Prostate Cancer Patients Denied Provenge: Fleming Sleeps Better

05/10/2007 07:18 AM |

Thomas Fleming, described my Matt Herper as a world reknown biostatistician who couldn't sleep the night of the FDA's Ad Comm vote on Provenge because he "knew" without randomized controlled trials the data on survival might be a fluke. Fleming wrote to Herper "Patients might drop out of the ongoing clinical trial in order to get the drug, not placebo. How, he asked, would that be good for prostate cancer patients?"

This is not a scientist writing, but a zealot trying to defend a religious position to himself by writing his Boswell. See Dendreon's Dilemma by Herper
http://www.forbes.com/home/sciencesandmedicine/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html


This does not justify the FDA's deadly decision to delay Provenge but it speaks volumes about the slavish mindset regarding clinical trials -- both inside and outside the agency and how to determine safety and efficacy. A bigger push to change the paradigm to evaluate personalized treatments -- of which cancer immunotherapies are a subset -- is needed.

That said, Fleming's publish confession of anguish reminds me of Cotton Mather who sought to unburden his soul after unleashing the Salem Witch trials. Don't give us this "I was doing it for the cancer patients." This is you protecting the probabilistic priesthood by offering up sacrificial lambs.

Sleep well.  Read More & Comment...

The National Institute for Economic Expediency

05/10/2007 06:56 AM |

I had posted an entry from Martyn Postle, Director, Cambridge Healthcare & Biotech in the how the UK did compared to the European countries on providing cancer care. I received a request to take down the post because CHB didn't want others -- or maybe just us -- to share it. Rather, it wants people to crawl their way to the site on their own.

Have it your way.  Read More & Comment...

Kenzi Klean Up

05/09/2007 12:54 PM |

The Senate just passed the FDA Revitalization Act, S. 1082, Final vote was: 93/1 -- with the one "Nay" vote coming from Bernie Sanders, the junior senator from Ben & Jerry's.

Some notable amendment wrap-ups:

Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.

Failed by a vote of 46/47

Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.

Failed by a vote of 47/47

Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.  Read More & Comment...

"Sicko" flops in test market trials

05/09/2007 08:56 AM |

Michael Moore's "Sicko" will roll out on June 29th.

Indeed, "roll out" is the right phrase. Can anyone take a film about health care from a clinically obese person seriously?

Well, obviously not.

Test-market screenings, according to inside sources, aren't going too well and the film's U.S. distributors (the Weinstein Company) may very well limit the marketing resources put behind the big man's latest pseudo-documentary.

Yawn.  Read More & Comment...

Bubba and the Dictators

05/09/2007 08:34 AM |

Bill Clinton stood alongside Thailand's dictator to announce his support of patent theft in Thailand and Brazil.  Read More & Comment...

Ad Hoc Advisory Attacks on Cancer Patients Continue

05/09/2007 08:06 AM |

So cancer patients should wait until Thomas Fleming and ODAC AdComm member Hussain thinks there are large enough trials to determine statistically significant benefit of survival to get medicines... It is the obsession with endpoints and large trials that is killing people with cancer as much as the disease itself. The only way to get answers is to either try these drugs in the real world or match these medicines to the most appropriate people with greater accuracy. We cannot do both using the methods Fleming and Hussain and old cancer order want to uphold. They claim they are protecting patients but patients are willing to take these medicines and participate in follow on studies that are scientifically sound.

How ODAC rules on the IDM immunotherapy will say much. It is time for Andy von Eschenbach to show some leadership on this and other issues of patient access, to show that there is a public health payoff to the Critical Path....

To see the level to which Fleming and Hussain have stooped you can go to www.cancerletter.com  Read More & Comment...

New Alzheimer's Disease Report Event

05/09/2007 07:37 AM |

New CMPI Report Presents First Estimates of the Potential Economic Impact That New Treatments for Alzheimer's Disease Could Have on the U.S. Economy

Who: ACT-AD and Alliance for Aging Research; The Center for Medicine in the Public Interest

What: New Report Launch: Press Conference and Lunch:

- New medication can stave off onset of Alzheimer’s, extending lives, saving money
- Report discusses ways to give more power to older consumers in an aging society

Where: National Press Club
529 14th Street NW – Washington, DC
Lisagor Room

When: Monday, May 14, 2007, 12:00 pm press conference and lunch

RSVP: Nicholas Terzulli, (212) 588-9148 / nterzulli@capitalhq.com

Speakers:

-- Meryl Comer, Alzheimer’sAssociation National Capital Area Chapter Board Member, and Emmy-award-winning reporter, producer, moderator; also the principal caregiverfor herhusband who has advanced Alzheimer’s.

-- Robert Goldberg, Ph.D.,Vice President and Director of Programs for the Center for Medicine in thePublic Interest.

-- Daniel Perry, Chair of theACT-AD Coalition and Executive Director of the non-profit organization Alliance for Aging Research.

-- Peter Pitts, President of Center for Medicine in the Public Interest and former FDA Associate Commissioner for External Relations

-- John Vernon, Ph.D., Assistant Professor in the Finance Department at the University of Connecticut School of Business.

About the Report

One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. Currently available treatments for Alzheimer’s disease provide only temporary symptomatic relief and only for some patients, while therapies under FDA review may significantly delay or reverse the course of the disease. This report presents the first scientific estimates of the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The report will also be posted and made available through the National Bureau of Economic Research.  Read More & Comment...

Does Congress suffer from RLS?

05/09/2007 07:02 AM |

That's "Reflexive Legislative Syndrome."

One possible patient is Senator Herb Kohl who is preparing a bill that would heavily restrict DTC advertising. Here's our read on the situation from The Wisconsin State Journal, the Cheesehead newspaper of record:

http://www.madison.com/wsj/home/column/other/index.php?ntid=132520&ntpid=5

If Senator Kohl is concerned about saving bucks -- he should look to the NBA.  Read More & Comment...

Evidence Based Migraines

05/08/2007 03:58 PM |

Another panel about what evidence should be used to make payment decisions and how studies should be structured...Medicine gets more complex and individualized and payors want simpler answers that are increasingly outdated. And we want to spend $5 billion a year on this?  Read More & Comment...

Sir Michael of NICE...Not so very...

05/08/2007 03:53 PM |

I was in the middle of asking a panel of Euro reimbursement experts including Sir Michael Rawlins who helped create NICE about whether the $50K per QALY was too low and even authoritative (since Sir Michael noted that the $50K per QALY had no empirical basis) when he announced he could not stay to listen to speech and walked out...

I guess what I had to say was not worth $50K per QALY  Read More & Comment...

Comparative Effectiveness EuroStyle

05/08/2007 01:54 PM |

The comparative effectiveness hurdle is firmly in place throughout Europe and it is all focusing on new drugs. And it is all one size fits all evaluations of whether or not there is improvement in actual benefit for drugs and benefit can be a matter of debate and deviation...and that is only the first part of the CE analysis. Then you have to demonstrate whether or not it is cost-effective

I find it interesting that health plans here that fought national health care have no problem importing the operating system of government medicine. The average time for a coverage decision is a year. Would health plans wait a year to get their premiums?  Read More & Comment...

They also serve who only stand and wait

05/08/2007 10:45 AM |

The quote is John Milton, but the practice is pure government health care.

Is this any way to treat a veteran... or anyone else for that matter ... like seniors on Part D?

Veterans filing disability claims with the Veterans Affairs Department wait for an average of almost six months for a response -- about six times longer than is typical in the private sector.

Pending disability claims with the VA take an average of 177 days to process, according to VA records. For some, the wait time is almost a year.

And for veterans appealing a decision on a claim, the average wait time is 657 days.

According to America's Health Insurance Plans (AHIP), for people filing disability claims with insurance companies, about 75 percent to 80 percent of claims are handled within 30 days. Federal law requires disability claims with private insurers to be settled within 45 days (although extensions of 30 days or longer are possible).

Here's the full story:

http://www.washingtontimes.com/national/20070508-122145-5910r.htm

Only in America does VA mean "stop."  Read More & Comment...

Certifiably Sane

05/08/2007 09:00 AM |

Bad news: Senator Byron Flickertail's ill-considered drug importation amendment was approved in a voice vote.

Good news: The Senate voted 49-40 in favor of an amendment from Senator Thad Cochran requiring certification from the Secretary of Health and Human Services that importation can be done safely.

That's something that Secretaries of HHS from both parties have never been able to do. Not Secretary Shalala. Not Secretary Thompson. Why? Because allowing medicines from outside our closed regulatory system into the legitimate American supply chain would lead to a safety nightmare. Also, according to multiple sources including the CBO, it would lead to insignificant savings.

Propaganda is one thing. Public health is another.

Talk about a no-brainer risk/benefit equation.  Read More & Comment...

Following Cato's Twisted Logic....Why Not Reimport Gasoline....

05/08/2007 07:29 AM |

Roger Pilon's Cato Institute still believes that using protectionist policies from other nation's is perfectly consistent with free market libertarian principles...maybe he can make the case for reinporting gasoline from the Saudis at highly subsidized prices to lower gas prices here.

http://biz.yahoo.com/cnnm/070504/050407_gas_demand.html?.v=1&.pf=family-home  Read More & Comment...

Bleak House 2007

05/07/2007 10:29 AM |

For those pols and pundits who think that we need a health care system "just like Europe," some harsh reality from the other side of the Pond.

The Observer (one of the leading liberal-left newspapers in Europe) reports that British doctors will take the historic step of admitting for the first time that many health treatments will be rationed in the future because the NHS cannot cope with spiraling demand from patients.

In a major report, the British Medical Association will warn that patients face a bleak future because they will increasingly be denied treatments. The BMA will urge the NHS to be much more explicit about what it can realistically afford to do and ask political leaders to engage in an open, honest debate about rationing.

Dr Michael Wilks, one of the BMA's senior office holders, revealed the organization’s radical thinking in a recent letter to its 139,000 members updating them on the progress of the BMA working group. He told them the group had concluded that '"while the service should remain universal, the challenges raise questions about how comprehensive the service can continue to be. This will depend on whether politicians and the taxpayer are prepared to contemplate either increasing expenditure or explicit rationing."

Here's a link to the Observer article:

http://observer.guardian.co.uk/uk_news/story/0,,2073633,00.html

Additional recommended reading includes Stephen Pollard's comments which can be found at http://cnehealth.org/  Read More & Comment...

Barack takes a BIO Break

05/07/2007 09:34 AM |

As BIO kicks off in Boston, so too does a new magazine, The Journal of Life Sciences. Check out the website at http://www.tjols.com.

Today the site features a commentary by Barack Obama. Here are a few select paragraphs ...

"We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not, and use this information to better prevent and treat disease."

"The relatively new field of genomics is key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient’s predisposition to a particular disease or condition."

"Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine."

"Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."

Here's a link to the entire piece:

http://www.tjols.com/web_new_frontier.jsp

If the Senator keeps this up, we may have to invite him to join our organization.  Read More & Comment...

And ALLHAT Jazz

05/07/2007 09:01 AM |

Recently Congress considered adding cost-effectiveness as a criterion for selecting and paying for medicines under Medicare.

This model (variously called “evidence-based medicine,” “healthcare technology assessment,” or "comparative effectiveness”) relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely if ever will tell us which treatments are “best” for which patients. That is why it is so critically important for the physician to maintain his or her ability to combine study findings with their expertise and knowledge of the individual in order to make the optimal treatment decisions.

Government sponsored studies that conduct head-to-head comparisons of drugs in "real world’"clinical settings are regarded as a valuable source of information for such coverage and reimbursement decisions -- if not for making clinical decisions. Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness or CATIE study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were two such “practice based” clinical trials, sponsored in part by the National Institutes of Health, to determine whether older medicines were as effective in achieving certain clinical outcomes as newer ones.

While media reports and the government agencies that sponsored the studies claimed that “older and cheaper” were equally effective, these conclusions were not without critics or controversy.

The Center for Medicine in the Public Interest held a day long conference on Media, Medicine and the Public Interest in Washington DC on January 26, 2007 that included an expert panel on the conduct and implications of CATIE and ALLHAT.

And when we say "expert" we mean "expert." Panelists included Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University, and Matt Herper of Forbes.

The panel was chaired by Kate Rawson, senior editor of th RPM Report, who also edited the panel transcripts.

Here is a link to the paper, ALLHAT and CATIE Reconsidered: Reflections on Big Studies and Evidence Based Medicine as the Measure of Comparative Effectiveness.

Download file

Thoughts and comments most welcome.  Read More & Comment...

whatever happened to zelnorm

05/04/2007 07:52 PM |

my column in M,M & M just out - with a fresh look at the scalded IBS drug -

For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ Zelnorm was a miracle treatment. But the current
focus on negative aspects of the drug has placed an unfortunate cloud over
its use.
What happened? A total of 29 placebo-controlled, 1-3 month trials of more
than 11,600 patients receiving Zelnorm showed a slight increase in the risk
of cardiovascular events‹angina, heart attacks and strokes‹over placebo
(0.1% versus 0.01%).
But these studies‹for the most part‹involved patients in higher risk groups
than those for whom myself and
others would prescribe it, and for some also a longer use
of the drug. Plus, many physicians were already aware of this potential
problem, which was why we gave the drug
mainly to younger people with lower risk for cardiovascular events.
The Food and Drug Administration acted quickly in its public advisory and
Novartis has agreed to stop marketing the drug and selling it in the US.
This is certainly a responsible and cautious reaction. So why aren¹t the FDA
and Novartis being praised for their actions on behalf of drug safety?
The answer is that we currently live in an unhealthy climate of drug company
bashing where every newly demonstrated risk is an opportunity for a new
round of criticism. Those who engage in this habit tend to justify it as a
way to protect society, though there is certainly a tradeoff‹excess caution
and fear of attack is certainly not conducive to research and development,
so don¹t be surprised if drug discoveries continue to decline.
It makes sense to keep Zelnorm in reserve for those in lower risk groups who
really need it. It also makes sense to not inflame the news of its slight
increased risk of heart disease and stroke and use it as a pulpit to start
criticizing everyone in sight.  Read More & Comment...

Dorgan's Double Standard

05/04/2007 08:59 AM |

From the Washington Times: "Mr. Dorgan's bill would implement an approval standard for foreign-made drugs in which the manufacturer notifies the FDA of differences between the drug and the corresponding U.S. label. "

Would Mr. Dorgan accept that as an approval standard for imported food as well?  Read More & Comment...

Rocky's Racoon

05/04/2007 08:06 AM |

Per Senator Rockefeller's opinion that we need to legislate branded generics out of existence, we are once again faced with the immutable Theory of Medicare Relativism — when politics wins, patients lose.

If the honorable gentleman gets his way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during the 180-day exclusivity period to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.)

The deliverable to the American patient? Higher prices and fewer choices. Needless to say, Rocky's “modest proposal” is being greedily embraced by the generics industry and Big Pharma bashers. And greedy is hardly hyperbole since profits on generic medicines exceed 45% even when there is a competitive branded generic on the market.

This is what we get for Medicare modernization? It’s Voltaire’s famous aphorism come to life, “The art of medicine consists in amusing the patient while nature cures the disease.” It would be far better if Senator Rockefeller followed the advice of Professor Einstein who said, “Any intelligent fool can make things bigger, more complex, and more violent. It takes a touch of genius — and a lot of courage — to move in the opposite direction.”

Here's a link to a new study providing more data:

http://www.genengnews.com/news/bnitem.aspx?name=16644361

It's either the facts or Rocky's Horror Picture Show.  Read More & Comment...