Very important and very well done story by Richard Knox of NPR. It's enterprise reporting - not something he did in response to a news release coming across his desk. He evaluated evidence. He found troubling patient stories in young women - not the glowing, happy faces and balloons the drugmaker provides in ads and testimonials. He interviewed several expert sources.

This is a must read - you can read the text online.

Or a must-listen, which you can do here:

The Dow Jones Newswire carries a story that tells us:

"The U.S. Food and Drug Administration said Novartis AG's (NVS, NOVN.VX) use of a Facebook tool on the website for cancer drug Tasigna violated regulations by presenting misleading information about the drug.

The agency also said in letters posted on its website this week that Novartis used a misleading brochure for its blood-pressure drug Exforge, and that AstraZeneca PLC (AZN, AZN.LN) used misleading promotional material for the antipsychotic Seroquel.

The FDA said the U.S. website for Tasigna has a "Facebook Share widget," or a button that users can click on to generate Novartis-created information about the drug, which visitors can share with other Facebook users.

"The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," the FDA said in a July 29 letter to Novartis, which the agency posted on its Website Wednesday.

Drug companies have approached social media sites like Facebook and Twitter gingerly because the companies must comply with federal regulations requiring balanced presentation of risks and benefits for prescription drugs.

Tasigna is approved to treat a form of leukemia and is Novartis's follow-up to its blockbuster drug Gleevec. Tasigna is associated with serious risks including sudden death and liver-function abnormalities.
...
The FDA also took issue with Novartis's description of Tasigna as a "next-generation" treatment in some of the Facebook-shared content. The FDA said it has previously sent written advisory comments to Novartis about the misleading implications of the phrase "next-generation" when referring to Tasigna."

All that glitters is not gold.

Addendum on August 9: I missed this one from last week:

Dendreon Corp exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.

"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the U.S. Food and Drug Administration said in a letter to the company.

Some of Dendreon's promotions included a chart that "does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of" the company's main study, the FDA said.

Andrew Pollack's story, "Hope Against Hepatitis C," has many elements of solid health journalism - and from the business perspective as well.

Sure, it leads with "hope."

"The new drugs, which could start reaching the market as early as next year, could help subdue a virus that infects roughly four million Americans, most of them baby boomers, and 170 million people worldwide.

"I almost think this will be revolutionary, to be honest," said Dr. Fred Poordad, chief of hepatology at Cedars-Sinai Medical Center in Los Angeles. "We are chomping at the bit to try to treat as many patients as we can." "

But there is also frank discussion of reality - with some skepticism.

"But even if the drugs do work, some experts and doctors warn that this virus may be particularly tough to vanquish. Three-quarters of the people who are infected do not know it because they are not tested for the virus and because the infection can be asymptomatic for years while it stealthily attacks the liver.

And because this disease is transmitted by blood, those infected largely are former or current IV-drug users -- a population that characteristically has little or no health insurance -- who may not be the most able to stick to a lengthy treatment regimen that can cause brutal side effects.

Pharmaceutical companies "completely ignore the real face of hepatitis C," said Dr. Diana L. Sylvestre, who runs a clinic in Oakland, Calif., that treats drug addicts and former addicts with hepatitis C. "A minority of patients who have hepatitis C will benefit from these drugs."

When she gave a recent talk at Vertex, Dr. Sylvestre's first slide showed a man in a suit, meant to be a Vertex executive, with his head in the sand."

There was an inside look at pharma's promotional efforts.

"Nevertheless, pharmaceutical companies realize that difficulties getting patients screened and treated could limit the use of their drugs. So they are contributing to a groundswell of activism to raise awareness of what has long been known as a silent epidemic.
...
Drug makers contribute to the National Viral Hepatitis Roundtable, which helped pay for the Institute of Medicine report, and several companies have banded together into the Corporate Hepatitis Alliance to lobby for more government funding. In January, several companies started the Viral Hepatitis Action Coalition, to help finance research at the Centers for Disease Control and Prevention.

Vertex has commissioned studies projecting a rising toll from hepatitis C. One such study, done by Milliman, a health insurance consulting firm, projected that the number of people with advanced liver disease from hepatitis C would quadruple in 20 years if treatment did not improve.
...
"I think the companies have done a superb job of marketing this disease," said Dr. Ronald L. Koretz, emeritus professor of clinical medicine at the University of California, Los Angeles. Dr. Koretz said there was no good evidence that treatment made a difference since many patients cured by the drugs might never have developed serious problems anyway."

Enough excerpts and highlights. Read the entire story at the link above - or the old fashioned way - with newsprint in hand! My point is: more health business news should be as complete, balanced, indepth and analytical as this was.

Kudos to Pollack and the Times.

"Why Big Pharma should buy your doctor lunch sometimes" is the headline of an article on Slate.com that has upset many readers. I'm not terribly upset about it because it just seems too naive and misinformed to get upset about. The final line of the piece tells you all you need to know about the tone of the column:

"Ousting commercial support is creating a huge chasm in medical education, leaving doctors not only hungry but also starved for knowledge."

Some of the online comments posted in reaction to the piece:

• "This columnist is dangerously misinformed."
• "misleading"
• "this article really dropped the ball on any sort of reasonable defense."
• "Whoever wrote this must be a paid shill for the drug companies."
• "I wonder how many pharma paid lunches the author has had?"
• "This post has a naivete to it that is almost breathtaking."
• 'The manufacturer of Remicade has a huge financial incentive to advocate long-term use of Remicade, yet the author of this article doesn't see the inherent conflict of interest."
• (Physician:) "My experience has been that aside from providing info on new meds, what many salesmen (and a high percentage of stunningly attractive saleswomen) do is trash the competition's drug in an effort to get you to write for their own product. A lot of "new" meds being pushed are not really new but merely re-formulations or new combinations of old drugs designed to extend a soon-to-expire patent."
• "This article is both one-sided and under-researched."
• "I'm a bit disappointed about the one-sidedness of this article. First, I have to admit my biases. I am a physician who used to work in an academic medical center. While I was there, I wrote the policy banning pharmaceutical reps from bringing food and gifts to the medical residents, as well as tightening financial disclosure requirements for the faculty."

To a medical historian, especially one who tracks the pharmaceutical industry as Jeremy Greene of Harvard does, last week's Georgetown conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education (CME)" must have seemed like a flashback.

In his conference talk, Greene gave some of the history of concerns over such industry influence. He's also published on the topic. In this article, for example, he cited Pediatrics journal editor Charles D. May, who warned in 1961:

A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more "education" because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of "education."

And, while, Senator Chuck Grassley gets a lot of headlines today for his Senate Finance committee investigations into drug company influence on doctors and CME, we may forget the history of past Senate hearings on these issues.

From 1959-1962 Senator Estes Kefauver led historic hearings.

Then, as Greene writes, when there were implications of a firewall between the business and editorial functions of CME:

"...ample evidence of the porousness of these firewalls existed as early as 1976, sufficient to prompt a series of hearings into the subject led by Sen Gaylord Nelson (D, Wisconsin).
...
Despite such hearings, the influence of medical education and communication companies continued to increase throughout the 1970s and 1980s. By the early 1990s, the subject emerged again in another set of hearings--now chaired by Sen Edward Kennedy (D, Massachusetts)--provoked by increasing reports of extravagant marketing practices by the pharmaceutical industry."

He who ignores the past is doomed to repeat it.

In an interview, Greene said the '70s became a turning point.

In that clip, he used the term MEC - which stands for Medical Education Collaborative - which is an organization that provides continuing medical education.

Correction: Dr. Greene advises that it's actually MECC - for "Medical Education and Communication Company."

Consider these statistics:

There are more nurse practitioners (147,000) than there are family physicians (100,000) in the US.

These advance practice nurse professionals can write prescriptions, and it's estimated that the average nurse practitioner writes more than 6,000 a year.

And about 70-80% of those nurses who regularly attended lunch or dinner "continuing education" events sponsored by drug companies said they were more likely to prescribe the drugs that were highlighted in the lunch.

All of these statistics were presented at last week's Georgetown conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education?"

The presenter was nurse-researcher Elissa Ladd, PhD, RN, Asst. Clinical Professor, Massachusetts General Hospital Institute of Health Professions, who says the possible pharma influence on nurse-prescribers has largely flown "under the radar."

Georgetown's PharmedOut.org project, along with the Kennedy Institute of Ethics and the Georgetown University Law Center are hosting an academic conference, "Prescription for Conflict: Should Industry Fund CME?" tomorrow (Friday June 25, 2010). Speakers include Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA, Thomas Insel, MD, Director, National Institute of Mental Health, Daniel Carlat, MD, Carl Elliott, MD, Joel Lexchin, MD, Edmund Pellegrino, MD, and Paul Thacker, Senior Investigator, Office of Senator Chuck Grassley .

Maybe I'll see some of you there.

Conference materials are on the conference website.

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.

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."

Ads have led John Mack, of the Pharma Marketing Blog, to think that his chances are pretty good that he has ED and Low T. That's erectile dysfunction and low testosterone for those of you not up on pharma's alphabet soup of marketing.

Mack writes:

"Symptom quizzes designed by pharmaceutical marketers in cahoots with sponsored patient advocacy groups are dishonest, IMHO. I do not believe they represent "honest dialogues with the public" nor do I believe that they are in "the best interest of patient health," two principles recently espoused by Bob Perkins, Vice President, Public Policy, AstraZeneca. In fact, they are just the opposite: dishonest and in the best interest of the pharmaceutical company!"

But he also links to a hilarious post on male hormone replacement on the blog, "Is Something Not Quite Right With Stan." Excerpt:

"Big Pharma wants you to believe their aggressive promotion of 'T' disease is growing at epidemic proportions throughout America with millions upon millions of aging men being Low T ripe consumers for their much needed Testosterone-Gel treatment."

Meantime a story by Reuters Health says that Low T ointment ads have been running during the NBA playoffs. I must have missed those while focusing on double dribbles and three seconds in the paint. But Reuters reports:

"According to a review in the June issue of the Drug and Therapeutics Bulletin, testosterone replacement therapy is questionable because it has risks, its efficacy is uncertain, and there's no strong agreement about whether low testosterone is really a disease in older age.
...
"We're skeptical about this," Dr. Ike Iheanacho, the journal's editor, told Reuters Health. "You may have men who have symptoms who have low testosterone levels, but in our view it doesn't add up convincingly to an undoubted medical condition."

Reuters quotes another doc saying a European doctor "would look at you blankly" if you asked about Low T. Oh, those behind-the-times Europeans! Don't they wish they could do disease-mongering like we do in the good old USA.

On the NPR Health Blog, Scott Hensley reflects on news out of this week's American Society of Clinical Oncology meeting. Excerpts:

"The American Society of Clinical Oncology confab is the place to present the latest research on cancer treatments. But if you're hoping for breakthroughs, this doesn't look like the best year to attend.
...
But cancer keeps turning out to be more complex, as researchers tease apart the genetic characteristics that distinguish one variety from another. The differences make it hard to come with drugs that will help lots of people.

"Cancer is like cable television," Dr. George Sledge, a breast cancer specialist and ASCO president, told the Wall Street Journal. "Thirty years ago you had three channels. Now you have 500." "

He links to another good piece by Forbes' Robert Langreth on disappointments outweighing victories. Excerpts:

"The paucity of successful trials raises serious questions about whether big drug companies, in their efforts to replenish their empty pipelines, may be rushing too fast to push their targeted cancer drugs into large-scale trials before they understand the biology enough. It suggests that the success rate for novel cancer drugs remains dismal despite the big advances in basic science.
...
Memorial Sloan-Kettering colon cancer specialist Leonard Saltz says that despite all the hype and excitement about pricey new cancer drugs, in fact, by far the most important colon cancer drug remains a 50-year-old chemotherapy drug called 5-FU. No one has been able to find a better drug to replace it. "It is humbling and embarrassing," he admits. New drugs like Avastin and Erbitux "have added very modest benefits. They increase survival a few months, but they increase the cost of care tremendously."

In some cases, researchers don't know whether tremendously expensive new drugs keep people alive longer. In one of the big studies presented Sunday at the meeting, researchers revealed that ovarian cancer patients who got Roche's Avastin in addition to standard chemo lived 14 months before their tumors progressed, vs. 10 months for those who got standard therapy.

But to get this modest improvement, patients had to remain on the Avastin drug for 15 months, adding to the potential expense, hassle and side effects. So far, there is no statistically significant survival difference between the two groups; because most patients are alive it may be too early to measure this. "We may never know" whether it extends survival, admits lead researcher Robert Burger of the Fox Chase Cancer Center."

And, according to the New York Times, Avastin's cost - around $72,000 to slow the growth of ovarian tumors by about four months - raises questions:

"Many would not consider this cost effective for the gain seen," said Dr Elizabeth A. Eisenhauer of Canada's National Cancer Institute, in the Times.

Don't hold your breath. It's not going to happen.

Meantime, in one more way brand name drug makers promote their brand to doctors and patients - they are giving out $3 billion a year of their samples!

Katie Hobson on the Wall Street Journal HealthBlog writes:

To (roughly) put that in the larger context of pharma marketing, the (Congressional Budget Office) CBO reported last year that the drug industry spent "at least $20.5 billion" on other forms of marketing in 2008. Most of that, some $12 billion, not counting the cost of samples, went towards sales rep visits to doctors.

The CBO estimated that the industry also spent $4.7 billion on direct-to-consumer ads, $3.4 billion on event and meeting sponsorships and $400 million on advertising to docs, in journals.

An investigation by the BMJ and the Bureau of Investigative Journalism concludes that key scientists advising the World Health Organization on how to prepare for a flu pandemic had done paid work for drug companies that could benefit from these recommendations.

The report is summarized in the BMJ but a subscription is required.

In an accompanying editorial, BMJ editor Fiona Godlee writes that WHO's credibility has been badly damaged.

Excerpts of a BMJ news release:

WHO's advice led to governments around the world stockpiling billions of dollars of antiviral drugs as part of global pandemic preparedness plans. Yet these conflicts of interest have not been publicly disclosed by the WHO. Despite repeated requests, the WHO has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them.

This report echoes a highly critical inquiry by the Council of Europe, whose findings will also be published today (4 June), and will fuel suspicions that the drug industry was able to exert undue influence on the WHO's decisions about the swine flu pandemic and the mass stockpiling of drugs.

The investigation finds that the WHO's 2004 guidance on the use of antivirals in a pandemic was prepared by an influenza expert who had received payment from Roche, manufacturers of oseltamivir (Tamiflu), and GSK, manufacturers of zanamivir (Relenza), for lecturing and consultancy work. The guidance concluded that ... "countries should consider developing plans for ensuring the availability of antivirals" and that they "will need to stockpile in advance, given that current supplies are very limited."

In addition, the investigation found two other scientists who prepared annexes to the WHO 2004 pandemic guidelines had recent financial links to Roche.

According to Deborah Cohen of the BMJ and Philip Carter of The Bureau of Investigative Journalism, the WHO did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not clear whether these conflicts were notified privately by WHO to governments around the world, many of which followed its advice.

The WHO deny any industry influence on the scientific advice it received. It also says it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But the BMJ and the Bureau suggest that WHO seems not to have followed its own rules for the decision making around the pandemic.

And, despite repeated requests, the WHO has refused to provide any information about the conflict of interest declarations made to it, leaving the investigation to wonder "whether major public health organisations are able to manage the conflicts of interest that are inherent in medical science effectively."

Dr. Adriane Fugh-Berman of Georgetown is hosting the conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education?" While the primary audience is physicians, nurses, and other health care providers, she says the session will be of interest to diverse groups, including educators, regulators, policymakers, ethicists, consumer activists, and students.

See the conference agenda.

Register here.

Direct-to-consumer drug ads have drawn the scrutiny of federal regulators and some independent critics such as Consumer Reports. But the HealthySkepticism.org website and project has an AdWatch series that evaluates drug ads targeted at physicians in medical journals.

The latest is an evaluation of this ad for Pristiq for depression. You should read the whole thing, but here's an excerpt:

A superficial reading will mislead many people to the impression that the drug is an appropriate choice for major depressive disorder and perhaps wider indications. However, the advertisement does not provide any valid reasons for using this drug. As far as we are aware, there are no valid reasons for using this drug rather than other treatments when indicated. Since most health professionals are unlikely to give advertisements more than a superficial inspection, they are likely to be misled by this one.

The Journal of the American Medical Association this week published a commentary, "Psychiatrists' Relationships With Pharmaceutical Companies: Part of the Problem or Part of the Solution?" by the chief of the National Institute of Mental Health.

On his blog, psychiatrist Daniel Carlat praises the "power (and courage) of the country's chief psychiatrist calling his own profession out on the carpet for bad behavior."

But on the Health Care Renewal blog, Dr. Bernard Carroll, past chair of the Duke psychiatry department, writes:

"With ludicrous optimism and a series of straw man discussions, Dr. Insel (NIMH chief) makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced?"

Read the entire blog posts cited above to get a fuller flavor of the dispute.

As Reuters reports, "virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia (rosiglitazone) had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday."

The study appears in the BMJ.

Mayo's Dr. Victor Montori told Reuters:

"It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication. If you were to look at the proportion of people with favorable opinions, 94 percent of them had a relationship with a pharmaceutical company. If you were to look at the folks with an unfavorable opinion, 28 percent had a relationship with a pharmaceutical company."

Because the team found that a quarter of the scientific papers about Avandia did not disclose that the authors had financial relationships with the drug company, they wrote that the findings "underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted."

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."

Psychiatrist Daniel Carlat, on his terrific blog, raises questions - just as Senator Chuck Grassley is doing - about a WebMD TV commercial that leads viewers to take an online depression screening test. The test was funded by Eli Lilly--information that was apparently omitted from the TV commercial.

Carlat says the WebMD test takes the DSM-4 list of nine possible symptoms of depression, but adds a tenth:

"I'm having frequent headaches, stomach problems, muscle pain, or back problems.Yes or No"

Carlat believes that happens, as he writes:

"Because Lilly markets Cymbalta as the "go to" antidepressant for patients who have both depression and physical pain. This is not really a "depression screening test" at all. Instead, it is a "Cymbalta-requester" screening test.

WebMD is telling the public a big lie. The say that "this content is selected and controlled by WebMD's editorial staff" when in fact the crucial aches and pains questions was selected by Eli Lilly's marketing team to encourage patients to ask their doctors for Cymbalta."

In a Forbes column, Matthew Herper writes:

"When people talk about expensive drugs, they usually are referring to drugs like Lipitor for high cholesterol ($1,500 a year), Zyprexa for schizophrenia ($7,000 a year) or Avastin for cancer ($50,000 a year). But none of these medicines come close to making Forbes' exclusive survey of the most expensive medicines on the planet.

The nine drugs on our list all cost more than $200,000 a year for the average patient who takes them. Most of them treat rare genetic diseases that afflict fewer than 10,000 patients. For these diseases, there are few if any other treatments. So biotech companies can charge pretty much whatever they want."

Overactive bladder is one of the poster children for disease-mongering. Some have written that it's a "created new disease."

Others have analyzed that its prevalence has been over-estimated.

The folks at WorstPills.org (Best Pills, Worst Pills - a project of the Public Citizen's Health Research Group) write that there are huge questions about the drugs created to treat it:

"All of the drugs currently approved in the U.S. to treat overactive bladder work about the same. The results are all statistically significant, and they are better than nothing, but their effect is minimal (a reduction of about one urination per day compared to a placebo)."

They explain that the six drugs - yep, count 'em: six drugs for overactive bladder - are so-called anticholinergic agents.

"Unfortunately, these anticholinergic effects are both what makes them effective and what makes them potentially harmful. Although for patients with overactive bladder difficulty urinating is the intended effect of the drug, that same difficulty is, in a sense, a side effect of the drug. Taking more of the drug strengthens all of the side effects -- including both the desired effects, such as reduced urination, and the ones you do not want."

Hmm. Did you learn any of that in the TV drug ads?

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

John Mack, on his terrific Pharma Marketing Blog, gives us a pharma marketing perspective on the creation of an Omega-3 fatty acid prescription drug. Excerpt:

"The pharmaceutical industry is often criticized for developing new Rx drugs having little value over current medications. Such drugs are called 'me-too' drugs because of their similarity to existing Rx drugs. Glaxo has now taken this to a completely NEW level: developing an Rx drug that is a 'me-too' of existing over-the-counter dietary supplements. I am talking about LOVAZA, aka omega-3-acid esters approved by the FDA for the treatment of high triglycerides."

Mack goes on to do a cost and ingredient comparison, and explores what might be the clinical reality of the introduction of this new prescription drug. Read his entire blog entry.

Here's an ad for LOVAZA, which Mack cut out of this week's Newsweek Magazine:

Glad to see Naomi Freundlich on Maggie Mahar's Health Beat Blog address a column that the New York Times published last month, "Not All Drugs Are The Same."

Freundlich points out, appropriately, that:

"The "controversy" over generic drugs is really less than meets the eye. There have been scattered concerns--some based on patient or doctor reports, others from proprietary drug makers--about generics not being biologically close enough (bioequivalent) to name brand meds. But the issue is mired in complexity and misinformation. For example, many doctors accept significant payment from drug companies to promote their name brand drugs--especially cardiologists and psychiatrists. It can be hard to remain unbiased when a pharmaceutical company is paying the tab on research."

She quotes Aaron Kesselheim, an instructor in medicine at Harvard Medical School who has authored studies comparing generic and name-brand drugs saying the NYT column was "pretty irresponsible" because it doesn't reflect the body of evidence supporting the use of generics. "For the vast, vast, majority of pills and the vast, vast majority of patients there is no evidence of problems substituting generics for brand name drugs," he said.

I heard similar complaints about the column from Larry Sasich, consultant to the Public Citizen Health Research Group and co-author of "Worst Pills, Best Pills" --- and from Dr. Stephen Schondelmeyer of the University of Minnesota College of Pharmacy. Sasich wrote me: "The journalist covered the science but then used the experience of a patient and a physician as rebuttal to the evidence that there has been no credible evidence that generic drugs harm patients. This seems counter to good scientific journalism as uncontrolled observations were evidence that generics can cause harm." Schondelmeyer has told me for years that he continues to be perplexed by people who continue to breathe life into the "generics aren't safe or aren't equal" arguments.

NPR offers an in-depth look at the creation or re-definition of a disease and, as they call it, the "complicated biography of a medication" to treat it. Important story.

The New York Times published a couple of good articles that touched on the theme of disease-mongering this weekend.

One documented how drug companies sold hormone replacement therapy by making menopause into a disease.

The other showed how drug companies are turning premature ejaculation into a disease that requires treatment.

Disease-mongering for men and women. An equal opportunity marketing tactic. Find it in play in a drug ad near you.

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."

A Bloomberg story reminds us that 6 years ago journalist Ray Moynihan in the British Medical Journal called female sexual dysfunction (FSD) "the freshest, clearest example we have" of a disease created by pharmaceutical companies to make healthy people think they need medicine.

Now that the Boehringer Ingelheim drug company has announced results of a trial of its female libido drug, flibanserin, the disease-mongering is in full bloom again.

Some journalists injected some skepticism - like Susan Perry of MinnPost.com in her article:

"The bitter irony of the FSD controversy, says the Guardian's Ottery, is "the disempowering message that women who are having sexual problems are all ill."

For women, one of the primary causes of loss of sexual desire is "relationship issues," she says, "so feeling empowered to communicate what you want could be crucial in resolving this. Nevertheless, some women will want a magic bullet solution to their sex life problems. It is a tempting idea in our time-poor lives to pop a pill and not take the time to work out the root cause of issues and address them."

As I said, get ready for more annoying commercials."

And get ready for more annoying news stories. The Newark Star-Ledger bombed on the story, in our reviewers' opinions:

• No cost data was provided for flibanserin. But an estimate of the potential U.S. market, up to $100 million in sales, was given. Those sales estimates had to be based on some price assumptions. What where they? It doesn't seem that you should provide the one number without providing the other.
• This story misses the mark by failing to address the larger issue of whether acquired hypoactive sexual desire disorder in pre-menopausal women is a condition being promoted by pharmaceutical manufacturers to create a market for a new drug and to sell more drugs.
• This article cites very little medical or scientific evidence. The story should have noted that more reliable information would have come from more rigorous research published in peer-reviewed scientific journals.
• No adverse effects of the drug were reported in the story. Safety data reported indicates that potential side effects include dizziness, nausea, fatigue, somnolence, and insomnia.
• Most of the benefits reported in the story were described in general, lay terms: having more sex, wanting more sex and experiencing less distress related to lack of desire. The story should have placed any benefits in context and noted that while results were statistically significant the medical or individual significance appears to be quite small. For example, the story should have noted that women taking flibanserin had an average increase of 1.7 "sexually satisfying events" over the course of 6 months compared to an average increase of 1 event in women taking placebo.

Can local TV news do more than scratch the surface on important health news? My former student Jeff Baillon (There - the disclosure is out of the way) shows once again how well it can be done. He reported this week on the widely-prescribed proton pump inhibitor drugs for heartburn. But his angle was not one of breathless awe. Rather, he reported that "there's scientific evidence that these medicines might also cause the problem they're designed to cure."