Wednesday, September 29, 2010

Menopause: The Scandal (Part Two)

In part one of this post, I introduced some of the admittedly controversial issues surrounding the use of hormone replacement therapy in menopausal women, and I pointed out that the proper forum for scientific debate and medical education is in journals and medical meetings. Furthermore, in order for us to trust the integrity of this education, it should not be funded by the pharmaceutical industry. Let drug companies fund research and advertising all they want--but scientific debate among doctors should be completely independent of a promotional agenda.

This sounds obvious but the current system of CME all too often turns a blind eye to what has become a constant stream of artful transgressions of this principal
. Journal supplements have become a key promotional strategy for drug companies seeking to influence prescribing behavior. This fact is hardly news, and such corrupted supplements are a dime a dozen to this day. What is unusual about Dr. Fugh-Berman's recent article about the marketing of Premarin is that she reveals a smoking gun--that is, documentation from Wyeth and DesignWrite showing that the CME was planned with an explicitly promotional intent.

The trail of evidence begins with a proposal for Wyeth submitted by DesignWrite, entitled "
Premarin Publication Program" (yes, the pdf is available from the Drug Industry Document Archive at UCSF, and it makes for pretty creepy bedtime reading). On page 3 of the proposal, DesignWrite tells Wyeth exactly what it plans to do in order to get more doctors to prescribe Premarin:

"The specific objective of this program is to 1) increase physician awareness on the multitude of benefits that hormone replacement therapy provides for postmenopausal patients, 2) diminish the negative perceptions associated with estrogens and cancer, and 3) blunt the competitive threat of raloxifene, a selective estrogen receptor modulator, expected to be approved early next year for osteoporosis."

Ghost-writing is big business. Wyeth paid DesignWrite $25,000 per Premarin-boosting article and ended up paying the company several million dollars between 1997 and 2003. They paid a particularly big chunk of cash, $413,140, for a CME meeting and journal supplement. DesignWrite apparently loves producing CME supplements for companies, because, as they say in their publication plan,

"The value of journal supplements is that it allows you to better tailor your marketing message since it is a manufacturer-sponsored publication form. Additionally, reprints of supplements may be purchased and distributed widely among health care professionals via sales representatives and direct mail."

DesignWrite put on a 2001 meeting of Wyeth's hired guns in order to provide content for the supplement. They helpfully produced this outline of what each article should say--basically, they all minimized concerns that HRT causes breast cancer.

Eventually, the supplement was published in 2001 by the journal
Women's Health in Primary Care and Wyeth mailed it to 128,000 physician, bought 1,500 additional copies for its sales force, and distributed the supplement to media and “select thought leaders”. In her article, Fugh-Berman publishes a pretty damning table comparing each carefully crafted marketing message with a corresponding sentence as it was published in a CME article. And of course, each article has an identified academic "author," with the actual writer having been an employee of DesignWrite in each case.

All in all, this is a nauseating example of the use of accredited CME to manipulate doctors.


petrossa said...

Living with a menopausal women i can definitively confirm that HRT gives a huge increase in quality of life largely worth the tiny (unproven causal) increased risk in breast cancer.

Correlation does not causation make, in other words breast cancer and hrt may be linked but noone has ever proven a definitive causal relation. And never will because that's inherently impossible since you can't weed out the myriad of factors that contribute to the getting of cancer.

The true scandal is that HRT isn't in the basic NHS's reimbursement to men and women alike.

SteveM said...

Re: "documentation from Wyeth and DesignWrite showing that the CME was planned with a explicitly promotional intent."

Danny, you are pointing at the wrong target. Why wouldn't Wyeth try to game CME content? They're in business to make money.

The root causes of the corruption are the doctors themselves. They edit the journals, they select contributors, they do the conference invites, they prescribe the drugs.

Doctors choose to be manipulated by choosing not to provide proper editorial oversight of CME content, not to sanction or censure peers who violate ethical norms and not to learn enough about the therapeutic pros, cons and alternatives of the drugs the prescribe.

All you docs have to do is have independent SME's review CME content before it can be validated for credit. They would send content back for rewrite if it's biased. Let the Pharma companies pay for the reviews. Problem solved.

How do I have this wrong?

Daniel Carlat said...

Petrossa--The point of my post is not to answer the controversial question of the strength of the relationship between HRT and later breast cancer. There are many reasonable physicians who would have different opinions based on their understanding of a vast literature. The point is that in this case an 800 pound gorilla with unlimited funds and a frankly promotional agenda has taken over the debate, and that is not only unethical, but terrible public policy.

Steve M--Docs are at fault, but so are lots of other stakeholders, including drug companies, MECCs, the ACCME, and the complicit medical societies. It would be nice if we could develop an organization of unbiased reviewers who could review all cme. But think of the logistics. There are many thousands of such programs produced yearly. The bias is so subtle as to be invisible to all but physicians who are hyperspecialized in the material being spun. Who is going to pay for thousands of doctors to take hours away from their practices to devote to reading this dreck?

Anonymous said...

The practices you identify here were from the time of, essentially no oversight after FDA Final Guidance, until 2003 when the OIG put teeth into the Phrma Guidelines. No one in Phrma has been operating this way for MANY years. And as you correctly point out- there was good reason to make these changes. But they have been made, and references to this type of historical activity has no place in todays discussion of improper influence unless that point is made. Is there a reason you dont acknowledge that these practices no longer take place?

petrossa said...

But such is life. From your local homeowners society to the white house pressure groups make/break policy.

It may be an 800 pound gorilla but it does feed a lot of mouths.

Furthermore 'just because i'm paranoid doesn't mean someone isn't following me'.

In other words, even 800 pound gorilla's can be right. They are not by definition wrong for weighing 800 pounds, nor is a 3 pound kittycat by definition right because it's cute as a button.

Obviously their purpose it to control the market, influence the public to buy their stuff. Which to most is good business sense.

It's like blaming Big Oil for the climate, WallStreet Traders for the economic crisis and the Israeli's for everything else.

As long as there is enough of a check and balance to prevent Big Pharma throwing to many deadly drugs on the market for too long a time we'll have to live with it.

My personal gripe is with GP's prescribing heavy duty drugs like candy. Statins, SSRI's are prescribed by GP's.

Getting Androgel prescribed, which actually does good, i had to cut every corner in existence. Absurd.

It's a bit too easy to say that's because they are brainwashed by Big Pharma. They are supposed to have a mind of their own.

Lili Velez said...

Trying to prevent all bias is a little like trying to find the magic antibiotic that will prevent bacteria from developing resistance in a few hundred generations. The attempt is worthy, but all solutions will need to be changed over time as the targets evolve in response.

I would be perfectly happy to run courses for interested physicians about how to create useful, accurate, and industry-independent CME. But they'd like to be paid for their time, and so would I. How do we get qualified people to decide educating each other is worth doing, when "free" materials are so easily available?