DTC? Mais non. ItP.

05/27/2008 05:39 PM |

In our post-SiCKO environment, as Americans look to Europe to see how the other side of the pond is faring in 21st century health care policy, it's important to know the facts.

To that end, CMPI (the public policy home of drugwonks.com) is pleased to offer a new omnibus overview of what the EU refers to as "Information to Patients" (ItP) -- "Who wants to know?"

"Who wants to know" is written by CMPI senior fellow Jacob Arfwedson.  He's the chief of our Paris bureau.  A Swede who speaks French and German and writes in English.

And he's controversial in any (and every) language. 

To access "Who wants to know," go to  www.cmpi.org and look under "research papers."
  Read More & Comment...

1-800-RISKCOM

05/27/2008 05:37 PM |

Day Two of the FDA's Risk Communications Advisory Committee was (at least in theory) to focus on Section 906 of FDAAA that requires the FDA to study and produce a report on whether or not an 800 number in DTC television ads would distract from risk information presented via current fair balance and adequate provision practices.

"In theory," because the meeting did address this issue -- but the majority of the time was spent discussing other things.

First up was supposed to be Kit Aikin to present the FDA's proposed study protocol -- but she was feeling under the weather and was replaced by the very capable (and very pregnant) Amy O'Donoghue.

Amy discussed the FDA's proposed research experiment (sampling, design, proposed stimuli, etc.) and the always fascinating Federal Paperwork Reduction Act. The latter because she needed to remind the committee about our fourth branch of government -- the Office of Management and Budget -- and how OMB regulations impact the general timing of the FDA rule-making process.

(When asked how long it could take to complete the rule making process, Kristin Davis of DDMAC commented, "You're looking at a couple of years." And this is after the 24 months the FDA has to complete the research study.  One committee member was incensed and commented that Congress' intent was probably to delay the issue indefinitely and that something should be done about this OMB thing.)

BTW -- all the presentations, including the research protocol slides, can be found at www.regulations.gov. (reference docket FDA-2008-N-0226).

Some of the issues that came up:

* The use of the terms "adverse event" and "side effect" being used inter-changeably.  Just what do consumers think they mean?  The committee seemed to think that the FDA should look into this. 

* How can poly-pharmacy patients report an adverse event when they can't be sure what's caused it? 

* Will an 800 number (presented via a super, audio, or both) cause a "power of suggestion" situation, thus producing a kind of adverse event "placebo effect."

These general themes led the committee to worry  (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility.  A serious "signal-to-noise" issue. Of particular worry was how the FDA would then use this information relative to communicating "early safety signals."  Talk about unintended consequences!

* Speaking of FDA's use of information, it came out that DDMAC isn't looking at MEDWATCH reporting data. Explantation: they don't have the staff time to do the extra work.  Bad excuse. Seemed to me, based on the response of the agency folks present, that this isn't something DDMAC's ever even thought about.

* Per how to best present an 800 number, there was general committee consensus that it would require both a super as well as audio.  The "super-only" concept was shot down by one panelist who commented that "people aren't going to have pens and paper at the ready to copy down a number."

(Note to pharma physician detailers -- maybe a new use for pens.)

One committee member even suggested a "CNN-like crawl" that might run continuously during TV ads. (So now we're going to make risk information less distracting by making DTC ads more distracting?)

* Much discussion as well on how a regularly communicated 800 number would advance "the FDA brand" -- by showing that the agency is taking the lead not only in drug safety, but in safe use of medicines. Committee Chair Fischhoff commented that "the better the FDA brand, the better the industry brand." 

Amen.

The concept of an FDA public service announcement on reporting adverse events/side effects was discussed at great length -- as well as how the agency might pay for production and get media placement.  And there were a lot of "creative" ideas about the PSA. At this point, lots of people in the audience began picking at their blackberries.

* Much time also spent discussing the need to educate the American public that all drugs have both risks as well as benefits.

Where have I heard that before?

Here's the brief Reuters report of Day Two:

www.reuters.com/article/healthNews/idUSN1641693720080516

My favorite comment came from a note handed to me during the meeting that said,  "Hmm, a 1-800 number for ED ads?  I thought those would be 1-900 lines and cost $3.99 a minute."

As always -- where some see a problem others see opportunity.  Read More & Comment...

Pet Scans In Canada.. No Waiting

05/27/2008 05:35 PM |

www.macleans.ca/science/health/article.jsp  Read More & Comment...

The other kind of open public comment

05/27/2008 05:31 PM |

Speaking of DTC, here's what I had to share with Mike Schneider on Bloomberg TV:

vimeo.com/1020779

Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely.

(And the latter is more intimidating.)




  Read More & Comment...

RiskComm Mission Creep

05/27/2008 05:30 PM |

The second half of Day One was all about what the FDA is doing to help spread the message of safety/efficacy -- with a particular focus on the issue of "safe use" of drugs.

Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).

They all presented their terrific work.  All the more so considering the shoe-string budgets under which they operate.

But what does any of this have to do with DTC and under-served communities?

Let's just say it's tangential.

But (and not surprisingly) it really caught the attention of the committee.  Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.

Danger, Will Robinson, danger.

Day One closed with "Committee Discussion."  Some nutty. Some really useful.

Some examples:

* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.

* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA").  Good idea.

* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.

Yes, industry.

A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.

* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced."  And my other favorite, that DDMAC should pre-review "media placements."

At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.

Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.



  Read More & Comment...

T.S. Eliot and DTC Advertising

05/27/2008 05:29 PM |

To spice up my testimony, I enlisted help from Samuel Johnson,  Juvenal, Woody Allen , and W. Edwards Deming.

In closing, I urged the committee to ponder this question posed by T.S. Eliot:

"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?

Is anybody listening?  Read More & Comment...

What we need is ... more research

05/27/2008 05:27 PM |

Andreas Lord, of Eastern Research Group, presented a lit search of studies done relative to DTC issues and the "under-served" populations discussed in FDAAA.

Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."

The recommendations of the committee -- more research.

Very helpful.

This hearing is beginning to be like treading water in treacle.  Read More & Comment...

More from RiskComm II

05/27/2008 05:26 PM |

Only two people offered public comment.  One was a woman talking about advertising for atypical antipsychotics.  The other was me. The buzz among the press corps was "where's pharma?" 

Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket).  He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."

I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.


  Read More & Comment...

Bridges To Patients

05/27/2008 05:22 PM |

Very pleased to announce the launch of "The Patient," the new benchmark journal for peer-reviewed authoritative and practical articles on the application of pharmacoeconomics and quality-of-life assessment to optimum drug therapy and health outcomes.

According to the publisher (Wolters Kluwer Health), The Patient is "an invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization."

Here's a link to the magazine's website

John Bridges (Johns Hopkins School of Public Health and Senior Fellow, Center for Medicine in the Public Interest) is the journal's lead editor.

(And, in the interest of full disclosure, I am on the editorial board.)

Here is a link to the magazine's website: http://thepatient.adisonline.com

We welcome this important new voice to the debate.

  Read More & Comment...

HMO Profits Fall..A New Business Model in Order?

05/27/2008 05:12 PM |

Raising premiums and squeezing providers...that will just put HMOs on the political hot seat again.   Ultimately the health care decisions and dollars will have to flow doctors and patients and the real solution will be found in technologies based on underlying mechanisms of disease..

washingtontimes.com/apps/pbcs.dll/article  Read More & Comment...

The devil is in the details – not the detailers

05/16/2008 09:00 PM |

A few members of the New York State Assembly, led by Assemblyman Gottfried, the Chairman of the Assembly’s Health Committee, have introduced a bill that would require pharmaceutical detailers to obtain state licenses and abide by some peculiar rules.

For example: The bill would "establish a code of ethics for the practice of pharmaceutical detailing and collect information from registered pharmaceutical detailers relating to their communication with health care professionals, health care providers, or employees, agents or representatives of health care professionals or health care providers located in the state.”

What about the existing, rather stringent, government and industry regulations? Is the state going to legislate a floor or a ceiling? And as far as “collecting information,” that’s a pretty strong dose of Big Brother if you ask me and begs the question, “Whose next?”

The bill states that, “A pharmaceutical detailer shall not: engage in any deceptive or misleading marketing of a pharmaceutical product … For purposes of this section, it shall be considered an act of deceptive or misleading marketing to provide information regarding a use of a pharmaceutical product not approved by the federal food and drug administration.”

Even though the actual verbiage makes it sound as if pharmaceutical detailers shouldn’t be promoting investigational drugs (no argument there), I’m sure what Mr. Gottfried meant to address is off-label promotion. Perhaps he should have a chat with the folks at the FDA to, um, seek “guidance” on the matter. Or at least he should consult with an attorney familiar with the various and un-subtle legal precedents. (And what about the fact the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.)

Moving from the uninformed to the subjective, the bill states that all pharmaceutical detailers must, “be of good moral character and suitability.” According to whose standards? Elliot Spitzer?Quis custodiet ipsos custodes?

In the “Justification” section, the rational for this legislation states that, “Pharmaceutical companies are increasingly using detailers to go into doctors offices and market their prescription medicines.” But the fact is, for accuracy’s sake, that pharmaceutical detail forces are on the decline. Oops.

But what are facts when you have a research study done by that unbiased arbiter of truth and justice – Public Citizen. In discussing the need for a state-mandated code of ethics, the “Justification” continues, “A 2005 study conducted by Public Citizen and published in The Journal of Public Health Policy found that more than half of the drug makers participating in the 2002 America Psychiatric Association convention violated either the Association's own drug marketing guidelines or FDA rules.”

Further, “Congressman Henry Waxman of the House Committee on Government Reform found that "there has been a marked decline in enforcement actions taken against drug manufacturers by the FDA for illegally promoting their products since December 2001.” Perhaps a conversation with the FDA might enlighten Mr. Gottfried and his co-sponsors to the reality of the situation. (And a primer on federal preemption would also probably be useful.)
If this whole thing sounds familiar – that’s because it is. Remember the District of Columbia “Safe Rx Act of 2007? The devil is in the details – not the detailers.  Read More & Comment...

The Nature of Journal Articles

05/12/2008 05:15 PM |

Very thoughtful and appropriately provocative editorial in the May issue of Nature, "Nothing to see here."  Here's how it begins:

"The Journal of the American Medical Association (JAMA) played a considerable part in manufacturing media outrage last month over an article revealing Merck's use of ghostwriters and rubber stamp experts in the preparation of clinical research articles on Vioxx (rofecoxib).  Although the JAMA article (299, 1800-1812, 2008) revealed nothing new about the ghostwriting practice and so-called guest authorship, the JAMA editors nevertheless felt moved to introduce a new, stricter set of policies on authorship and conflicts of interest."

Here's the complete editorial from Nature:

Click Here to Download

And here's how the editors of Nature conclude their essay:

"But the editors of JAMA and other journals would do well to focus on content, not process.  JAMA's attack casts a cloud over the entire industry.  Stigmatizing any paper that comes from the private sector on the basis of an analysis of one company's poor publishing practices over five years ago is not only unjustified, it is discrimination pure and simple."  Read More & Comment...

Transparency Is Apparently A One Way Street

05/12/2008 10:45 AM |

First, more on the context behind the Brownlee-Lenzer attack on Peter Pitts and Fred Goodwin.  I have written about how the two failed to reveal their bias against SSRIs in their previous selective reporting.  This is relevant since the point of the article Peter and I wrote in the Washington Times "Tabloid Medicine" was precisely about such one-sided coverage about how SSRIs "caused" or were "linked" to suicides.  Turns out that they are, but not in the way people like Brownlee and Lenzer had reported: the decline in SSRI prescribing that fear mongering contributed is associated with an increase in suicides. 

Now comes word from the exec producer of the Infinite Mind that Lenzer pitched a segment about so-called hidden corporate ties in reporting, which was rejected, before running the Slate piece. 

"....In the interest of full disclosure, I also should note for the record that Lenzer, who co-authored the Slate article, called me a few days after the "Prozac Nation: Revisited" program aired to pitch a program that she wanted us to do for The Infinite Mind, called "Journalists on Prozac," which would feature her and her writing partner Shannon Brownlee. Checking into Lenzer's credentials, I found a troubling article in The New York Times taking her to task for a British Medical Journal article that suggested that Eli Lilly and Company, which makes Prozac, had concealed documents about the link between anti-depressants, suicide and violence. The BMJ subsequently retracted the article, with full apologies, and the whole matter was widely covered in the news media.

After we told Jeanne Lenzer that we would not be proceeding with a program featuring her, she and Brownlee wrote the article for Slate."   fray.slate.com/discuss/forums/thread/1237086.aspx

(Lichtenstein also notes that he did not ask Peter about his working for Manning, Selvage and Lee.  Which is true.  But then again, Peter had mentioned it to the producer for the segment in the context of noting that nothing he does for MSL involves CMPI and vice versa.)

One thing Brownlee and Lenzer failed to mention:  all the SSRIs made by the drug companies mentioned in their article have been generic for years. If all drug companies care about is marketing their meds, why would they promote a segment on products they no longer make? 

On another front, and speaking of fronts, the Prescription Project has  released “Toolkits to Guide Hospitals and Medical Schools with Conflicts of Interest”

The guides follow the same flow as the recommendations coming out of the AAMC taskforce. . 

From the titles of the tool kit modules along with the recommendations in the tool kit it appears that they had significant time to digest the AAMC recommendations and take them several steps further to advance their cause (this to be expected).   www.policymed.com/2008/04/aamc-and-prescr.html

The Prescription Project receives funding from trial lawyers and works with Institute for Medicine as Profession, largely funded by George Soros.  IMAP has a project that seeks ultimately to wrest drug development out of the hands of private companies and put it into the hands of government.  

You can see where this is heading ultimately.  Small bites at private sector innovation until nothing is left. 

Lots of people with anti-pharmaceutical innovation bias demand transparency but then hide their own biases, affiliations and funding.  And those that seek to connect the dots and spread their insinuations are equally biased and one-sided.  I think ideas matter and raising the funding link is just a way to divert attention from the debate over substance. 

  Read More & Comment...

Health Care Realities -- What a Concept

05/12/2008 08:34 AM |

Here are some excerpts from Bob Goldberg's excellent piece in today's edition of The Washington Times, "Health Care Realities" ...

Ah, the rites of spring! Baseball, cherry blossoms and the annual report of the Medicare trustees, who duly report that Medicare is going broke. Yet each year we have the routine response of politicians and pundits who wring their hands about the unsustainable rate of growth in health care expenditures.

Here's a typical comment: "Despite a massive increase in health expenditures together with a marked expansion in health workers over the past decade, the nation's health has improved less than expected. The benefits have not appeared to justify the costs. ... We have emphasized high-cost, hospital-based technologies " a situation " made all the more serious by the lack of emphasis on prevention of disease." Those observations were not made yesterday. They were made by Dr. John Knowles in a book titled "Doing Better and Feeling Worse: Health in the United States," published in 1975.

It is useful to look back to see far how we have come even as some things stay the same. In 1974, cardiovascular disease was the cause of 39 percent of all deaths. Today it is about 25 percent. Cerebrovascular diseases were responsible for 11 percent of deaths back then. In 2004 they caused 6.3 percent of deaths. Kidney diseases were linked to 10.4 percent of deaths and now they are associated with 1.8 percent.

Of course, the longer people live the more likely they are to die from cancer or Alzheimer's. The percentages of deaths attributed to influenza and pneumonia have remained almost constant, as have the percentages of people dying from respiratory diseases.

As Harvard University health economist David Cutler has noted: "The average person aged 45 will live three years longer than he used to solely because medical care for cardiovascular disease has improved. Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

As the genetic variations that predict our risk of disease and response to treatment are translated into tests and treatment, the waste from trial and error or unproductive intervention will fall as well. But there is a lot we can do without much effort to save money and improve health. More prevention, shifting care to lower-cost settings and rewarding people for healthier living can move us forward. That's not a crisis; that's an opportunity.

Here's a link to the complete op-ed:

Click Here for Op-Ed

  Read More & Comment...

Where are the dead bodies?

05/12/2008 08:07 AM |

Have you noticed that we're not hearing folks in Washington, DC ask this question any more?

The Lancet 2008; 371:1551
DOI:10.1016/S0140-6736(08)60663-7

Editorial

Combating counterfeit drugs

Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters.

If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries.

The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics.

This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem?

At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking.

Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters.

Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia.

The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters.

There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised.

  Read More & Comment...

Oar Else

05/09/2008 09:00 AM |

Per yesterday’s E&C Subcommittee on Oversight and Investigations "Direct to Consumer Advertising: Marketing, Education or Deception?" hearing (aka:  “MED Ed”), some of the remarks offered by James T. Sage (Pfizer’s Senior Director/Team Leader for Lipitor):

“Pfizer asked Dr. Jarvik to appear in Lipitor advertisements because he is recognized for his work related to the human heart. Dr. Jarvik honestly and sincerely embraced our heart health campaign. He and Pfizer believe the ads were an effective way to deliver an important preventive health message to a large number of people by encouraging them to reduce the risk of heart disease through diet and exercise as well as consultation with their doctors about the importance of managing cholesterol.

Dr. Jarvik received his M.D. degree from the University of Utah College of Medicine in 1976. Although not a practicing physician, he has devoted his entire career to medical science related to the human heart. He has invented medical devices to help patients with advanced heart disease, and has collaborated with other physicians and scientists on these activities. As Dr. Jarvik has said publicly, he has “the training, experience, and medical knowledge to understand the conclusions of the extensive clinical trials that have been conducted to study the safety and effectiveness of Lipitor.”

Both Pfizer and Dr. Jarvik are confident that the statements included in the ads fairly represent the scientific data about Lipitor.

An important objective of the Jarvik advertising campaign for Lipitor was to highlight the importance of diet and exercise in reducing cardiovascular risk. When diet and exercise are not enough, adding medication such as Lipitor may be an important consideration for doctors and patients to discuss.

Some have asked why Pfizer decided to stop using Dr. Jarvik in our advertising. We chose Dr. Jarvik to participate in these ads because he is a nationally prominent expert with the knowledge and experience to speak intelligently and sincerely about the benefits of Lipitor. Unfortunately, the way Dr. Jarvik was presented in these ads has created misimpressions and distractions from our goal of encouraging patient and physician dialogue about the leading cause of death in the world: cardiovascular disease. Going forward, we are committed to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.

In summary, Pfizer believes that it’s important to educate consumers about the risks associated with elevated cholesterol and the value of Lipitor as a potential treatment option. We believe that DTC ads are an effective way of accomplishing that objective.”

Sage views indeed.

  Read More & Comment...

Tribulations and Trials

05/09/2008 08:42 AM |

According to our buddy David Lepay, the FDA's senior advisor for clinical science, the agency and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.

  Read More & Comment...

Kohl Compress

05/08/2008 05:17 PM |

Senator Kohl has assured that $275 million in additional funding for FDA will be included in the Senate version of the FY 2008 emergency supplemental bill.  The Senate Appropriations Committee mark-up is scheduled for next week. The fate of the Kohl amendment is likely to be decided, in part, by House and Senate leadership when they determine the extent to which final Congressional legislation will fund programs other than defense and the war effort.

We'll see.

  Read More & Comment...

Mission Impossible or Risky Business?

05/08/2008 02:09 PM |

Apparently Shannon Brownlee buys into the Tom Cruise notion of mental illness, that it is some mystery or perhaps (my inference with no basis) a Thetan induced stated of disturbance. Here's Ms. Brownlee 'splaining what depression and manic depression is really all about...

"The mind and its illnesses remain as mysterious as the cosmos.."

Meanwhile, all scientists did was support the drug companies in developing medicines that were based on a flimsy excuse to abandon Freud.  Shannon again:

"It's not as if physicians can administer a blood test to determine if a patient is depressed or anxious or obsessive-compulsive. Rather, psychiatry defines -- and diagnoses -- psychiatric disorders on the basis of subjective symptoms that are reported by patients or observed by doctors."

Right, and there are no blood tests for Alzheimer's, Parkinson's, MS, dementia, cerebral palsy or schizophrenia...so I guess there aren't real diseases either...

Brownlee then crosses the Neutral Zone and into Scientology territory...

"The notion that depression is a biological ailment, like Alzheimer's, proved enormously appealing to patients. It relieved much of the stigma of mental illness, which could now be viewed not as a personal or moral failing, but as a glitch of biology. The serotonin theory also appealed to the medical community, for a slightly different reason. It made the mind seem more knowable, less like a black box, and psychiatry seem more like real science, instead of a lot of Freudian talk about repression and sex. Psychiatrists could now say to patients, you are sick because of a deficiency, and these drugs will restore you to normalcy and mental health.

If only psychiatric disease were that simple. In reality, there is little research to show that being a quart low on serotonin leads to depression, and even less to suggest that patients who commit suicide have lower levels of serotonin than normal people. And nobody really knows what SSRIs actually do in the human brain."

This is called ignorance by choice. 

So of course the marketing and prescribing of drugs to people who don't need will lead to horrible events like death, anxiety, etc.  But Brownlee and the Scientology types beg a question:  if mental illness is not biological in nature, and we know so little about serotonin and other neurotransmitters, how would drugs that can't restore people to health then harm so many?

Sorry, I am interrupting her rant:

"What's more likely is that the field of psychiatry, with its shifting, subjective diagnostic categories and its enthusiasm for new drugs, has been acutely vulnerable to "disease mongering." This is the increasingly common practice on the part of the pharmaceutical industry to broaden the perceived market for a drug by persuading doctors and the public that huge numbers of people suffer from this or that disorder. Between disease mongering and some doctors handing out SSRIs like Pez, antidepressant prescriptions for children have surged 27 percent since the mid-1990s. Today, between 1 million and 3 million kids under the age of 19 are on one or more of these drugs for diagnoses ranging from attention deficit disorder to migraines to schizophrenia. Taking SSRIs has become so commonplace that young people talk casually about needing to "adjust their meds" in response to a rough week at school or a bad breakup.

Meanwhile, doctors have been prescribing these medications without knowing until just recently that, according to the FDA, 2 to 3 percent of their young patients could be at risk for drug-induced suicidal thoughts or actions. Maybe that's because academic psychiatry has been too busy performing research with a very different agenda to answer the fundamental questions. In their haste to partake of industry research funds and other perks, academic researchers have focused much of their effort on what Carroll calls "experimercials" -- studies aimed at expanding the drugs' "off-label," or unapproved, markets.

And so doctors still can't tell which patients are most likely to benefit from taking an SSRI. Nor can they predict which ones are most likely to suffer devastating reactions. They still don't have any idea how, biochemically, the drugs might trigger suicide and bipolar disorder. In his book "Let Them Eat Prozac," psychiatrist Healy writes that the story of the SSRIs "reveals a lack of research so complete that academics cannot avoid questions about how well the health science research community serves us."

PS  David Healy is a paid expert witness for trial attorneys.  Something Brownlee never mentions...

Add her bias against using medicines to treat mental illness, indeed her belief that mental illness is just a  marketing gimmick, you might understand why she and Jeanne (I stole the documents) Lenzer who openly collaborated with Peter Breggin (who has his own ties to Scientology) would attack Fred Goodwin and Peter. 

Like I said, context matters.  And there is a lot more of it to come. 

paxilprogress.org/forums/showthread.php  Read More & Comment...

MED Ed

05/08/2008 08:26 AM |

Today's House hearing on pharmaceutical DTC goes forward under the title,"Direct to Consumer Advertising: Marketing, Education or Deception?"  Let's just call it MED Ed.

The prosecution (yes, because it's really a show trial) is led by Representative Bart Stupak (D, MI).  Nuff said.

The real action (meaning where real and meaningful conversations will take place on this issue) takes place later this month when the FDA advisory committee on risk communications meets to discuss DTC and how it can be made better.

That's the right way to do things.

As far as today's hearing being good theater, my advice is to go see Ironman.

(Per full disclosure, neither www.drugwonks.com nor www.cmpi.org receives any funding from Marvel Comics.)

  Read More & Comment...