LA Supplemental

03/23/2007 01:36 PM |

Today's New York Times editorial page thinks that the FDA should be 100% funded by legislative appropriations. Here we go again.

First, a correction that you will not see in the Gray Lady:

The Times writes that PDUFA fees “help finance the approval process …”

True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.

So what’s the big deal where the money comes from? Two big reasons:

(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.

(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the “drug-lag?” Yes, folks – it was real.

And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agency’s critics that, if only the FDA worked harder, they could replace “conflicted” advisory committee members with ones equally talented and more pure.

Malarkey.

Ladies and Gentlemen – mediocrity is not an option.

When legislators try to rewrite history we suffer the inevitable consequences.  Read More & Comment...

Marc Siegel MD...The Importance of Early Detection in Treating Cancer

03/22/2007 10:28 PM |

The first post of our new CMPI fellow ... Marc Siegel MD

The spread of Elizabeth Edwards cancer may provoke the public to many reactions: sympathy, empathy, worry. Surely, we all hope that this unfortunate event won't be grounds for either political gain or loss. Surely, we all hope that any public discussion of cancer spread will be grounds for more cancer awareness and prevention and treatment advances.

It was just last week that I wrote an oped in the WSJ about the importance of diagnosing lung cancer before it escapes the lung. I pointed out the need for effective use of technologically advanced CT scanning for this to happen.

I mentioned breast cancer as an example of another cancer where early detection was important for reduced morbidity and lifestyle advantage, if not survival.

Of course breast cancer is generally not as aggressive and is somewhat more responsive to chemotherapy.

But what Mrs. Edwards case points out is just how treacherous the disease is, and just how expensive and emotionally costly treatments for advanced cancer are.

Metastases to the bone, as Mrs. Edwards has sustained, tend to be somewhat amenable to chemotherapy, so that if not a cure, at least this patient can hope for a long term remission and an effective and happy life.

I do not know the details of Edwards' case, or how it was diagnosed. As we all hope for the best outcome for this public figure, I can't help but hope that many other women have their cancer caught as early as possible, whether by mammogram, or breast exam, or by whatever MRI technology becomes more accessible and useful for breast screening. While we hope for the longest life possible for Mrs. Edwards and those like her who suffer from metastatic cancer, we also hope that expensive treatments for metastatic disease can be avoided as frequently as possible as the result of advances in techniques of early detection.

Marc Siegel MD

Dr. Siegel is a prolific writer, an Associate Professor of Medicine and a Fellow in the Master Scholars Society at New York University School of Medicine, a columnist for the Los Angeles Times, a frequent contributor to the Washington Post and Family Circle. He is a member of the board of contributors at USA Today. He appears frequently on CNN, the Fox News Channel, and the NBC Today Show.


Dr. Siegel's "False Alarm: The Truth About the Epidemic of Fear" has been named one of the "Top Science Books of the Year"  Read More & Comment...

Medicare Miasma

03/22/2007 04:28 PM |

A taste of the stale debate about Medicare that took -- and will take place -- in Congress. I am so glad I have HBO...

Senator Jon Cornyn sponsored an amendment that would make high income Medicare beneficiaries to pay higher premiums for prescription drugs. It went down in flames.

Not before it got doused by with rhetorical kerosene by Democrat Sen. Sherrod Brown who claimed that Republicans "come to the floor of this chamber ... over and over, from every different direction they attack one of the single greatest programs that this government has ever done."

As opposed to shoving every senior into a VA or Canadian style drug program Senator?

How about enlisting seniors, doctors and others to save Medicare money by not using services and staying healthy? We have taken some steps in that direction but I fear that we are not going to get much traction with Democrats in control...  Read More & Comment...

COI Opaqueness

03/22/2007 07:35 AM |

Why is it that only some groups need to be transparent? In many of today's news reports on the FDA's new draft guidance on advisory committee conflict of interest some groups are deemed "consumer advocates" -- but no mention is made of their funding sources, while other organizations are quoted, but tagged "industry funded."

Why is this?

For example:

http://www.baltimoresun.com/news/nationworld/bal-te.fda22mar22,0,763576.story?coll=bal-home-headlines

A good story by a solid reporter -- but shouldn't there be transparency for all concerned?

Isn't that the point?  Read More & Comment...

Disclosure Cuts Both Ways and Will Cut the Heart of the FDA Advisory Committee Process

03/21/2007 12:40 PM |

How about a $50K cap for anyone who has taken money a legal expert in a plaintiffs suit or as a consultant thereof or has received a cut from a personal injury or product liability suit. How about anyone who has received large grants from private foundations or government in excess of that amount?

My prediction: just as you saw an exodus of the best and brightest from the NIH as a result of a restrictive and hyper-reactive cap on consulting to crack down on the appearance of the appearance of a conflict, the same will happen with Advi Comms at the FDA. You will get mediocre, unmotivated or ideologically driven researchers populating committees and using the proceedings to promote their particular positions.

http://online.wsj.com/article/SB110980263395968693.html  Read More & Comment...

A Knee to the Kidney (Foundation) From the NYT

03/21/2007 12:34 PM |

Another smear job on another servant of the public health, Allen Collins, as head of the National Kidney Foundation as part of a INDEPENDENT group of experts developed guidelines to develop EPO levels to a point where people on dialysis lived longer and better lives.

Somehow that never got into the smear job Gardiner Harris did on him...

http://www.nytimes.com/2007/03/21/us/21drug.html?ei=5087%0A&em=&en=1b7a123ccba022cd&ex=1174622400&pagewanted=print

In case anyone is interested in a real contribution to the public health, here a link to the work undertaken by Dr. Collins

http://www.kidney.org/PROFESSIONALS/kdoqi/nkfAdvisory.cfm  Read More & Comment...

Feeling Conflicted?

03/21/2007 12:32 PM |

Here is the link to the relevant documents:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html

If you are conflicted (either existentially or actually), I grant you a waiver to view these materials.  Read More & Comment...

New FDA Draft Guidance on Adcomm COI

03/21/2007 11:19 AM |

I am currently listening to an FDA stakeholder call on a new draft guidance for FDA advisory committee conflict of interest.

Rather than "in" or "out," the agency is suggesting three options:

(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.

The FDA did not define what "some" means.

(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.

It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).

(3) If a panel member has the "appearance" of a conflict they may be recused.

No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.

More as more develops.  Read More & Comment...

Medicare Advantage

03/21/2007 11:04 AM |

Want the facts and nothing but the facts on Medicare Advantage?

Of course you do, you're a drugwonk!

Have a look at this document:

Download file

CMPI is glad to have assisted in putting this fact sheet together.  Read More & Comment...

FDAMAmia

03/21/2007 10:04 AM |

Here's a link to the complete BioCentury feature, "Deconstructing FDAMA."

Download file

Many thanks to Bard Steve and BioCentury for the permission to share.  Read More & Comment...

The Road to Perdition

03/21/2007 09:11 AM |

Steve Usdin certainly has a way with words. Consider these pearls from the recent edition of BioCentury:

"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.

The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.

Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.

The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.

But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."

We hereby dub Sir Steve the "Bard of BioCentury."  Read More & Comment...

Waxman Pushes Access to Medicines Over Safety

03/20/2007 07:41 PM |

Henry Waxman supports a bill that would limit the FDA's control over the distribution of pot for medical purposes less than it would limit a doctor's use of new medicines that undergo FDA approval.

Here is the relevant portion of the States Right to Medical Marijuana Act

FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) In General- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict--

(1) the prescription or recommendation of marijuana by a physician for medical use,

(2) an individual from obtaining and using marijuana from a prescription or recommendation of marijuana by a physician for medical use by such individual, or

(3) a pharmacy from obtaining and holding marijuana for the prescription or recommendation of marijuana by a physician for medical use,

in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.

(b) Production- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict an entity established by a State, in which marijuana may be prescribed or recommended by a physician for medical use, for the purpose of producing marijuana for prescription or recommendation by a physician for medical use from producing and distributing marijuana for such purpose.

Compare that to the civil penalties handed out to anyone violating any aspect of any risk management plan doled out by the FDA under Waxman's watchful eye,



Waxman said of those who opposed a bill to give states the right to regulate the use of marijuana for medical purposes: They "think we should just say no to sick and dying patients because it looks like we're getting tough on drugs."

Is that like saying no to sick and dying patients because it looks like we are getting tough on drug safety?

PS. See the following article

High School Students Getting Medical Marijuana Cards In California

Some California teens are giving a new meaning to "high" school.

Students are finding easy access to medical marijuana cards and presenting those cards to school authorities as a legitimate excuse for getting high.
Advertisement


But, where are the cards coming from?

A letter was sent home to parents of students in the Grossmont Union High School District.

"It's not a get out of jail free card at all." Catherine Martin says even though medical marijuana is legal in California, the law doesn't apply to schools which are subject to federal law. The district also says the students most recently suspended for being high with cards in hand - didn't have major illnesses.

"Students are getting them for things like sleeplessness and stress - it just draws into question how easy is it for people to get their hands on these cards."

Well, at least they are not promoting off-label drug use....

http://www.ksdk.com/news/news_article.aspx?storyid=114394  Read More & Comment...

Mark "Subtle Hint" McClellan

03/20/2007 03:21 PM |

Mark McClellan in this week's BioCentury:

"When you have an adverse event reporting system that only captures about 10% of events, that does it with variable time lags, and with inconsistentely collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern."  Read More & Comment...

Anger Management

03/20/2007 10:18 AM |

After reading Daniel Costello's article in the LA Times "Setting a Price for Putting Off Death," I fired off an angry letter to him basically accusing him of favoring rationing and of being heartless.

He called me back and let me have it. I deserved it and he deserved better.

The article is excellent. And it raises an important question about whether our health care system is designed to invest in life or not. More important, I might be upset that some people might think about putting a price on life but I was way out of line.

http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?page=2&track=rss  Read More & Comment...

Frank and Sense

03/20/2007 09:59 AM |

Frank Burroughs that is, of the Abigail Alliance.

Frank called me yesterday to discuss an article in the March issue of Medical Marketing & Media entitled, "Are NDA Laws Constitutional." He felt that my comments were used to undercut the policy position of the Abigail Alliance.

So I went back to the article and, although I stand by every single one of my quotes, Frank is right in pointing out that the context in which they were used could lead you to think I fundamentally disagree with his position on the issue.

Not so. Not at all. And I feel it's important that I make this point without any ambiguity.

Here is a link to the article:

http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=428

That's good for Frank. And it's good sense.  Read More & Comment...

Congress Forgets About the 5 Million With Alzheimer's

03/20/2007 09:27 AM |

http://news.yahoo.com/s/ap/20070320/ap_on_he_me/alzheimer_s

Latest estimate of people living with Alzheimer's is up to 5 million. Meanwhile as Steve Usdin's excellent piece in Biocentury demonstrates, the FDA Modernization Act of 1997 has done nothing to accelerate the pace of bringing new drugs to people.

Which is why the FDA pushed for Critical Path

Meanwhile Congress ignores the growing Alzheimer problem. Indeed, it seems determined to make it worse. It fiddles with making the FDA decision making process longer and more expensive and so-called medical experts flush with money from junk science litigation about silicone breast implants (defendscience.org) claim that user fees have made more people less safe. (Without any evidence to back it up, but what else is new?) These same people also want follow on biologics to flow like tap water free from the same safety standards they would impose on old medicines.

On a related subject,even if a new drug for Alzheimer's was approved and it cost $10000 a year to stave off onset by 1-3 years, my guess is that the media would question whether medicines that don't cure such a disease are worth it. Don't believe me? Just look at the piece of garbage Daniel Costello of the LA Times wrote about cancer drugs this past Sunday. He basically asked if 3 months of life is worth $40k?

Let him cut short his own life and family to save some cash before he makes that decision for society.

http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?track=rss
By LAURAN NEERGAARD, AP Medical Writer Tue Mar 20, 6:51 AM ET

WASHINGTON - More than 5 million Americans are living with
Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago — and a count that supports the long-forecast dementia epidemic as the population grays.



Age is the biggest risk factor, and the report to be released Tuesday shows the nation is on track for skyrocketing Alzheimer's once the baby boomers start turning 65 in 2011. Already, one in eight people 65 and older have the mind-destroying illness, and nearly one in two people over 85.

Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.  Read More & Comment...

Nice but not Necessary

03/20/2007 08:35 AM |

From the current edition of FDA News ...

Experts Question Effect of FDA's New Office of Integrity and Accountability

by Christopher Hollis

FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).

The initiative is just "placating critics on Capitol Hill" and could divert resources away from the FDA's mission, Pitts noted. It is wrong for politics to drive agency policy, Pitts said.

Von Eschenbach announced the creation of the new office during PhRMA's annual board meeting March 15.

However, CMPI Vice President Robert Goldberg said that the creation of the office was a good move for the FDA. "I think what von Eschenbach is trying to do is bring some order to the frat house."

"What he is doing, I think, with this office is giving people who have a grievance or feel that they've been side-stepped an opportunity to . vent and formally present their case to the commissioner, instead of having it fester as some kind of internal squabble within the ranks." That's a smart idea, he added, "and the right thing to do, rather than taking it to Congress where the data and the claims go unfiltered right to the media."

One of the issues the new office will handle is managing conflicts of interest for advisory committee members. Pitts, who dealt with advisory committee issues while serving during the first term of the Bush administration as the FDA's associate commissioner for external relations, noted that restrictive policies regarding conflicts of interest for committees are not conducive to retaining the best and the brightest scientists.

Instead of the best and the brightest, you get "almost the best and kind of the brightest," Pitts said. Goldberg echoed Pitts' sentiment regarding restrictive conflict of interest policies, specifically those set forth by the Institute of Medicine and in S.484, the "Enhancing Drug Safety and Innovation Act of 2007," introduced by Sens. Edward Kennedy (D-Mass.) and
Mike Enzi (R-Wyo.).

"It's ridiculous. People who have won Nobel prizes in pharmacology or medicinal chemistry would have been excluded [as members], both by the recommendations made by the Institute of Medicine and by the standards set forth in [S.484]," Goldberg said.  Read More & Comment...

Buddying Up with the Amigo Society

03/19/2007 03:28 PM |

May I recommend Unlocking Ideas: Essays from the Amigo Society.

Edited by Francesca Ficai; Introduction by Jacob Arfwedson; Arne Björnberg; Manuel Campolini; Pat Cox; Brian Crowley; Duncan Curley; Johan Hjertqvist; Pavel Hrobon; Johnny Munkhammar, Peter Pitts, Jan Remans, Anders Sandberg.

The Amigo Society conferences, held in Brussels, were set up in 2004 to bring together public policy experts, media representatives and members of civil society to debate these and other issues of importance to an enlarged Europe.

Taking concrete examples from all over Europe and North America, this collection examines the broad motivations behind, influences on, and opportunities for future health and welfare policy reform. It also looks to the future – drawing in new fields of policymaking such as biotechnology, tailormade medicines and other technologies expected to drastically alter Europe’s healthcare landscape.

And driving it all, the final set of essays examines consumer empowerment as the major factor which will push forward reform of Europe’s health and welfare systems.

The book can be found at:

http://www.stockholm-network.org/publications/list.php#75

Unlocking Ideas: Essays from the Amigo Society assembles the highlights of these debates over the past two years and provides exciting new insights for the reformers of the future.  Read More & Comment...

SKAPP, rhymes with ...

03/19/2007 01:16 PM |

conflicts.

According to its website -- defendingscience.org -- The Project on Scientific Knowledge and Public Policy examines the nature of science and how it is used and misused in government decision-making and legal proceedings. Through empirical research, conversations among scholars, and publications, SKAPP aims to enhance understanding of how knowledge is generated and interpreted. SKAPP promotes transparent decision-making, based on the best available science, to protect public health.

It receives its funding from the huge settlement awarded by bankrupting Dow Corning during the silicon breast implant litigation.

Can anyone say junk science?

Marcia Angell can and did. She wrote a book called Science on Trial about how science was hijacked by David Kessler and the FDA at the time. Kessler held another advisory committee hearing with non-experts on autoimmune disorders to get the scary results he wanted on about the risks of implants when the first one upheld their safety.

SKAPP just issued an open letter decrying the use of user fees to fund FDA operations.

It was signed by Arnold Relman, husband of Marcia Angell.

It was also signed by a handful of the members of the IOM panel that wrote the drug safety report. So much for objectivity.

It includes Bruce Psaty who has shown David Graham how to twist claims data to scare people. Psaty once claimed that post-menopausal women using calcium channel blockers had a 150 percent increased risk of breast cancer.

But the study was small and, as stated in a National Institutes of Health press release, "the findings do not establish a causal link between calcium channel blocker use and breast cancer." Moreover, the study conflicts with results of SYST-EUR, a recent long-term clinical trial of CCBs that did not reveal any increased cancer incidence.

The Cancer study is just the latest in a series of CCB-scares manufactured by Dr. Curt Furberg of Bowman Gray Medical School -- another co-signed or the letter and oft-time cohort Dr. Bruce Psaty of the University of Washington. Their first scare linked CCBs with increased heart attack risk. But the evidence was so shoddy that Dr. Psaty was forced to apologize to colleagues at the American Society of Hypertension for launching a scare based on a single study with serious limitations.

As for Furberg, he was chair and principal investigator of the ALLHAT trial. He designed the trial. In so doing, he guaranteed that African Americans would be more likely to die during the study comparing different types of blood pressure durings and their impact on heart attack. As Michael Weber, who was on the ALLHAT steering commitee noted: "One factor that drove the ALLHAT conclusions more than anything else was the unexpected 15% higher stroke rate in patients treated with the newer ACE inhibitor drug as compared with the diuretic. But, on close inspection, it turned out that this result was due entirely to a 40% excess stroke rate in black patients. In fact, well before ALLHAT, it was known that blood pressure in African Americans responds poorly to ACE inhibitors, so that the excess stroke rate in these patients was not only predictable, but also highlights the ethical issue of exposing these patients to the high risks of an inappropriate treatment.

Even Furberg has publicly acknowledged that white patients do at least as well on ACE inhibitors as on diuretics, perhaps somewhat better according to an even more recent trial published in the New England Journal of Medicine.

Susan Wood is part of SKAPP and signatory to the letter as well. She was head of the Office of Women's Health at the FDA (She is a PhD, like me, not an MD) Rather than stay and fight for women's reproductive rights at the FDA or help the FDA inform young women about HPV after the launch of the most important vaccine for woman's reproductive health in human history, she left to run SKAPP using money from a slush fund created through questionable science and manipulation of databases.

According to SKAPP

"Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation, with additional support from the Alice Hamilton Fund and the Bauman Foundation. The opinions expressed on the DefendingScience website are ours alone. SKAPP's funding is unrestricted. We do not provide our funders advance notice or the opportunity to review or approve the content of this site or any documents produced by the project."

That's fine. I really don't care where they get their dough and it's not an issue as long as they don't make where other people get their money an issue.

The same goes for the editors and producers of new organizations: just serving notice to the media that fails to report any of this but notes that CMPI receives funding from pharma or bio concerns. Transparency cuts both ways.  Read More & Comment...

The Side Effects of Side Effects

03/19/2007 07:42 AM |

Here's an interesting article from Medical Marketing & Media, with many good interviews (Dan Troy, Scott Gottlieb, Steve Galson, Andy von Eschenbach, Dan Carpenter, Sheila Burke, etc.), on the timely question, Wither PDUFA?

Voila la link ...

http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[sword]=warren%20ross&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=422

Worth a look.  Read More & Comment...