Group Hugs Not Included

10/04/2007 09:27 AM |

From the FDA web site ...

The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.

The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.  Read More & Comment...

Plan B(TC)

10/04/2007 07:12 AM |

The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."

The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.  Read More & Comment...

Anemic Response

10/03/2007 07:35 AM |

CMS is now lobbying Congress (although since technically they aren’t allowed to “lobby” they will “educate" our legislators) to support their decision at a time when it is supposed to "open" to reviewing additional comments and criticisms. Hmm.

According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.

By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.

Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)

The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.

An outrageous end run around patients and clinicians? You be the judge.  Read More & Comment...

Sidney Taurel Goes “Open Kimono” on Pharmacovigilance

10/03/2007 07:01 AM |

During his keynote address at Cleveland Clinic's 2007 Medical Innovations Summit, Lilly CEO Sidney Taurel challenged the health-care industry, medical community and U.S. government to work more closely to bring about a "true information revolution in health care."

"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly," said Taurel.

"The use of prescription medicines always will be a matter of balancing benefits and risks. Frankly, that's the first and most basic insight that needs to be understood by health-care consumers, not to mention the news media and politicians.”

"Not to mention," indeed.

"Fortunately, systems are now within our grasp to much more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."

His call for an information overhaul comes as the national health-care system is getting increased scrutiny by patients, regulators and politicians. Nearly all of the announced 2008 presidential candidates are calling for better medical record-keeping and wider sharing of information to cut costs and improve care.

Not that anyone really understands what any of those plans are or what they say, or how they will be paid for. But that's another issue altogether.

And credit where credit is due, three years ago, Lilly became the first to disclose the results of all its clinical trials on the Internet.

Taurel singled out some groups that are swiftly moving to share health information, including the Indiana Health Information Exchange, a network used by 27 hospitals and 5,200 physicians to share the results of laboratory tests. The exchange allows physicians to see immediately whether their patients have had tests done elsewhere, and if so, what the results were, to avoid duplication and provide better care.

Lilly also is working with competitors Pfizer and Johnson & Johnson on a project to understand how to find telling information about drugs in large databases. The move comes as Lilly and other drug companies are focusing more and more on personalized medicine, trying to tailor medicines to smaller groups of patients with certain genetic predispositions or health conditions.

"Certainly, at Lilly, we spend hundreds of millions of dollars every year on clinical trials," Taurel's speech says. "But the key insight in our situation, and I think it applies quite broadly, is that unlike most other assets, health information actually becomes more valuable the more it is used, studied and applied. It does not depreciate."

Amen Brother Sidney.  Read More & Comment...

But Praising Her Never Gets Old

10/02/2007 07:13 AM |

She works hard with nary a word of praise, takes a lot of abuse and shoulders a heavy burden without complaint (mostly). So permit us to gush for a moment.

From the FDA web site ...

FDA's Dr. Janet Woodcock Honored by Alliance for Aging Research for Improving Healthy Aging

Named Indispensable Person of the Year for Health Research

The Alliance for Aging Research has chosen Janet Woodcock, M.D., FDA's deputy commissioner and chief medical officer, as the Indispensable Person of the Year for Health Research, for effective, innovative and ethical leadership.

Dr. Woodcock leads FDA's Critical Path Initiative, which is designed to improve the scientific bases for developing, evaluating, and manufacturing FDA-regulated products. In addition, she serves as the point person for a team of FDA scientists and policymakers who have been working on strategies to improve drug safety monitoring and the development pathway for treatments of disorders such as Alzheimer's disease that are associated with aging.

The Alliance presented the awards at its 14th Annual Bipartisan Congressional Awards Dinner earlier this month in Washington, DC.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award and other scientific awards, as well as six Special Citations from FDA Commissioners.

The Alliance is a nonprofit organization that promotes scientific and medical research for healthier aging.  Read More & Comment...

The Sym-Phoney of Health Care

10/01/2007 07:19 AM |

The word “fora” is the plural of "forum." The dictionary definition of forum is: the public square or marketplace of an ancient Roman city that was the assembly place for judicial activity and public business.

FORA.tv delivers discourse, discussions and debates on the world's most interesting political, social and cultural issues, and enables viewers to join the conversation. It provides deep, unfiltered content, tools for self-expression and a place for the interactive community to gather online.

Last week, at the 2007 Georgia Health Care Symposium, I shared the podium with, among others, former HHS Secretary, Dr. Louis Sullivan and Georgia Lt. Governor Casey Cagle.

Dr.Sullivan spoke eloquently on the need for a "symphony” of health care. I spoke, bluntly, about a “sym-phoney” of health care as defined by the three biggest lies in American health care:

* That cost is more important than care (and government know better than physicians what’s best for patients)

* That we use too many medicines (and it’s acceptable to let politics trump public health)

* That we have too many medicines (the myth of me-tooism)

My main point was (and is) that focusing on Practice Variation over Patient Variation neuters physicians and makes them nothing more than Medo-Crats.

The event was hosted by the Georgia Public Policy Foundation and captured on video by FORA.tv. The complete seminar can be found by clicking on this link:

http://cmpi.org/archives/2007/09/2007_georgia_health_care_sympo.php

It’s “must think” TV.  Read More & Comment...

FierceHealthCare First Again

09/28/2007 02:42 PM |

Agree or disagree, the FierceHealthcare/pharma/biotech dailies and their editors do the some of the best reporting and analysis anywhere. I love their editorials and commentary -- especially when I don't agree or am introduced to a new trend -- because they force a careful rethinking and readjusting based on facts, events and insights on health care and science. I learn a lot.

Case in point, Anne Zeiger's commentary on Wal-Mart's movement into health care. Zieger called this trend months ahead of everyone and her coverage is the most comprehensive insightful of anyone writing about this stuff.

"About a year ago I suggested, half tongue-in-cheek, that Wal-Mart might want to go into the business of providing healthcare services. The idea remains intriguing to me, particularly as Wal-Mart ramps up its retail clinics and cheap meds initiative.

As you probably know (if you haven't been under a rock for a year or two), Wal-Mart has rolled out a program under which it offers hundreds of commonly-used generic drugs for a flat $4 per prescription. The program has sparked copycat programs from rival retailers, generated a lot of talk and probably saved some patients some bucks. This week, it's extending the program to cover new types of drugs (such as an ADHD med), and what's more, has established a $9 tier which will allow it to broaden its offerings.

To me, this has implications well beyond the retail pharmacy sector. Not only will such moves continue to push business into the Wal-Mart pharmacies, they could indirectly support the retail clinic businesses emerging in its stores over the next few years. With price-conscious consumers already hitting the stores for retail healthcare, getting cheap medication makes a lot of sense.

What I'm getting at, here, is that offering cheap meds is likely to be followed by other strategies that cement Wal-Mart's position as an outpatient healthcare destination, such as clinical testing. Future enhancements could even include non-retail activities--probably, in partnership with local hospitals--such as community healthcare education programs or blood pressure screenings.

I admit I could be reading this all wrong, and that all Wal-Mart cares about is to generate more transactions for its core retail businesses. But when you consider that it's planning to launch 2,000 retail clinics in coming years, maybe the idea of Wal-Mart as provider isn't such a wacky notion. Sure, Wal-Mart has no experience offering healthcare services today, but somehow, I doubt that will stop 'em."

(Thanks Anne. And think transfusions too.)

http://www.fiercehealthcare.com  Read More & Comment...

No-Part Harmony

09/28/2007 07:27 AM |

The Patent Reform Act of 2007 (S. 1145) seeks to “harmonize” the American patent system with those of other nations. But, as Kevin Kearns of the U.S. Business and Industry Council has written, “do we really need to be "harmonized" with a calcified European system or the impossibly unfair Japanese system, not to mention the Chinese system, where intellectual property theft is a way of life?”

Bottom line is that the pending legislation would make it harder for patent holders to enforce their rights or win just compensation from those who infringe their rights. It would be harder to prove "willful" infringement, which entails punitive damages. The bill also includes a mandatory apportionment test that would lessen the value assigned to patents in most products.

Not only would the bill reduce the value of patents, but it would facilitate patent theft.

Under our current system, inventors can "opt-out" of having their application published by filing "only" in the United States and not in another country where it can be ripped off. The current bill would eliminate the opt-out provision.

Think “health care innovation.” Then think “India.”

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without robust intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits.

Does our patent system need reform? That’s a question for patent experts. Should we facilitate a patent system that disincentivizes pharmaceutical innovation? That’s a no-brainer.  Read More & Comment...

FDA Reform Act: Personalized Medicine vs The Plaintiffs Priesthood

09/27/2007 03:57 PM |

President Bush signed the FDA reform bill into law today. Now we'll see who gains control of the future of drug regulation: those who support personalized medicine and develop tools to make medicines safer and more effective by tailoring treatments to those best suited for them. Or the plaintiffs priesthood, the Grahams, the Avorns, the Nissens, the Furbergs who will cherry pick clinical trial data on the trial attorney/Soros/Public Citizen/ dime. The choice is between those who want to really reduce risk through better science and those who want to distort data to make us more afraid.  Read More & Comment...

Been There Done That (Critical Path)

09/27/2007 03:28 PM |

Our friends at the C-Path Institute have blazed that trail of personalized drug safety. Go to the C-Path website..it is full of initiatives and partnerships with the FDA. Ditto the folks at BG Medicine who have a CRADA with the FDA on a liver tox biomarker. Then there is the work of Dr. Ruano (that I have benefitted from directly -- put that in there because I know my critics just hate when I use personal examples ) with regard to side effects from statins at Genomas.

As Ray Woosley of C-Path asks about Personalized Medicine. When? Why Not Now?

http://www.cpath-institute.org
http://www.bgmedicine.com
http://www.genomas.net  Read More & Comment...

What Janet wants Janet gets

09/27/2007 09:39 AM |

From today's edition of the Wall Street Journal ...

Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN


WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.

The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.

The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.

The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.

"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.

The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.

Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.

The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.

Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.

Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.

Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs  Read More & Comment...

Comparative Effectiveness Conflicts

09/27/2007 08:53 AM |

I forgot to mention (because it's beaten into the mainstream mindset that only free market thinkers can be "conflicted")) that the comparative effectiveness crowd has some conflicts of their own, starting with the fact that they are funded by insurance companies. But I guess taking money from organizations that switch people from one molocule to another without telling patients is okay for bloggers like Health Care Renewal. The science linking statin response to genetic mutation is pretty compelling -- but maybe HCR wants to challenge the science in this area too?

Then there is the trial attorney/Soros/Avorn connection that is never disclosed. Drugwonks posted on that previously.

http://drugwonks.com/2007/02/iom_safety_committee_conflicted_and_confused.html  Read More & Comment...

Bad Medicine

09/27/2007 07:12 AM |

“If you want to save money and save lives, the "switching" we need in the United States is a one from a focus on acute care to one on chronic care.”

So begins a new op-ed in The Journal of Life Sciences.

The complete article can be found at:

http://www.tjols.com/article-289.html

To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.

The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.  Read More & Comment...

Health Care Renewal Defends Avorn, Defames Me

09/26/2007 11:14 PM |

Here's a weak effort to discredit my argument through misdirection and personal attacks. Only my kids can do that with any success.


http://hcrenewal.blogspot.com/2007/09/over-top-denunciation-of-comparative.html

I have posted my response below in case HCR doesn't see fit to publish it.

If you are going to attack me you had better have your facts right. Not even close.

1. You treat congestive heart failure with anti-hypertension drugs. Ask any doctor.

2. At the risk of being deliberately misconstrued again, I will refer you to the A-HeFT study and it's design which included BiDIl with OTHER anti-hypertensives to prolong survival from congestive heart failure.

3. As for the ALLHAT study, nice of you to ignore step 1. Let me quote Dr. Michael Weber who was an investigator in ALLHAT on the design of the study and it's impact on blacks..."it was poorly designed, the interpretations were disingenuous, it violated appropriate scientific reporting, and most frightening, it did something that was so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges: And one thing that did show up in favor of diuretics, the fact that they cause fewer strokes than one of the other drug classes, was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. "

Like I said Avorn attacked BiDil for being a lousy study but peddles his academic detailing plan and uses ALLHAT as a dispensing model.

You can try to sling mud about the fact that CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people -- but get your freakin facts right. If you don't know that hypertension drugs are used to treat heart failure don't talk about them. And I know a lot more about the ALLHAT situation then you ever will. What's nonsense is you trying apologize for a movement that places the cost of drugs over the quality of human life. As for the rest of the post, I am still waiting to see evidence that people are less interesting in hating drug companies than in helping people live. Most of the post are biased in that they believe drugs are part of the apparatus by which corporate capitalism maintains inequalities that harm society and the health care system. Keep drugs off the market and strike a blow for economic justice and health equity. If people die in the process so what? The end justifies the means. That is what drives the comparative effectiveness movement.  Read More & Comment...

Personalized Cancer Cures In Development...What Will CMS Knuckleheads Say

09/25/2007 10:30 AM |

Let's restrict access out of cost considerations and use safety as the excuse!!!

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/19/ncancer219.xml  Read More & Comment...

Sail on, sCHIP of State

09/25/2007 09:22 AM |

PRINCIPLES FOR REAUTHORIZATION OF sCHIP

From the Health Policy Consensus Group

* The primary focus of the State Children’s Health Insurance Program should be to cover children in families with incomes at or below 200 percent of poverty. States that wish to expand sCHIP to cover children and adults in higher-income families are free to do so with their own state funds.

For those above 200 percent of poverty, the appropriate federal mechanism for support is through a combination of tax reform and direct financial subsidies to help families purchase the private health insurance of their choice.

* The program’s subsidies should be re-structured to encourage the purchase of private health insurance. sCHIP subsidies could be used to allow parents to purchase the health coverage that they believe is best for their children, including adding them to policies that may be offered at their workplaces. Research shows that children and their parents benefit if the whole family is covered.

* The federal-state matching ratio for sCHIP funding should be changed to eliminate the distortions that exist in today’s system. States receive a higher federal matching rate for covering sCHIP recipients (which today include many adults) than they receive for covering children eligible for Medicaid, even though these Medicaid children are in families with lower incomes. Congress should focus on fixing the perverse incentives that reward states at a higher level for enrolling higher-income sCHIP children over poorer Medicaid children. The current funding formulas also mean more federal sCHIP dollars will go to wealthier states that can afford to expand the program than to poorer states that do not have sufficient state funds to expand their programs.

* sCHIP must not be turned into another entitlement program modeled after Medicaid, with unlimited federal funds matching state spending on benefits. That would add to the taxpayers’ already-overwhelming burden of tens of trillions of dollars in unfunded entitlement liabilities. It also would encourage states to use accounting tricks to inappropriately increase federal payments, as they have done for years in the Medicaid program. sCHIP must remain as a capped funding program to the states, and Congress must require states to live within their allocations.

Here is the complete Consensus Group statement:
Download file

Two-thirds of uninsured children are eligible for either sCHIP or Medicaid under current law, including many children under 200 percent of poverty who are not yet enrolled. Expanding sCHIP to children in higher-income families would mean shifting the focus away from these children who most need help and would grow the program into a middle-class entitlement that goes far beyond its current mission of helping near-poor children. Reauthorization of sCHIP should concentrate on reducing the number of near-poor children who are eligible for coverage.  Read More & Comment...

Let It (Not) Bleed

09/25/2007 07:22 AM |

Additional thoughts on warfarin, genetic testing and personalized medicine courtesy of Dr Caroline Wright of the Foundation for Genomics and Population Health (a charitable company registered in England and Wales) …

“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug (see previous news article), the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.

Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.

The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.

FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine”

Remember – PDUFA page 182. Working together we can accomplish great things for the public health.  Read More & Comment...

Fearmongering on SSRIs as a PR Tool

09/24/2007 12:43 PM |

Alison Bass (a former Boston Globe reporter with a long hate the industry bias) is the latest apologist for the increase in suicides as a result of the fearmongering over SSRIs. In an editorial called "Suicide Rates as a PR Tool" she attributes better mental health care and gun control (!) Really? So how are kids killing themselves now in the wake of better mental health care and stricter gun controls if SSRIs have nothing to do with it. The idiocy of zealot courtesy of another anti-medication fanatic, Univ of Maryland researcher Julie Zito.

Oh, Bass is the author of a forthcoming book entitled, "Side Effects: A Best-selling Drug on Trial." How about fearmongering and demeaning those who have struggled to combat suicide as a PR tool. Where does a suicide denier stack up next to a Holocaust denier.

http://www.boston.com/news/globe/editorial_opinion/



Others like Alex (I stole the documents) Berenson dismiss the number of suicides as so small as to really merit concern. Funny, when Steve (I want to cause people's hands to tremble a little bit before they write that prescription," )Nissen and Curt Furberg were foaming at the mouth about 25 'unexplained' heart attacks among kids taking ADHD drugs over a ten year period that was enough to demand a black box an entire class of drugs and for the NY Times to run story after story validating as opposed to questioning the concerns.

http://www.nytimes.com/2006/02/10/health/policy/10drug.html

http://www.nytimes.com/2006/02/21/health/21psyc.html?fta=y

Keep it coming. Every time these whack jobs and their apologists take a run at the work of Robert Gibbons -- which has been verified by Greg Simon at Group of Health Puget Sound and J. John Mann and many others -- the most extreme and dangerous they appear.  Read More & Comment...

Page 182

09/24/2007 11:34 AM |

In PDUFA, that is. Page 182. That's where the language creating the Reagan/Udall Foundation begins. And if you want to talk about real FDA reform -- its really the most important part of the whole package.

But what's been written about it can be summed up in two words -- almost nothing.

All the more reason to watch this space.  Read More & Comment...

My Take On Hillarycare

09/24/2007 09:53 AM |

The new Hillarycare  Read More & Comment...