Dangerous Prescriptions- Frontline Program

In this Frontline Program, they are investigating our drug safety system. This program is from 2003 and years before the scandals with Vioxx, Celebrex, Avandia, and Paxil; nevertheless, the basic information and analysis of the problems in drug safety are still relevant. -Duncan



In "Dangerous Prescription," FRONTLINE® investigates the integrity of America's drug safety system. Through interviews with current and former FDA officials, critics, a pharmaceutical industry representative, and consumers, the one-hour documentary examines the FDA's handling of several drugs that were approved but later were pulled from the market after causing injuries and even deaths. The program also examines the role that drug companies play in the approval and monitoring of prescription drugs, and questions whether the FDA's current system is adequate for protecting the public.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/synopsis.html

http://snipurl.com/35zh9

Drugs and Kids- Frontline Program

In our rushed "let's solve this problem now" culture, more and more children are being given a mental or biochemical disease label and put on drugs designed and tested only on adults. The Frontline TV program linked here takes you to a 2001 analysis with a current (2008) update. This is a serious issue for all involved the kids, the parents, the schools, the culture. -Duncan



In recent years, there's been a dramatic increase in the number of children being diagnosed with serious psychiatric disorders and prescribed medications that are just beginning to be tested in children. The drugs can cause serious side effects, and virtually nothing is known about their long-term impact. "It's really to some extent an experiment, trying medications in these children of this age," child psychiatrist Dr. Patrick Bacon tells FRONTLINE. "It's a gamble. And I tell parents there's no way to know what's going to work." (more »)

In Case You Are Wondering about the Money

Please take a look at the last column which displays % of growth if you want a snapshot of the action in the pharmaceutical field.

Objective Medical Information??

So how many times have you gone to Medscape for medical information thinking that it was objective medical science. This excerpt below is an eye opener for those of us who keep the image of the public medical servant who always has the best interest of the patient in mind. The excerpt is from the Carlat Psychiatry Blog and a link to the full post is given below. -Duncan




Medscape is a medical education communication company entirely dependent on drug company advertising and CME funding for its existence. Many doctors have noticed recently that the company has dropped even the pretense of objectivity. Yesterday, I received a letter from Medscape in my office; inside was a brochure from Forest Laboratories advertising Lexapro, and nothing else. It was creepy, like Invasion of the Body Snatchers.

If you want to judge for yourself whether Medscape is capable of producing unbiased CME, go to their main CME page. You'll find dozens of CME articles, almost all of which are sponsored by different companies.

Here's one that can serve as a poster child for all that is wrong with industry-funded CME. Entitled "Managing Schizophrenia in a Patient With Alcohol Abuse and Hepatic Impairment", it is sponsored by Janssen, maker of Invega, a "new" antipsychotic which is simply the active metabolite of their now off-patent drug, Risperidone. As I've written here in The Carlat Psychiatry Report, Invega is simply a patent extender, with no real benefit other than the fact that it is not metabolized in the liver, and therefore is easier to dose in patients with hepatic impairment. In the grand tradition of promotional CME, Janssen commissioned Medscape to come up with a case-based program focussing on the single clinical situation in which Invega has an advantage.

http://carlatpsychiatry.blogspot.com/2008/06/medscapes-cme-corruption.html
--

Putting Lipstick on a Pig

Here's another tidbit from Jim Edwards' NRx blog. The background is that many folks taking antidepressants are not enjoying much of a sex life these days so somebody decided that they would add some viagra to the mix for women. Now it is interesting that Pfizer says it is not going to apply to the FDA for permission to sell viagra to women on antidepressants. I guess they decided to fund the viagra for orgasm study out of the kindness of their scientific hearts.

It some ways this is a small story but one of those stories which highlights many of the most pressing issues in pharmaland: research design, pharma funding for research, stretching of the conclusions of the study etc. - Duncan


What's Wrong with That 'Viagra for Women' Study in JAMA?

Plenty.

The media has gone bonkers for this study which purports to show that women with sexual dysfunction brought on by anti-depressant use can get their orgasms back by taking Pfizer's Viagra. Google News had upwards of 476 stories on the study at the time of writing.

(NRx highlighted the Great Orgasm Robbery a couple of days ago. Summary: Anti-depressants rob you of your sex life, subjecting you to dystopian side effects such as the "pleasureless orgasm.")

But the study has problems, bears many of the hallmarks of garbage science, and raises serious questions about why JAMA would publish it.

Among the issues:

+ There were only 98 women in the trial. Forty nine of them were on the placebo and 49 were on Viagra.

+ Only 39 on Viagra actually completed the study.

+ Only 72% of those women reported improvement.

+ Which means that only 28 actual women reported improvement.

So that's it: 28 depressed women have an orgasm and the media goes crazy.

(The good news? At least nobody got cancer.)

The difficulties with the study don't end there.

Pfizer, the maker of Viagra, funded the study. And the doc who carried it out has taken Pfizer money before.

All the women are taking two drugs, an antidepressant plus Viagra, making it difficult to presume whose symptoms were being caused by what.

To qualify, their depression had to be in "remission" (meaning they were the type of patients who were already responding nicely to drugs, treatment, or were getting better on their own).

And the headline stat — that 72% of women taking happy pills plus Viagra get their orgasms back — masks some very odd data lower down in the results tables.

Check out the results in the study that are not about orgasms. "Arousal" got a P value of .81. "Sexual arousal" got .61. "Lubrication" got .64. "Sexual drive" got .40.

If one assumes the .01 value for orgasm was significant, then these other results suggest that although the women got their orgasms back, they didn't get back all the other stuff that goes along with them.

In other words, the one thing that makes this study interesting is that it may have provided hard proof of the reality of the pleasureless orgasm phenomenon.

And can we just remind ourselves of the fact that the reason these women are sexually dysfunctional is because they're taking the kind of drugs — such as Zoloft — that are made by Pfizer, in the first place?

http://jimedwardsnrx.wordpress.com/

http://snipurl.com/34vrr

Medical waste estimates.Unbelievable even if only half true!

PricewaterhouseCoopers is a Big Four auditor, alongside KPMG, Ernst & Young and Deloitte Touche Tohmatsu. In other words, PWC are major bean counters(accountants), not exactly folks to make radical statements.

Yet they estimate that more than half of all healthcare expenditures are wasteful. And that "more than half" is a whole lot of money: 1.2 Trillion dollars.

This is so big that it is easy to just glance over a figure like that without it making an impact but for example, less than 1/4 that amount could renovate all of the water infrastructures in the entire US of A.

So where is the wasteful spending going:

1. unnecessary tests and procedures.

2. inefficient administration

3. treatment of diseases better treated through lifestyle modifications, i.e. weight control, stop smoking, better nutrition, drug and alcohol programs.



Here are some excerpts from the PriceWaterhouseCooper site: You can download the complete report if you want all the nittygritty -Duncan

As part of its preparation for the 180° Health Forum, PricewaterhouseCoopers' Health Research Institute (HRI) interviewed more than 20 participants, reviewed more than 35 studies about waste and inefficiency in healthcare and surveyed 1,000 consumers to understand the public's perception of waste and inefficiency in the system. From that research came The price of excess:

Identifying waste in healthcare spending.

Key Findings

Our research found that wasteful spending in the health system has been calculated at up to $1.2 trillion of the $2.2 trillion spent in the United States, more than half of all health spending. Defensive medicine, such as redundant, inappropriate or unnecessary tests and procedures, was identified as the biggest area of excess, followed by inefficient healthcare administration and the cost of care necessitated by conditions such as obesity, which can be considered preventable by lifestyle changes. PricewaterhouseCoopers' paper classified health system inefficiencies into three "wastebaskets" that are driving up costs:

* Behavioral where individual behaviors are shown to lead to health problems, and have potential opportunities for earlier, non-medical interventions.
* Clinical where medical care itself is considered inappropriate, entailing overuse, misuse or under-use of particular interventions, missed opportunities for earlier interventions, and overt errors leading to quality problems for the patient, plus cost and rework.
* Operational where administrative or other business processes appear to add costs without creating value.

When added together, the opportunities for eliminating wasteful spending add up to as much as $1.2 trillion. The impact of issues such as non-adherence to medical advice and prescriptions, alcohol abuse, smoking and obesity are exponential, and fall into all three baskets.

link to PWC
http://tinyurl.com/64lcfg

Gives a Whole New Meaning to "Sex and Drugs"

Here's a story from Jim Edwards' blog NRx. He gives some facts and figures on how SSRI's are having a devastating effect on people's sex lives. We have been going through all these years thinking about how sex and drugs were connected in a positive correlation(more drugs, more sex) when all of a sudden they have an negative correlation(more drugs, less sex).

Not to worry though. Another story of the day is about how a research study shows that if women taking Paxil are experiencing a rotten sex life, the solution is to take Viagra. A wonderful deal for Pfizer which just happens to manufacture both drugs. Ain't chemistry wonderful!!! -Duncan

Worst Side Effect Ever: The 'Pleasureless Orgasm'
July 21, 2008


File this one under "Why isn't this on the front page?!" It's a natural audience-grabber that actually has some proper science behind it:

SSRI antidepressants — such as Paxil, Lexapro, Zoloft, Luvox and Prozac — have rates of "decreased libido, delayed orgasm, anorgasmia, erectile dysfunction, and difficulties with arousal, of between 36 and 70%," according to a new study.

First reported on the excellent (but badly named) psychiatry blog "Clinical Psychology and Psychiatry: A Closer Look," the study is a comprehensive review of sexual side effects triggered by selective serotonin re-uptake inhibitors. (That's happy pills, for us lay-folk.)

One of the worst side effects, seemingly designed by the devil himself, is the "pleasureless orgasm." The condition goes hand in hand with "genital anaesthesia" (meaning "can't feel anything," presumably).

Let's do a little math: According to Scientific American, close to 10% of Americans are on antidepressants. Let's make it easy and say that's 30 million of 300 million yanks. Of those, possibly 23 million are walking around in a state of sexual frustration. And they have partners — so that's somewhere in the neighborhood of a possible 46 million of us who are inexplicably tetchy and bad tempered on most days. (Yes, I know that some of them will be dating each other — but you can see my point.)

http://jimedwardsnrx.wordpress.com/2008/07/21/worst-side-effect-ever-the-pleasureless-orgasm/

http://snipurl.com/33a84

Bad Science in Action Comix

Go here for more Mike Belkin strips: http://mikebelkin.com/

Cancer docs profit from chemotherapy drugs

FYI



Cancer docs profit from chemotherapy drugs
Situation begs the ethical question: Are they overprescribing?
By Rehema Ellis
Correspondent
updated 6:34 p.m. CT, Thurs., Sept. 21, 2006

NEW YORK — It is a unique situation in medicine: Unlike other kinds of doctors, cancer doctors are allowed to profit from the sale of chemotherapy drugs.

"The significant amount of our revenue comes from the profit, if you will, that we make from selling the drugs," says Dr. Peter Eisenberg, a private physician who specializes in cancer treatment.

Doctors in other specialties simply write prescriptions. But oncologists make most of their income by buying drugs wholesale and selling them to patients at a marked up prices.

http://www.msnbc.msn.com/id/14944098/print/1/displaymode/1098/

click here for the full story
http://snipurl.com/31ntc

Science isn't always Science and The Data is not alway the Data

We almost all know enough not to automatically trust politicians and salespeople, but still it is so easy to think that a scientist or a doctor are true professionals that hold truth to be more important than money, power or glory. Sad but not so true, especially since there is so much money to be made. Below is an excerpt from a much large article by Shannon Brownlee which appeared in 2004 in the Washington Monthly.

I have excerpted because I feel it highlights the nexus of the problem: we trust and there are those that abuse that trust because they can profit.





From the article:

Isn't science, well, scientific, an objective search for the truth? That's what many academic clinicians, especially those who are mixed up with corporate sponsors, would have the public believe. A typical comment comes from Niels Reimers, an early promoter of industry-university ties, who told the Hartford Courant, "You may think I'm a Pollyanna or something, but most people are honest. It's sort of the ethos of academic research." Here's Dr. Irwin Goldstein, a Boston University urologist who has consulted for at least seven companies developing impotence therapies: "Science is science. It comes down to the bottom line. What the data shows, the data shows."

Such statements reflect the ideal of science, not the reality, says Dr. Marcia Angell, former editor in chief of The New England Journal of Medicine. Public protestations aside, she says,

"Clinicians know privately that results can be jiggered. You can design studies to come out the way you want them to. You can control what data you look at, control the analysis, and then shade your interpretation of the results." <my emphasis>

Even the most careful research can be fraught with murky results that require sifting and weighing, a measure of judgment that the researcher hopes will bring him closer to the truth. Was this patient's headache caused by the antibiotic you gave her, or does she have a history of migraines? Is that patient's depression lifting because of the drug you are testing, or because a kindly doctor is actually listening to him?

for the full article click on the link below

http://www.washingtonmonthly.com/features/2004/0404.brownlee.html

http://snipurl.com/31kgc

The Betrayal of Science by Universities and Medical Schools

Audrey Blumsohn has some very pertinent comments to make about academic institutions that harbor "scientists" that act in unethical ways. Audrey's comments can be found at http://scientific-misconduct.blogspot.com/


It's all very well blaming pharmaceutical companies for the decrepit state of integrity in medicine.

The chief villians remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students.



http://snipurl.com/318vm

AMA Wants to Control Births

Ladies, the physicians of America have issued their decree: they don't want you having your babies at home with midwives.

We can't imagine why not. Study upon study have shown that planning a home birth with a trained midwife is a great choice if you want to avoid unnecessary medical intervention. Midwives are experts in supporting the physiological birth process: monitoring you and your baby during labor, helping you into positions that help labor progress, protecting your pelvic parts from damage while you push, and "catching" the baby from the position that's most effective and comfortable for you -- hands and knees, squatting, even standing -- not the position most comfortable for her.

When healthy women are supported this way, 95% give birth vaginally, with hardly any intervention.

And yet, the American Medical Association doesn't see the point. Yesterday at its annual meeting it adopted a policy written by the American College of Obstetricians and Gynecologists against "home deliveries" and in support of legislation "that helps ensure safe deliveries and healthy babies by acknowledging that the safest setting for labor, delivery, and the immediate post-partum period is in the hospital" or accredited birth center.

"There ought to be a law!" cry the doctors.

The trouble is, they have no evidence to back up their safety claims. In fact, the largest and most rigorous study of home birth internationally to date found that among 5,000 healthy, "low-risk" women, babies were born just as safely at home under a midwife's care as in the hospital. And not only that, the study, like many before it, found that the women actually fared better at home, with far fewer interventions like labor induction, cesarean section, and episiotomy (taking scissors to the vagina, a practice that according to the research should be obsolete but is still performed

Rest of the story:

http://www.huffingtonpost.com/ricki-lake-jennifer-block-and-abby-epstein/docs-to-women-pay-no-atte_b_107845.html

http://snipurl.com/30okq

Unsavory Relations between Big Pharma and Most Med Schools

Only 5% of Medical Schools were judged free of conflicts of interest between their educational mission and a cosy relationship with pharmaceutical companies.





June 3, 2008
Survey of Medical Schools Is Critical of Perks
By GARDINER HARRIS

Most medical schools in the United States fail to police adequately the money, gifts and free drug samples that pharmaceutical companies routinely shower on doctors and trainees, according to a ranking by the American Medical Student Association.

Only 7 of the 150 medical schools included in the rankings received a grade of A while 14 were given a B. Sixty got a failing grade, and the student association found that 28 schools, or nearly one in five, were in the midst of revising their conflict-of-interest policies.

Click the link for the full story

http://www.nytimes.com/2008/06/03/health/03conflict.html?_r=1&oref=slogin&pagewanted=print

http://snipurl.com/30gh2

Vioxx and Extra Heart Attacks

vioxxThe vioxx story is certainly a cautionary tale. I will be collecting a number of Vioxx stories because it is a very clear example of either corporate malfeasance or sloppy research with poor oversight.


Up to 140,000 heart attacks linked to Vioxx

* 00:01 25 January 2005
* NewScientist.com news service
* Shaoni Bhattacharya


Up to 140,000 extra heart attacks may have been caused in the US by the recently withdrawn drug Vioxx since its launch in 1999, suggests a new study. And millions of people may have been exposed unnecessarily to the risk of heart attack by taking Cox-2 inhibitor drugs, including Vioxx, when they did not need the medicines, according to a second study.



http://www.newscientist.com/article.ns?id=dn6918

http://snipurl.com/30aal

Drugs, Seniors, Falling

All pharmaceuticals need to be analyzed completely including what their total effect on the patient is. In this case, the patients are elderly, a group for which falling can be quite devastating. I thank the folks at the Wall Street Journal Health Blog for this post.


July 16, 2008, 1:52 pm
Which Drugs Do — And Don't — Increase Fall Risks for the Elderly
Posted by Scott Hensley


Falls are the leading cause of injury deaths for people 65 and older, and they're the most frequent reason for trauma admissions among the elderly, according to the Centers of Disease Control and Prevention.

The drugs older people take can make them more susceptible to falling. That's why researchers at the University of North Carolina in Chapel Hill are mobilizing pharmacists in drugstores to advise older folks and their doctors on drug choices that could lower the risk.

While the first results of UNC's federally funded test of the approach won't be known until later this year, we caught up with some of the researchers on the project recently. The basic problem is that patients — and even their physicians — are unlikely to be aware of all the side effects that common medicines can have, Susan Blalock, an associate professor at UNC's pharmacy school, told us.

Drugs ranging from sleeping pills to painkillers can make people woozy, confused or interfere with balance. To cut the risk of falls, the UNC researchers are focusing on the options among nine groups of medicines. For a look at the best and worst choices by category, see the appendices to the study in the June issue of the American Journal of Geriatric Pharmacotherap


http://snipurl.com/302y5

Good Source of Drug Information

I find that I am going to www.drugs.com when I want to investigate pharmaceuticals. What I appreciate is their professional information which includes data comparing the side effects of particular drugs with the placebo.

Another valuable tool is their drug interaction feature. You need to register to use this but it is very simple to do so. Look for the link on the right of their homepage.

This is the best all around website for pharmaceutical information I have found so far, if you know of a better one or one that has additional information let me know. I promise I will check the sites you suggest.

"more care does not always mean better care."

Below is an excerpt from a report by Maggie Mahar called "Making Choice an Option", it is part of a 10 page pdf file. In the report Mahar does an excellent job of helping us understand that "more care does not always mean better care."


Medicare beneficiaries in high-cost
states are likely to spend twice as many days in the
hospital as patients in low-cost states and are far
more likely to die in an intensive care unit. The
odds are higher that patients in high-spending regions
will see 10 or more specialists during their fi-
nal six months of life. These facts alone aren’t terribly
surprising. But here’s the stunner: Chronically
ill patients who receive the most intensive, aggressive,
and expensive treatments fare no better
than those who receive more conservative care. In
fact, their outcomes are often worse.
In high-cost regions, “patients with the same disease
have higher mortality rates, very likely because
of medical errors associated with increased use of
acute-care hospitals,” Wennberg and colleagues
noted in a 2006 study of patients suffering from
chronic diseases like cancer or congestive heart failure.
As Fisher puts it, “Hospitals can be dangerous
places—especially if you don’t need to be there.”

You can download the rest of the report by clicking the link below

http://www.tcf.org/list.asp?type=PB&pubid=627

A Fine Distinction: Withdrawal vs. Discontinuation

In my line of work as an acupuncturist, I encounter many patients that have been on specific pharmaceuticals for years and feel trapped into taking them for fear of what will happen when they stop. So I find the following description to be food for thought.



Ninan: First of all, I think, one should distinguish what is a withdrawal syndrome from what we would call discontinuation symptoms. Withdrawal is traditionally associated with medicines that one has got physiologically dependent on. And there is a whole set of not only symptoms, but physiological changes that occur that can be potentially dangerous.

You see that with alcohol, you see that with benzodiapams, the anti-anxiety and sleep medications that can cause physiological dependence. And you see that with pain medications, particularly opiates and that class of medications. So, those can be medically problematic and potentially dangerous in some people.

We should distinguish that from discontinuation symptoms, where those medical risks are not present. And these are not medicines that you become physiologically dependent on, but you can get adaptive changes that have occurred, that then the body and the brain needs to readapt to not having those medications on board.

Follow the link for more of the interview.

http://www.pharmalot.com/2008/07/withdrawal-discontinuation-different-animal/

http://snipurl.com/2zgid

BTW when you follow the link to pharmalot be sure to take a look at the comments, they are quite thoughtful and offer a variety of informed perspectives.

Paxil on Trial

I am going to check into this book, found a reference to it on the pharmalot blog.

"Alison Bass has put on trial in her book far more than just a bestselling antidepressant--she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller...." -The New England Journal of Medicine

http://www.alison-bass.com/


Here is another current tidbit related to the antidepressant, Paxil and unsavory behavior.

Among the 30 or so physicians at two dozen universities that the Senate Finance Committee is probing concerning disclosure of grants from drugmakers is Martin Keller, a psychiatrist at Brown University who is a controversial figure for his role in studying Glaxo's Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter to Brown as part of its investigation. We are awaiting a reply from Brown and will update you shortly.

http://www.pharmalot.com/2008/07/grassley-targets-browns-keller-over-grants/

http://snipurl.com/2zgd1

US Drug Costs Twice That of UK

......the US Government is already the biggest buyer in the US pharmaceutical market. Americans spend about £140 billion annually on medicine, compared with £11 billion in the UK. According to World Health Organisation statistics, American expenditure per head on healthcare is double the amount in Britain and a large part of that higher investment is related to the cost of drugs.

On average, for the same drug, an American pays twice that paid in the UK. American insurers pick up a great deal of the bill and their lack of efficiency is a big bone of contention, but the heaviest burden falls on the taxpayer because 45 per cent of total expenditure on healthcare in America is borne by government.

It's a colossal bill, but the American taxpayer doesn't get any pricing power for his dollar. In Britain, most other European countries and Canada, national agencies, such as the NHS, negotiate with the pharma giants, bully suppliers and set tariffs for a list of approved drugs.

In the US, such intervention is anathema - the US Food and Drugs Administration (FDA) approves drugs for their safety, but price and availability are market-driven and the drug barons argue that freedom leads to choice, a multiplicity of products and more rapid introduction of new medicines.

Taken from : business.timesonline.co.uk

http://snipurl.com/2zg3u

Interactive Health Map

This link takes you to an interactive health map based on information from The Dartmouth Health Atlas:

http://www.nytimes.com/ref/business/20070611_GAP_GRAPHIC.html

Merck Vioxx Deception Death

Ah, yes, Vioxx, what a tale!! Here is a tale of corporate skullduggery well done by the Washington Post. There will be more post detailing this sordid saga.


Maker of Vioxx Is Accused of Deception

By David Brown
Washington Post Staff Writer
Wednesday, April 16, 2008; A01

Two teams of researchers with access to thousands of documents gathered for lawsuits over the painkiller Vioxx allege that Merck waged a campaign of deception to promote its drug, moving slowly to warn of possible hazards while at the same time dressing up in-house studies as the work of independent academic researchers.

The reports in today's Journal of the American Medical Association in effect accuse one of the world's biggest pharmaceutical makers of various forms of scientific fraud.

One study alleges that Merck gave the Food and Drug Administration an incomplete accounting of deaths in a clinical trial of Vioxx in people with mild dementia. Federal regulators eventually received the data, which added to growing evidence that Vioxx increased the risk of heart attacks and strokes.

Simultaneously, Merck was using what the JAMA authors call "guest authorship and ghostwriting" to make it appear that research done by its employees or contractors was the work of scientists at medical schools and universities. That presumably gave the findings more credibility when they were published, in medical journals, boosting Vioxx's profile in the crowded painkiller market.

Vioxx, whose generic name is rofecoxib, went on the market in 1999. It became a "blockbuster," with $2.3 billion in sales in 2003, but Merck voluntarily withdrew it in September 2004 after several studies showed that it increased the risk of heart attacks and strokes.

http://www.washingtonpost.com/wp-dyn/content/article/2008/04/15/AR2008041502086_pf.html

http://snipurl.com/2z3h6

Money, Doctors, Pharma and NPR

Here is an article from Slate (a great online magazine) that shows just how tricky the moral terrain becomes when professional researchers and physicians receive monies from the pharmaceutical industry.


Stealth Marketers
Are doctors shilling for drug companies on public radio?
By Shannon Brownlee and Jeanne Lenzer
Updated Friday, May 9, 2008, at 8:16 PM ET

A few weeks ago, devoted listeners of National Public Radio* were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

We don't know just how much funding or when the show last received it, since neither Goodwin nor the show's producers responded to repeated requests for interviews. But the larger point is that undisclosed financial conflicts of interest among media sources seem to be popping up all over the place these days. Some experts who appear independent are, in fact, serving as stealth marketers for the drug and biotech industries, and reporters either don't know about their sources' conflicts of interests, or they fail to disclose them to the public.

Take the November 2006 NBC Nightly News story that asked, "Can lung scans really prevent cancer death?" Reporter Mike Taibbi, a former smoker, underwent scanning by Dr. Claudia Henschke, a professor of radiology at Weill Cornell Medical College in New York. Henschke claimed on the show that early detection with lung scans could prevent 80 percent of deaths from lung cancer. Although Taibbi included another expert who said that Henschke's claim was "outrageous," viewers were left with little way to evaluate the two conflicting viewpoints. And Taibbi himself concluded that early detection was his "best chance." At no point did viewers learn that Henschke's research was funded by a tobacco company, which has an investment in making the risks of smoking appear to be manageable—or that many experts warn that more research is needed to determine whether the potential benefits of scanning outweigh its harms.

How frequently are journalists glossing over such conflicts? Gary Schwitzer, a professor of journalism at the University of Minnesota, is the publisher of HealthNewsReview.org, a Web site that reviews health care news for balance, accuracy, and completeness. Schwitzer and his team of reviewers have looked at 544 stories from top outlets over the two-year period from April 2006 to April 2008. Journalists had to meet several criteria in order to receive a satisfactory score, among them: They had to quote an independent expert—someone not involved in the relevant research—and they had to make some attempt to report potential conflicts of interest. Half the stories failed to meet these two requirements, Schwitzer says.

Conflicts of interest abound even in unexpected places. A recent survey of academic medical centers published in the Journal of the American Medical Association found that 60 percent of academic department chairs have personal ties to industry—serving as consultants, board members, or paid speakers, while two-thirds of the academic departments had institutional ties to industry. Such ties can be extremely lucrative. And according to these articles in the medical literature, researchers who receive funding from drug and medical-device manufacturers are up to 3.5 times as likely to conclude their study drug or medical device works than are researchers without such funding.

An equally clever way for companies to get out their marketing messages is to go through a consumer group. Drug companies often seed "pharm teams," consumer groups that start out as legitimate advocacy organizations and are subtly manipulated by funding from pharmaceutical companies to convey the desired talking points. Unless reporters ask where groups and individual researchers get their money, they have no idea that their sources may be biased—and neither do their readers, viewers, and listeners.

Which brings us back to The Infinite Mind and "Prozac Nation: Revisited," a show that may stand in a class by itself for concealing bias. In addition to the show's unrestricted grants from Lilly, the host, Goodwin, is on the board of directors of Center for Medicine in the Public Interest, an industry-funded front, or "Astroturf" group, which receives a majority of its funding from drug companies. CMPI President Peter Pitts was one of Goodwin's three guests for "Prozac Nation." We don't know which companies fund his group because when we asked him, Pitts said, "I don't want to go into that." But CMPI took in more than $1.4 million in 2006 and, according to its tax forms, spent $210,000 to influence the media through a large conference, a blog the group maintains, op-eds published in major newspapers, and multimedia programs and podcasts. Pitts has another title that might have been relevant to The Infinite Mind; he is the senior vice president for global health affairs at the PR firm Manning Selvage & Lee, which represents Eli Lilly Inc., GlaxoSmithKline, Pfizer, and more than a dozen other pharmaceutical companies. Yet on the show, Pitts was identified only by his title as "a former FDA official."

The second guest on "Prozac Nation," Andrew F. Leuchter, is a professor of psychiatry at UCLA who has received research money from drug companies including Eli Lilly Inc., Pfizer, and Novartis. The third guest, Nada Stotland, president-elect of the American Psychiatric Association, has served on the speakers' bureaus of GlaxoSmithKline and Pfizer. None of Leuchter and Stotland's ties to industry was revealed to listeners—instead, each was introduced as a prominent academic.

The Infinite Mind's Web site states, "Our independence is perhaps our greatest asset." Perhaps, indeed. Neither Goodwin nor the show's producers responded to our repeated requests for interviews and queries about their funding. Pitts, who to his credit did give us an interview, said he didn't know why his ties to industry weren't revealed on the show. Curious, we tried to learn more about the funding for The Infinite Mind—and could discover only that the show's award-winning production company, Lichtenstein Creative Media, was dissolved by the state of Massachusetts on March 28 for failing to file a single annual report since its establishment in 2004.

Some reporters and producers argue that they can't be expected to ask every source whether he or she gets money from the drug industry. But there are obvious first steps to take. A list of academic researchers who are known to have financial ties to the drug and medical-device industries is available through the Center for Science in the Public Interest. (Yes, the name is a lot like the Astroturf group we mentioned earlier—coincidence?) To be fair, the list is inevitably incomplete, and Astroturf groups and academics with undeclared financial ties can make it difficult to ferret out their financial conflicts.

In hopes of making reporters' jobs a little easier, we've created for journalists an international list of prestigious and independent medical experts who declare they have no financial ties to drug and device manufacturers for at least the past five years. We have nearly 100 experts from a wide array of disciplines. E-mail us at Brownlee.Lenzer@gmail.com, and we'll be happy to name names.

Correction, May 9, 2008: After this piece posted, Slate posted a correction saying that the piece had incorrectly stated that The Infinite Mind is carried on National Public Radio, rather than public radio stations. We now understand from NPR's ombudsman, Alicia Shepard, that it was the correction that was wrong. In fact, NPR has a contractual relationship with The Infinite Mind to run the show on two Sirius channels. The show also runs on NPR member stations. Return to the corrected sentence.)
Shannon Brownlee is a Schwartz senior fellow at the New America Foundation. Her e-mail address is brownlee@newamerica.net.
Jeanne Lenzer is a freelancer whose work appears regularly in the medical journal BMJ. Her e-mail address is jeanne.lenzer@gmail.com.

Article URL: http://www.slate.com/id/2190775/

Copyright 2008 Washingtonpost.Newsweek Interactive Co. LLC

Pharma Money Maybe Funny Business

Pharma Money Maybe Funny Business



One of the major problems with the exchange of money between
pharmaceutical companies and professional health organizations and
practitioners is the possibility of the money tainting the objectivity
of the professional recommendations. Below is a clear example of how
this behavior muddies the scientific waters, especially in light of
recent studies that question the effectiveness of antidepressants.

Below is an article from the New York Times, at the end of the article
is a link to the story in the online pages of the Times.

July 12, 2008
Psychiatric Group Faces Scrutiny Over Drug Industry Ties
By BENEDICT CAREY and GARDINER HARRIS

It seemed an ideal marriage, a scientific partnership that would
attack mental illness from all sides. Psychiatrists would bring to the
union their expertise and clinical experience, drug makers would
provide their products and the money to run rigorous studies, and
patients would get better medications, faster.

But now the profession itself is under attack in Congress, accused of
allowing this relationship to become too cozy. After a series of
stinging investigations of individual doctors' arrangements with drug
makers, Senator Charles E. Grassley, Republican of Iowa, is demanding
that the American Psychiatric Association, the field's premier
professional organization, give an accounting of its financing.

The association is the voice of establishment psychiatry, publishing
the field's major journals and its standard diagnostic manual.

"I have come to understand that money from the pharmaceutical industry
can shape the practices of nonprofit organizations that purport to be
independent in their viewpoints and actions," Mr. Grassley said
Thursday in a letter to the association.

In 2006, the latest year for which numbers are available, the drug
industry accounted for about 30 percent of the association's $62.5
million in financing. About half of that money went to drug
advertisements in psychiatric journals and exhibits at the annual
meeting, and the other half to sponsor fellowships, conferences and
industry symposiums at the annual meeting.

This weekend in Chicago, the psychiatry association's board will meet
behind closed doors, in part to discuss how to respond to the
increasingly intense scrutiny and questions about conflicts of
interest.

"With every new revelation, our credibility with patients has been
damaged, and we have to protect that first and foremost," said Dr.
Steven S. Sharfstein, a former president of the association and now
president of the Sheppard Pratt Health System in Baltimore. "I think
we need to review all arrangements between doctors and industry and be
very clear about what constitutes a conflict of interest and what does
not."

One of the doctors named by Mr. Grassley is the association's
president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8
million stock holdings in a drug development company raised the
senator's concern. In a telephone interview, Dr. Schatzberg said he
had fully complied with Stanford's rigorous disclosure policies and
federal guidelines that pertained to his research.

Blocking or constraining researchers from trying to bring medications
to market "will mean less opportunities to help patients with severe
illnesses," Dr. Schatzberg said, adding, "Drugs that are helpful may
not be developed by big pharmaceutical companies, for a variety of
reasons, and we need some degree of communication between academia and
industry" to expand options for patients.

Commercial arrangements are rampant throughout medicine. In the past
two decades, drug and device makers have paid tens of thousands of
doctors and researchers of all specialties. Worried that this money
could taint doctors' research plans or clinical judgment, government
agencies, medical journals and universities have been forced to look
more closely at deal details.

In psychiatry, Mr. Grassley has found an orchard of low-hanging fruit.
As a group, psychiatrists earn less in base salary than any other
specialists, according to a nationwide survey by the Medical Group
Management Association. In 2007, median compensation for psychiatrists
was $198,653, less than half of the $464,420 earned by diagnostic
radiologists and barely more than the $190,547 earned by doctors
practicing internal medicine.

But many psychiatrists supplement this income with consulting
arrangements with drug makers, traveling the country to give dinner
talks about drugs to other doctors for fees generally ranging from
$750 to $3,500 per event, for instance.

While data on industry consulting arrangements are sparse, state
officials in Vermont reported that in the 2007 fiscal year, drug
makers gave more money to psychiatrists than to doctors in any other
specialty. Eleven psychiatrists in the state received an average of
$56,944 each. Data from Minnesota, among the few other states to
collect such information, show a similar trend.

In both states, individual psychiatrists are not top earners, but
consulting arrangements are so common that their total tops all
others. The worry is that this money may subtly alter psychiatrists'
choices of which drugs to prescribe.

An analysis of Minnesota data by The New York Times last year found
that on average, psychiatrists who received at least $5,000 from
makers of newer-generation antipsychotic drugs appear to have written
three times as many prescriptions to children for the drugs as
psychiatrists who received less money or none. The drugs are not
approved for most uses in children, who appear to be especially
susceptible to the side effects, including rapid weight gain.

Senator Grassley's investigations have not only detailed how lucrative
those arrangements can be but have also shown that some top
psychiatrists failed to report all their earnings as required.

After The Times reported on such an arrangement involving Dr. Melissa
P. DelBello of the University of Cincinnati, Mr. Grassley asked the
university to provide her income disclosure forms and asked
AstraZeneca, the maker of the antipsychotic Seroquel, to reveal how
much it paid her.

In scientific publications, Dr. DelBello has reported working for
eight drug makers and told university officials that from 2005 to 2007
she earned about $100,000 in outside income, according to Mr.
Grassley.

But AstraZeneca told Mr. Grassley it paid her more than $238,000 in
that period. AstraZeneca sent some of its payments through MSZ
Associates, an Ohio corporation Dr. DelBello established for "personal
financial purposes."

The University of Cincinnati agreed to monitor those payments more closely.

In early June, the senator reported to Congress that Dr. Joseph
Biederman, a renowned child psychiatrist at Harvard Medical School,
and a colleague, Dr. Timothy E. Wilens, had reported to university
officials earning several hundred thousand dollars apiece in
consulting fees from drug makers from 2000 to 2007 when in fact they
had earned at least $1.6 million each.

Another member of the Harvard group, Dr. Thomas Spencer, reported
earning at least $1 million after being pressed by Mr. Grassley's
investigators. The Harvard psychiatrists said they took
conflict-of-interest policies seriously and had abided by disclosure
rules.

In late June, after Mr. Grassley singled out Dr. Schatzberg, Stanford
disputed some of the numbers in the report and has denied that Dr.
Schatzberg violated any research rules devised to police such
conflicts.

In an interview on Wednesday, Dr. Nada L. Stotland, president of the
psychiatric association, said the group had studied Mr. Grassley's
letter and Stanford's response and agreed with Stanford. Dr.
Schatzberg will take over as president of the association as planned,
she said.

"The larger issue here is that there's a revolution going on" in how
medicine handles industry money, said Dr. Stotland, a psychiatrist at
Rush Medical College in Chicago. "That's good, that's what we need,
and I believe we've been on the cutting edge of that revolution in
many ways."

Dr. Stotland said that the association began reviewing the income it
received from pharmaceutical companies last March, to identify
potential conflicts. Doctors and academic researchers generally worked
at arm's length from industry until the early 1980s, when Congress
passed the Bayh-Dole Act. This legislation encouraged closer
collaboration between researchers and industry to bring products to
market more quickly. The act helped foster the growth of the biotech
industry, and soon professors and universities were busy obtaining
patents and building relationships with industry.

Some psychiatrists have long argued that consulting with a company —
to help design a rigorous drug trial, for instance — benefits
patients, as long as the researcher has no financial stake in the
product and is not paid to speak about the drug to other doctors, like
a traveling pitchman.

Others say industry and academic researchers are now so deeply
intertwined that exposing doctors' private arrangements only stokes
suspicion without correcting the real problem: bias.

"Having everyone stand up like a Boy Scout and make a pledge isn't
going to quell suspicion," said Dr. Donald Klein, an emeritus
professor at Columbia, who has consulted with drug makers himself.
"The only hope to rule out bias is to have open access to all data
that's produced in studies and know that there are people checking it"
who are not on that company's payroll.

Studies have shown that researchers who are paid by a company are more
likely to report positive findings when evaluating that company's
drugs. The private deals can directly affect patient care, said Dr.
William Niederhut, a psychiatrist in private practice in Denver who
receives no industry money.

Dr. Niederhut said company-sponsored doctors had spread the word that
new and expensive drugs were better in treating bipolar disorder than
lithium, the cheaper old standby treatment.

"It's a sales pitch, and now it's looking like a whole lot of people
would have done better if they'd started on lithium in the first
place," Dr. Niederhut said in a telephone interview. "The profession
absolutely has to come clean on these industry deals, and soon."

Tighter rules, stronger statements and more debate may not make much
difference, if Mr. Grassley's findings are any guide. Universities
have rules requiring that faculty members disclose their outside
income so that conflicts of interest in research or patient care can
be managed. But some of the psychiatrists named in the investigations
apparently ignored the rules.

"I think we may be coming to a point where hospitals and medical
schools have to get serious about sanctioning," said Dr. Paul S.
Appelbaum, director of the division of psychiatry, medicine and the
law at Columbia. "You can suspend doctors' privileges, or suspend
their right to treat patients; both have a huge impact on income and
career. But if you're serious about these disclosure policies, you
have to be willing to back them up."



http://snipurl.com/2yodc

The dilemna of high cost and minimal benefit

The link below will take you to a New York Times article that discusses the cost and the benefits of Avastin. Avastin is a very expensive cancer drug.

The article does a good job of describing Avastin and the dilemna of having an expensive drug with limited benefits.

http://tinyurl.com/6443c5