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March 31, 2008

Wowowow: Check It Out!

by Stephanie Koze

What do five female, media powerhouses have in common -- other than being female and media powerhouses? Wowowow.com. Check out this Web site for women 45+, newly launched by Mary Wells, Lesley Stahl, Peggy Noonan, Liz Smith and Joni Evans.

Together with their esteemed friends, among the likes of Candice Bergen, Whoopie Goldberg, Marlo Thomas, Sheila Nivens and several other distinguished partners, these ladies are providing insights and points of view regarding the latest world events and current social issues. Think along the lines of The View for the Web.

In addition to learning about their perspectives, you can post your thoughts. Don't forget to participate. Let's keep this site alive.

Posted by stephanie_koze at 01:29 PM
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And some people think patients need less information?

by Peter Pitts

Many Women Unclear About Breast Cancer Treatments

MONDAY, March 31 (HealthDay News) -- Only half the women diagnosed with early-stage breast cancer clearly understand the risks and benefits of a mastectomy versus a breast-conserving lumpectomy plus radiation, even after they have one of the procedures, according to a new study.
If the woman is black or Hispanic, the chances are even less likely she has adequate information, say researchers whose results appear in the latest online issue of the journal Health Services Research.

The study looked at 1,132 women from Detroit and Los Angeles who had undergone surgery for ductal carcinoma in situ or invasive but not metastatic breast cancer. The women reported their race and ethnicity, knowledge of survival and recurrence, and cancer topics they had discussed with their surgeons, who also were surveyed.

Only 51 percent of women in the study knew that patients who had a mastectomy or a lumpectomy plus radiation had the same five-year survival rate. Forty-eight percent of the women reported not knowing whether cancer recurrence rates were the same for mastectomy as they were for a lumpectomy with radiation.

The survey also revealed that black and Hispanic women were less likely to know about breast cancer survival and recurrence, as were older women and those with less education.

"Overall, women were not generally well-informed about the risks and benefits of the treatment they received," study lead author Sarah Hawley, a research assistant professor at the University of Michigan Health System and research investigator at the Ann Arbor VA Healthcare System, said in a prepared statement.

Women who said their surgeons discussed both treatment options did know more about survival and recurrence rates, but minority women still lagged in survival and recurrence knowledge, Hawley said.

"The authors' finding of racial and ethnic differences in knowledge of survival and recurrence according to surgical treatment are concerning because of their implications about possible suboptimal communication between surgeons and their ethnic minority patients," Dr. Leah Karliner, an assistant professor of medicine at the University of California, San Francisco, who was not affiliated with the study, said in a prepared statement.

However, Karliner said the findings are only associations, and readers can't draw cause-and-effect conclusions about the results.

For women facing breast cancer treatment, they should always ask all of their questions before deciding on a treatment option and make sure they understand the reasons behind their doctors' recommendations for or against a particular treatment, Karliner said.

Posted by peterpitts at 10:28 AM
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Just what we need, an even Dentzer Health Affairs

by Peter Pitts

No, really.

Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.

“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,” Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.

Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.

Good luck Susan.

Posted by peterpitts at 08:27 AM
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March 28, 2008

Claire and Present Danger

by Peter Pitts

Senator Claire McCaskill (D, MO) thinks that the FDA’s draft guidance on off-label communications is "a startling potential change in policy.”

Um, no.

Someone should point out to the Senator that the “policy” that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.

So much for the “startling change of policy.” (Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)

Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change” is "intellectually dishonest or evidence that they are ignorant of the legal context.”

Ouch.

Posted by peterpitts at 08:15 AM
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March 27, 2008

Follow-on, Oh Canada

by Peter Pitts

Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.

Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.

Posted by peterpitts at 08:08 AM
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March 25, 2008

Failed Drugs or Failed Pathways?

by Peter Pitts

Interesting article in the Wall Street Journal on the use of genetic tools to resuscitate failed compounds.

Here how the story begins:

“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.

The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.”

And here’s the rest of the story:

http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief

The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).

Sound familiar? Correct – the Critical Path.

Posted by peterpitts at 09:01 AM
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March 18, 2008

Caught in in FDA's Web

by Peter Pitts

FDA's new website that is.

Check it out at http://www.fda.gov

Posted by peterpitts at 04:43 PM
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March 17, 2008

How many economists does it take to screw in a lightbulb?

by Peter Pitts

If the lightbulb is meant to shine a light on the value of new healthcare-related technologies in the context of healthcare technology assessment (HTA) -- then the answer is "one."

And the "one" is Dr. Frank Lichtenberg of Columbia University.

According to Frank, for HTA to yield valid decisions in practice, it is necessary to have reliable estimates of:

ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)

And his main point is that the devil is in the details.

He believes that incorrect estimates of some or all of these key inputs are often used:

ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated

And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.

Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.

Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:

Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States

Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.

and

Murphy and Topel: The value of a life year is $373,000.

Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.

Attention must be paid. Hello NICE. Hello IQWiG. Hello Senators Baucus and Conrad.

If the devil is in the details (and it is) -- it's time for a deep dive beyond simplistic and self-serving "comparative effectivess."

Posted by peterpitts at 08:55 AM
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March 10, 2008

Verifiably Inane

by Peter Pitts

What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?

For a complete answer, see here.

And for an insight into regulatory creep, consider this little codicil:

"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."

This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.

After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.

Verifiable? How about verifiably inane

Posted by peterpitts at 07:08 AM
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March 03, 2008

Embed with the FDA

by Peter Pitts

Some comments from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.

Star of the meeting was FDA Commissioner von Eschenbach.

Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."

The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."

Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.

"Help us dialogue," the Commissioner asked the committee.

Communications hint to Commissioner: "Dialogue" is not a verb.

To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.

He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.

Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.

The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.

Amen again-- and God's Speed.

Posted by peterpitts at 08:21 AM
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