How Transparent Should the FDA Be?

01/15/2008 02:39 PM |

I took Senator Grassley to task for suggesting that unhappy reviewers and other malcontents air the grievances and differences with FDA division decisions at AdComm meetings a while back. Now from the other side, people and companies who complain about the lack of consistent or guidance from the FDA regarding the reason for holding up an approval also want transparency.

Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.

What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx  Read More & Comment...

The Heart of the Matter on Vytorin

01/15/2008 02:26 PM |

While lots of folks are making much ado about whether or not to readjust the athero endpoint of the Vytorin study because of hard to read ultrasounds (remember Steve Nissen and Atherogenics?) the the results of the study demonstrate, once again, just how hard it is to use statins to get reversal of plaque. We need better drugs. Good article from cnn.com on what the study shows and don't. Ignore the Congressional witchhunt threats and the whining of the "Kill Pharma Even If People Die" bloggers...

http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm  Read More & Comment...

The Born Identity

01/15/2008 01:42 PM |

My book review of Embryo: A Defense of Human Life...

http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm  Read More & Comment...

Contempt for Pharmaceutical Companies: The Right Stuff for Being President?

01/15/2008 01:09 PM |

Here are two of the qualities Leon Wieseltier in The New Republic like about about John McCain that make him a nearly ideal presidential candidate. "anxiety over the environment and contempt for pharmaceutical companies."

Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?

I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know.  Read More & Comment...

Dear Abby: No Comment

01/15/2008 10:07 AM |

The U.S. Supreme Court has, without comment, opted not to accept an appeal of Abigail Alliance v. von Eschenbach. This means the federal appeals court ruling that patients do not have a constitutional right to experimental drugs stands.

This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.

That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.

The question is, how to do so with greater alacrity and responsible, robust oversight.

When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.

That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.

We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.

And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.  Read More & Comment...

Fibromyalgia? What would Hillary say?

01/14/2008 08:52 AM |

Page One story in today's New York Times continues the debate over whether or not fibromyalgia is a "real" disease. After all -- it's just a "women's problem," right?

Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.

But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.

“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,” Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.

Nonsense. What would Hillary say? Someone should ask her about this during the next debate?

At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record?  Read More & Comment...

Insta-Americans: The Television Show

01/14/2008 07:46 AM |

Click here:

http://www.kvue.com/video/index.html?vid=207443

Then look under "HealthVue Video: Experts: Know where your health info comes from."

And we do.  Read More & Comment...

Jonathan Swift, meet Werner van den Gobbledygook

01/11/2008 07:55 AM |

For those of you watching EU policy on information to patients (“ITP” in EU parlance), there are two documents worth discussing.

The first is “Communication from the Commission to the European Parliament and the Council Concerning the Report on Current Practice with Regard to Provisions of Information to Patients on Medicinal Products’

(I know, it sounds like the title of a Jonathan Swift essay)

I quote directly:

“The provision of information on medicinal products requires taking into consideration the needs of patients in the context of healthcare provision.”

Once you get past all the banal bureaucratic gobbledygook, there’s some pretty interesting bureaucratic gobbledygook.

(Is there someone somewhere in a secret, secure location in Brussels named Werner van den Gobbledygook who edits all these EU documents?)

“Most sources available point to the increasingly active role of patients in this regard; patients have a right to be informed and in this context they should be able to access information about their health, medical conditions and the availability of treatments.”

A crucial point – but if the delivery of information is placed in the hands of governments (aka "payors") – will “availability of treatments” be defined as “what will be reimbursed” or will the full panoply of options be presented to newly empowered European patients? This is not just a finesse question, but rather hits at the heart of the matter. He who controls the access to knowledge controls the knowledge.

“Patients are no longer simply taking what is prescribed for them, but are increasingly involved as manager of their health. They become intensely involved with their illness, show great interest in health issues and have a constantly growing need for information.”

This is an elliptical way of saying that, when patients learn that they are being denied treatment because of cost-based vs. patient-centric government care schemes, they get upset – very upset.

And finally, “Recent evidence indicates that patients are however often unsuccessful in playing a larger role in their health decisions.”

Even though government health care limits, by definition, many health care options, the lack of information adds to that dilemma. According to the report, “Although there is insufficient evidence published, an increase in the quality and appropriateness of information available to patients would be expected to contribute to achieve better health conditions and also to contribute to a more efficient use of resources. Better informed patients are expected to adhere better to treatments and to better understand clinical decisions. This should lead in the long term to social and economic benefits.”

That’s right. And, once you plod your way through all the conditional phrasing, the report is saying that more information results in better outcomes which reduces costs. Amen. But when they say there is “insufficient evidence,” what they’re really saying is that there’s actually a lot of solid research – except that it pertains to the positive benefits of direct to consumer advertising. But at least they’ve embraced the concept that more information is better.

Unfortunately the report also calls for the EU to “keep the ban on direct to consumer advertising on prescription-only medicines.” (For more on this point, please see “Will Brussels DTC the Light?" at http://drugwonks.com/2006/10/will_brussels_dtc_the_light.html.) But that's another issue for another time.

Towards the end of the report, this refreshingly honest statement:

“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals throughout the EU.”

So much for Health Action International (HAI) who claims, “There is no health information gap in Europe.”

And then there’s the companion document, “Commission Staff Working Document: Background information supportive to the Communication from the Commission to the European Parliament and the Council concerning the Report on Current Practice with Regard to Provision of Information to Patients on Medicinal Products, in the form of different annexes”

(Indeed, the titles just keep getting sexier, pithier, and more lyrical).

Again, I quote directly:

“Pharmaceutical companies possess key information about their products which only in part (through leaflets and labels) is made available to the public. Consequently, the pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.”

And, “Like many patient organizations most pharmaceutical companies argue that information should be of high quality and not be judged by its source. These companies want to be able to produce non-promotional information for patients about their own medicines and diseases and make it public.”

EU Commission recognition that the pharmaceutical industry can be a valuable partner in the broader dissemination of timely and accurate health care information is an important step in the right direction.

And it’s about time because, as Julian Morris of the London-based International Policy Network quipped, “Europe is running out of failed alternatives.”  Read More & Comment...

When You Have Nothing Nice To Say

01/10/2008 04:23 PM |

We are used to the usual beside the point rejoinders when people disagree with us. I'm linking to this particular one because, well, it's so feisty and original. At least Dr. Poses actually read what I wrote and responded substantively. Like calling me a tool of Big Pharma. And we had a meeting of the minds on comparative effectiveness. Oh well.

Here's the post below...

http://hcrenewal.blogspot.com/2008/01/sceptical-look-at-dire-warning-is.html#links

That health care in the US is now in a crisis is now a cliche. Finding our way out of this crisis requires logical discussion based on evidence, not half-truths and irrelevancies promulgated by people with hidden financial ties.

What does promulgated mean? Is that how you get MRSA?  Read More & Comment...

ATLA Shrugged

01/10/2008 02:31 PM |

The organization formerly known as the Association of Trial Lawyers of America (ATLA) -- the NewSpeak-named American Association for Justice -- doesn’t like our study on the dangers of Internet health care information.

We must be doing something right.

According to the president of the association, Kathleen Flynn Peterson, “How can anyone take these groups seriously when they release studies based on a methodology of Google searches?”

Kathy -- it was a study about Internet searches. Google -- get it?

Since we're asking questions, here's one for Ms. Peterson -- Why are tort lawyers masquerading as health care advocates on Google in the first place?  Read More & Comment...

Autism is a Genetic Disorder

01/10/2008 10:26 AM |

The recent article in the NEJM has the results of a carefully researched genomic analysis that included scientists from several institutes. The study was elegant -- comparing families and children with autism spectrum disorder (all independently adjudicated) with controls that did not along with those that had a bipolar diagnosis and therefore shared a genetic duplication and deletion on Chromosome 16p11.2 The analysis was run a three platforms and cross referenced to assure inter-reliabiity of results The consortium found that "a region of chromosome 16p11.2 influences susceptibility to autism when it is either deleted or duplicated" in about 1 percent of all cases. This adds to the growing body of knowledge that autism has multiple genetic sources

But that won't stop the fanatics and their propagandists like David Kirby who claim that it is something else, even if it isn't thimerasol, just as long as it is something that corporations are pushing in a dark conspiracy with the government:

"All that said, thimerosal may well not be a factor in a single case of autism. But what if one day, we discovered it had caused, say, one percent of all cases? With estimates of autism as high as 1.5 million in the country, that would mean 15,000 Americans who were ravaged by thimerosal (not to mention everyone overseas).

But if thimerosal is vindicated, or shown to be a very minor player, then what about other vaccine ingredients? And what about the rather crowded vaccine schedule we now impose upon families of young children? And what about reports of unvaccinated children in Illinois, California and Oregon who appear to have significantly lower rates of autism? Shouldn't we throw some research dollars into studying them?

You can answer that, no, we shouldn't, because the vaccine-autism debate is over.

But I am willing to wager that it has only just begun."

I hear the black choppers whirling overhead.

http://content.nejm.org/cgi/content/full/NEJMoa075974  Read More & Comment...

How do you make a hormone?

01/10/2008 08:16 AM |

The FDA sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

The complete FDA announcement can be found here:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html

The FDA also responded today to a citizen petition from Wyeth, Madison, NJ, asking FDA to take regulatory action against compounding pharmacy operations that produce compounded "BHRT" drugs. Other stakeholders, including health care providers and consumer groups, have also raised concerns about "BHRT" drugs.  Read More & Comment...

Part D A Boon To Seniors

01/09/2008 10:53 AM |

Great minds think alike.. From today's Chicago Tribune by Bruce Japsen:

"After a rocky start, Medicare's drug benefit appears to be delivering a lower prescription tab for seniors, along with a whopping bill for the federal government, new research shows.

The Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

The savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage, according to a study released Tuesday on the Web site of the Annals of Internal Medicine ( http://www.annals.org ). A print edition will be published Feb. 5.

The study, considered by its authors to be the first in-depth examination of the impact of Part D, does not reveal shocking surprises in usage, considering the desire of seniors to have drug coverage. But its authors said the program was clearly working, reflecting the experiences of millions of Americans.

"We found that it had a modest but significant effect on both savings and drug use," said Dr. G. Caleb Alexander, assistant professor of medicine at University of Chicago Medical Center and one of the study's authors. "Despite extensive debate, it was not clear to what extent Part D would save people money or allow them to obtain drugs they might not otherwise be able to afford."

That debate is over. Now the question is, to what extent will we use incentives and new technology to match people to the right drug to promote the best outcome and quality of life. Or will we use one size fits all studies to drive people to the cheapest drug? Cost containment is just another word for profiteering if it doesn't add value to people's lives.

http://www.chicagotribune.com/news/chi-wed_medicare01.09jan09,0,4354066.story  Read More & Comment...

The Cost of Co-Pays

01/09/2008 08:10 AM |

Offering lower drug co-payments to people with diabetes, high blood pressure and other chronic diseases could increase use of preventive medicines, suggests a new study led by University of Michigan and Harvard University researchers.

Higher co-payments that took effect Jan. 1 are designed to help American employers cope with the rising costs of health insurance by making workers and retirees pay more out of their own pockets. But does it help health care outcomes for patients? No.

The study, funded by GlaxoSmithKline and Pfizer Inc., suggests that some drug co-payments should be reduced for some people with chronic diseases. Reducing the amount of co-payments by a few dollars would increase the use of preventive drugs by these patients. And properly treated, these chronic conditions can be managed effectively and cost -efficiently -- keeping patients out of the hospital or other more, er, horizontal places.

The researchers looked at a major private employer that made some medications free to employees and slashed co-pays for other drugs by 50 percent. This led to a significant increase in employees' use of preventive medicines.

The study authors also looked at another employer that kept co-payments at the same levels and found it didn't show the same increase in employee use of preventive medicines.

The findings were published in the January/February issue of Health Affairs.

"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."

Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.  Read More & Comment...

Are Online Healthcare Consumers Empowered Or Imperiled?

01/08/2008 12:25 PM |

You can be the judge and become a better consumer of online health care information after reading our report. Much of what passes for "information" is propaganda placed by trial attorneys, so-called public interest groups and alternative health sites to steer people away from taking certain drugs, making them feel they should sue if they did take them or replace them with things that are expensive because they are natural. In specific cases, which we provide, the information on the Web has contributed to a decline in public health and death.

The Web has become an organizing tool for those seeking to politicize science. Ironically, for all the concern about DTC the biggest and most dangerous source of disinformation is often provided by organizations that are the biggest critics of drug ads. When, for example, will Public Citizen and Consumers Reports do the responsible thing and take down all the inaccurate links to their sites about statins and liver damage? When will these organizations stop associating with the same trial attorneys that front load the Web with sites that scare people about the risks of drugs relative to their benefits?

Misinformation and disinformation regarding health issues could be a huge public health problem in the years ahead. We hope this study gives people an insight into how big and a common sense way of how to solve it: consider the source and consult your doctor before taking action.  Read More & Comment...

Scientific McCarthyism

01/08/2008 10:43 AM |

We are truly confounded by Senator Charles Grassley's "suggestion" that anyone inside the FDA with a beef about the safety of a drug simply vet it in front of an Advisory Committee.

Where could he have gotten such an idea? Perhaps from David Graham, who mixed and matched methodologies and half-baked studies to trash conclusions he disagreed with.

Here's a suggestion: Why not let other Senators from committees other than Finance weigh in with their own opinions, studies and comments during markups and in front of the cameras to trash and second guess the work of staff. Or better yet, let every buck private who disagrees with a procurement policy or a military tactic attack the decision after it's been debated and made. That's just a recipe for chaos.

The benighted effort to move decision making out of the realm of well-established processes of collegial review is an attempt to make all questions disputed and therefore political matters. To do so increases the amount of conflict around the issue of acceptable risk at a time when the FDA is developing and adopting tools that can define risk at the individual level and is creating systems to that can respond to risk quickly through personalized medicine.

It seems that Senator Grassley and Dr. Graham believe the risk of drugs flows from a conspiracy of silence between the FDA and industry. This is a naive and romantic view of safety that sells well but ultimately places the public health in grave danger by demoralizing scientists and discouraging innovation.

Leadership and courage will be required to stand up to his attempt at scientific McCarthyism.  Read More & Comment...

Mad Libs for Legislators

01/08/2008 08:16 AM |

Under the signature of Chairman Dingell and Mr. Stupak, the Energy and Commerce Committee is charging that Dr. Robert Jarvick isn’t qualified to speak on issues of cardiovascular disease since he’s not a "practicing physician with a valid license in any state."

As Peter Rost over at BrandweekNRX writes, “He's an M.D. but he never actually practiced medicine. Instead he changed the course of medicine, through his work."

Did Jonas Salk ever practice medicine -- or was he too busy saving mankind?

“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,” Mr. Dingell said in a press release.

Congress imitates the Colbert Report. Except their writers aren't on strike.

Rost writes. “This is grossly unfair. He clearly went through fire to get his medical degree and had more motivation than most. He then continued a career which led to one of the most notable breakthroughs in medicine. To get on his case and the fact that Pfizer is using him as a spokesperson is simply wrong.”

"Dr. Jarvik,” Pfizer responds, “ is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well."

Here’s a copy of the Dingell/Stupak letter.

Download file

It's Mad Libs for legislators. Insert NAME OF DRUG COMPANY. Insert NAME OF CEO. Insert ACCUSATION. Its fun for the whole family – and the media loves it!

Until it makes you look foolish.  Read More & Comment...

Part D spending is depressing ...

01/07/2008 11:30 PM |

... other, more expensive parts of the health care equation.

Prescription drug spending increased from 2005-2006 by 8.5 percent, the biggest jump in two years. But it corresponds with the sharpest drop in spending on nursing home, hospital and doctor services. This is what we who supported Part D had argued all along.

The article can be found in the latest edition of Health Affairs..

http://content.healthaffairs.org/content/vol27/issue1/?etoc
">http://content.healthaffairs.org/content/vol27/issue1/?etoc
  Read More & Comment...

Is that a brick in your pocket or are you just trying to call me to discuss the future of personalized medicine?

01/07/2008 02:49 PM |

Teresa Lee, vice president of payment and policy for AdvaMed, opines in The Journal of Life Sciences ...

“The advent of personalized medicine will not only mean better outcomes for patients, but for the health care system as a whole, as diseases will be detected earlier when they are less expensive to treat and when there is a greater chance for complete recovery. Eliminating the expense associated with latter stages of disease will save the healthcare system untold billions and allow more resources to be devoted to areas such as preventive services, to help combat disease before they even start.

Unfortunately, the promise of molecular diagnostics and personalized medicine might not be realized because of Medicare reimbursement policies that were devised for diagnostics technologies of 1984, back when a cell phone was the size of a brick and cost $4,000.”

Here’s a link to the entire article:

http://www.tjols.com/article-487.html

Lee’s conclusion?

"In order to address these issues and encourage innovation that will enable personalized medicine to fulfill its promise, it is important for Congress to pass the Medicare Advanced Laboratory Diagnostics Act, which will reform many of the outdated Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests.

Momentum is growing to enact this needed reform to modernize Medicare’s outdated reimbursement policies that will finally let the full potential of innovative molecular diagnostics and personalized medicine thrive. “

For more information on this issue, please see our earlier blog, "Chuck and Cover" at

http://drugwonks.com/2007/12/chuck_and_cover.html  Read More & Comment...

The Skittles Defense

01/07/2008 02:01 PM |

From the WSJ Health Blog ...

Claiming he popped Merck’s former painkiller “like it was Skittles” (sic), the pitcher expressed his concerns about the potential impact of the drug on his health. “Now these people who are supposedly regulating it tell me it’s bad for my heart. I don’t know what the future holds because of the medicine I’ve eaten, but I trusted that it was not harmful,” Clemens told Mike Wallace.

I may be wrong here, but I do not believe the FDA-approved label for Vioxx included any mention of either stupidity or hanging fastballs.  Read More & Comment...