the video is over, when it's unlikely to draw the viewer's attention, the FDA said.
...
The FDA said a Cumberland Pharmaceuticals sales aid for Acetadote, which is approved to prevent liver injury after an overdose of the pain drug acetaminophen, contains unsubstantiated superiority claims and minimizes risk information.
...
The agency's letter to Auxilium said a direct-to-consumer patient brochure for the drug Xiaflex, a treatment for a hand deformity, overstates the drug's efficacy and minimizes its risks."

These are stories most consumers probably don't see. They don't get much play in most news organizations. But they're little pieces that, when put together, are part of the huge mosaic of marketing muck that inundates American health care consumers every day.

The AP reports:

"...members of the Food and Drug Administration's reproductive drugs panel voted 11-0 that the drug's benefits did not outweigh side effects, including fatigue, depression and fainting spells.

Flibanserin failed to increase sexual desire, as recorded by women in daily journals, in two company studies.

The FDA will make its own decision on the drug in coming months, though it generally follows the panel's advise."

When will we learn to put evidence before hype?

To wait until all the evidence is in before promoting something as "the female viagra" - as "the pink pill" that women have been waiting for?

Shame on the journalists who hyped this story leading up to the FDA panel's vote. It resembled free advertising, free marketing, free buildup of demand for an unproven product.

And pity the poor consumers who heard about this every day and bought the hype.

When will we learn to be better evaluators of the evidence?

Addendum two hours after original post: many more good details in this story from MedPageToday.com.

The crescendo of news in anticipation of an FDA advisory committee's consideration of the drug flibanserin for hypoactive sexual desire disorder or HSDD is crazy.

And few stories question the oft-cited estimate that up to 40% of women may have this problem. Why don't they cite the source? Why don't they explain how flimsy the evidence is for that market-boosting projection?

NBC's chief medical editor, Dr. Nancy Snyderman, didn't challenge it in her nightly news story last night.

And while she did include a sound bite with a gynecologist skeptical about the drug, Dr. Nancy concluded:
"All eyes are on FDA on Friday as to whether women will have to continue to wait."

Well, let's slow down a bit. Not all eyes are unblinkingly fixated on their computer screens awaiting that FDA advisory panel's recommendation. First, their vote doesn't determine the FDA's final decision. So there will be at least one more wave of news about this drug. And many of the eyes that are so trained on the news have been whipped into a frenzy by the news itself.

But the phrase "whether women will have to continue to wait" is really loaded. How many are really waiting for a drug to improve their sex life? How many are tired of having yet another antidepressant prescribed for a "female problem"? Many alleged problems of women all end up in the same place: with an antidepressant prescription.

CNN.com published a story that didn't challenge a sexual medicine doc's statements that: "HSDD is a horrible tragedy in women" and that this drug would be "the beginning of an era" for women, and that having a safe and effective drugs is a "unique and historic opportunity for women in the U.S. and for the FDA."

Horrible tragedy?
Beginning of an era?
Unique and historic opportunity?

CNN didn't challenge any of those statements.

Let's step outside the realm of crazy American hype and peek at what Australian journalist Ray Moynihan wrote:

"In trials on women in the US, compared to placebo, flibanserin offered women an extra 0.7 "satisfying sexual events" per month. In the trials on European women, flibanserin simply failed to beat the dummy pill. With data like that, the drug is going to need all the marketing help it can get."

That's data, not drama. Journalism, not disease-mongering promotion of a drug.

Moynihan is co-author of a forthcoming book, "Sex, Lies and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction."

I predict: if and when the FDA rejects this drug, there will be many stories talking about how unfairly women are being treated and how this is rationing.

I, too, may then take an antidepressant. Consider the evidence.

Addendum: As another sign of how unquestioning some news organizations are, on Twitter, @MSNBC_health retweeted this:

RT @SexBrainBody: 3 times as many women are aware of erectile dysfunction (66%) than they are of female sexual dysfunction (20%) http://znl.me/BYH-Q6 #SXBB

FYI: @SexBrainBody, and the URL have "content developed with the support of a sponsorship from Boehringer Ingelheim Pharmaceuticals, Inc." - which is the maker of flibanserin. Gee, could the rest of us get free advertising from MSNBC that easily?

This week the FDA will vote on flibanserin, the much-talked-about drug for women with the condition called hypoactive sexual desire disorder or - because everything in sexual health needs an acronym like ED or PE - HSDD.

On the eve of the FDA vote, CBS last week ran still another story about flibanserin. This drug has received so much news coverage, you'd think it cures cancer.

And CBS did little more than promote the hype even more, saying FDA approval "could translate into a $2 billion market in this country alone" and then failing to challenge the disease-mongering estimate of "10 percent to 30 percent of women" with this condition. It all just goes along with the drug company's efforts to build a demand before the drug is even approved.

In fairness, the story did call it "a rather vague diagnosis" and did say that some "critics say creating a pharmaceutical solution is driven by greed. "

But then it flip flopped by offering only a single patient anecdote, a woman who didn't want to be identified, who was "desperate" after "losing her sex drive completely" and who now says she is "definitely improved" after being in a trial of the drug.

Meantime, this weekend I got an e-mail from a group calling itself "The New View Campaign" which opposes FDA approval of the drug. They've posted an online petition.

This group says the drug:

1. offers only TRIVIAL benefits to women's sexual lives, as shown in the company's clinical trials.
2. might have serious ADVERSE EFFECTS when marketed to a large population.
3. comes with an AGGRESSIVE MARKETING campaign to convince women that sexuality is located in the brain, and that low sexual desire suggests chemical imbalances in the brain.
4. contributes to UNDERMINING and CONCEALING social and cultural issues that lead to women's problems with sexual desire.
5. tends to pathologize normal sexual diversity and therefore NARROWS the 'cultural ideal' around female sexuality.
6. represents a classic case of the pursuit of PROFIT rather than women's sexual pleasure and scientific knowledge.

A few issues that CBS didn't touch on.

A few weeks ago, Medscape quoted Gail E. Wyatt, PhD, a sex therapist, psychologist, and professor in the Department of Psychiatry and Biobehavioral Sciences at the University of California, Los Angeles:

"There are sometimes good reasons why women have no sexual desire. They may be in a relationship that's unhealthy or where there's physical or sexual violence. ...This drug is not going to be a panacea for sexual problems, because often sexual problems are complex and happen for a good reason. My concern is that by prescribing patients a drug like flibanserin, we are medicalizing sexual function, rather than understanding the problem."

Finally, blogger Merrill Goozner writes:

"I have a much more prosaic concern. Because I write often about prescription drugs, I get inundated with email spam from robots selling male sexual dysfunction drugs (I don't want to use their names because it only adds to the volume). Approval of flibanserin will double that volume. So in the name of God, I beg the FDA committee: Stop spam! Vote no on flibanserin."

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."