If I were a Carpenter

03/28/2008 07:07 AM |

If I were a Carpenter or a Zucker or an Avorn, -- the three amigos who penned “Drug-Review Deadlines and Safety Problems” (NEJM, 2008; 358: 1354-61) – I’d be greasing up the old spin machine.

Consider the following from BioCentury Extra:

FDA refutes PDUFA safety study

FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.

The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.

Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.

And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.

Well, as they say in Harvard Yard, "veritas."

We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.

Yeah, right.  Read More & Comment...

REMS brûlée

03/27/2008 02:49 PM |

FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs
and Biologics

New FDAAA requirements being implemented

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.

“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”

In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.

The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.

The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf

One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.  Read More & Comment...

The Organizational Man(tra)

03/27/2008 07:15 AM |

Health policy analysts, physicians, pharmaceutical company executives, business leaders and government officials recently met in Washington at the CMPI-Duke University Patient-Centric Leadership Forum to discuss developments in this exciting field.

Previously we have shared some of the comments made by noted cardiologist Dr. Michael Weber (“Weber Grills”):

http://drugwonks.com/2008/02/weber_grills.html

and Dr. Ralph Snyderman, Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine (“The Greening of the American Health Care System”):

http://drugwonks.com/2008/03/the_greening_of_the_american_health_care_system.html

Today we are, as always, honored to share some of the comments offered by the hardest working man in American health care, Dr. Mark McClellan.

“We’ve got a healthcare delivery system that is organized the wrong way. It provides the wrong services with the wrong emphasis to get to personalized, predictive, preventative care. You can trace this back to the fact that reimbursement is wrong. We have payment incentives that encourage more intensity, especially after a health problem has developed and don’t have any real accountability for getting better results for patients’ health at the lowest overall cost. We have systems of choice in our healthcare system that don’t really give people a choice, where the policies, the coverage that you can get, is influenced by many factors beyond an individual’s preference.

There is a lot of potential for more targeted therapies, more prevention-oriented treatment strategies, more individualized predictive medicine. This is why I’m fundamentally optimistic about the future of our healthcare policies. As there is so much potential on the side of personalized, predictive patient-centric care, the discoveries are going to happen.

The question is simply how fast, and how quickly are we going to get to really irresistible pressure for the kinds of reforms that will close the gap between what we could do with the right reimbursement rules and the right ability for patients to choose their care?"

Yes, that is the question.

Full conference remarks will be available shortly. Watch this space for more details.  Read More & Comment...

Janet vs. Jerry

03/26/2008 12:53 PM |

Jerry Avorn ran a statistical analysis in the NEJM showing that there were more black box warnings and discontinuations after PDUFA than before.

If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.

Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.

On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....

The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...

http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1

http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj  Read More & Comment...

The Durbin's in the Detailing

03/26/2008 09:14 AM |

Senators Dick Durbin and Herb Kohl are proposing a federal grant program to allowing the hiring of physicians pharmacists and nurses who would to come up with "objective" promotional material (there's an oxymoron) about prescription drugs. These tax-payer paid reps would also go to doctor's offices to counter the promotion and use of higher-priced brand drugs that -- as the Senators claim -- are no more effective than generic versions.

If the goal is to increase generic prescribing shouldn't the generic industry be paying for these reps and the information? And if health care costs are the problem, why not send government paid reps to discourage use diagnostics, surgery and other services that are growing more rapidly than drug spending?

Oh wait, that's called rationing.

http://www.fiercehealthcare.com/story/senators-plan-bill-countering-pharma-detailing-tactics/2008-03-14  Read More & Comment...

Claire and Present Danger

03/26/2008 07:25 AM |

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

Um, no.

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

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

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

Ouch.  Read More & Comment...

Cost-Savings über Alles

03/25/2008 07:28 AM |

In CMPI’s new paper, “The Hazards of Harassing Doctors:Regulation and Reaction in Trans-Atlantic Healthcare," Dr. Alphonse Crespo, a Swiss physician, points out that focusing on cost-savings rather than patient care has unintended – but highly predictable consequences:

“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package” voted by the German parliament, introduces penalties for prescription of “expensive” drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.”

Dr. Crespo’s complete essay and the complete paper can be found under the “Reports” heading at http://www.cmpi.org.  Read More & Comment...

Failing to Connect the Dots on Drug Safety

03/24/2008 11:38 AM |

How can the WSJ run a piece on using genetics to redirect failed medicines to smaller groups of patients that are high responders and then engage in an orgy of second guessing about Vytorin? The Vytorin case is a clear example of seeking ways to personalize medicine and stratifying statin therapy according to particular pathways...but the thirst for headlines trumps science-based reporting.

http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right


DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."

But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.

Some expert. Some reporting.

http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php


http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link  Read More & Comment...

Failed Drugs or Failed Pathways?

03/24/2008 08:38 AM |

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

Here how the story begins:

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

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

And here’s the rest of the story:

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

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

Sound familiar? Correct – the Critical Path.  Read More & Comment...

Follow-on, Oh Canada

03/24/2008 07:05 AM |

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

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

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

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

Counter-Detailing the Gray Lady

03/21/2008 07:08 AM |

Two interesting reader comments on the issue of government-sponsored counter-detailing as discussed in yesterday's blog entry "Close(d) Encounters."

Names have been withheld to protect the intelligent:

Dear DrugWonks:

What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.

Dear DrugWonks:

I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?

PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share

And if pharma detailers drive up the cost of Rx, won’t their detailers do the same?  Read More & Comment...

NIH HIV Trials: Essential Inaction

03/21/2008 06:06 AM |

For those in Soros/Essential Action camp who fervently believe the way to develop drugs for global health is to have the government coordinate and run trials with IP seized from private companies, the latest HIV vaccine failures underscore the ideologically riven fecklessness of their position.

The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.

The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action  Read More & Comment...

Close(d) Encounters

03/20/2008 03:14 PM |

Did you see the house editorial in today’s New York Times, “Countering the Drug Salesmen”?

Here’s the link:

http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin

The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective” educational materials designed to provide physicians with “unbiased” guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing” force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.”

The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.”

Perhaps, but at what cost to patient care? And what about the fact that “unbiased” and “objective” are in the eyes of the beholder?

Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.

But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer” in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.”

Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads” will deliver the findings their “funders” wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.

That’s what “government” care really delivers.  Read More & Comment...

Sunshine Supermen

03/20/2008 07:16 AM |

Check out H.R. 5605, the “Physicians Payments Sunshine Act of 2008. The sponsor is Peter DeFazio (D-OR) and one of the co-sponsors is Pete Stark (D-CA). Here's a link to the proposed legislation:

Download file

(Another of the co-sponsors is Representative Dennis Kucinich – glad he’s getting back to work after the grueling primary season.)

The bill calls for the reporting of absolutely everything (and they thought of everything) over $25.00 considered “a transfer of value” to a physician.

(What’s the AWP for a large pizza and a liter of Diet Coke these days?)

The penalties are between $10,000 - $100,000 and multiple offenders can say adios to their corporate deductions for advertising related expenses.

According to Mr. Stark, “The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients’ best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."

Kickbacks? That’s a pretty strong accusation. Mr. Stark should apologize to America’s physicians and to the pharmaceutical industry he slanders so easily. And as far as America’s Medicare beneficiaries, Mr. Stark might also want to mention that the Medicare Drug Benefit (Part D) doesn’t "pay" doctors.

Mr. DeFazio issued some equally thoughtful and measured comments:

"If the billions of dollars drug companies spend taking doctors on trips to the Caribbean and to expensive dinners at the country’s finest restaurants are above-board, then the pharmaceutical industry should support our legislation. This bill will keep the pharmaceutical industry honest."

Speaking of “honesty,” Mr. DeFazio should own up to the fact that the aforementioned boondoggle trips and are against the rules.

But this has nothing to do with honesty and everything to do with posturing – and hidden agendas. (One of the groups supporting this legislation is Consumers Union – yes, the same organization that receives millions of dollars from foundations supported by the generic drug industry.)

The concept that big bad Pharma is to blame for everything, and that a $25.15 pizza party is at the heart of the destruction of medical ethics, isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue.

H. R. 5605 is just another example of superbity from our legislative Sultans of Sanctimony.  Read More & Comment...

The Hazards of Harassing Doctors

03/19/2008 08:10 AM |

The Center for Medicine in the Public Interest will shortly publish a series of essays on the consequences of physican disempowerment in both the US and the EU. The title of this collection is "The Hazards of Harassing Doctors," and features contributions by Dr. Alphonse Crespo (a Swiss physician) and Dr. Marc Siegel (an American).

The thoughtful introduction is penned by Dr. Fred Goodwin, CMPI board member and Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society. Dr. Goodwin is the former Director of the National Institute of Mental Health

Here is a taste of Dr. Goodwin's take on the situation.

William Osler, generally regarded as the father of modern medicine wrote "If you listen carefully to the patient they will tell you the diagnosis." Arriving at a diagnosis and appropriate treatment plan has always represented collaboration between individual patients and their personal physician.

But today physicians are increasingly seeing the decisions that they and their individual patient reach about a specific treatment plan second guessed by distant “third parties” (working for government or insurance bureaucracies) who, of course do not –indeed cannot- know the physician or the unique individual circumstances of a particular patient. Lacking any knowledge of the patient or the doctor, these bureaucrats must fall back on general “guidelines” as the basis for approval or rejection of a particular treatment. Having served on guideline development bodies I can tell you that, at best, they represent the kind of “lowest common denominator” conclusions necessary to get the many different opinions represented on a committee to coalesce into a consensus. At worst guidelines represent a deliberate effort to drive down the cost of treatment by emphasizing “one size fits all” treatment approaches. While the physician-patient relationship theoretically remains the fulcrum of good medical practice and medical progress, in reality it is rapidly being replaced – on both sides of the Atlantic – by guidelines.

This movement towards guideline-driven medicine to which access to healthcare and physician reimbursement is increasingly linked, is based on the assumption that variations in medical practice are not only wasteful, but also potentially dangerous. Eliminating variations in clinical practice, we are told, will increase quality and save billions that could be poured into covering more uninsured or increasing coverage. The key to standardizing treatments – and outcomes – therefore are guidelines based on a combination of retrospective analysis of randomized clinical trials and the results of large prospective studies that compare the cost and effectiveness of established treatments or drugs in certain disease areas.

I bring a special perspective to this subject because of my professional background. On the one hand I have been a practicing physician for nearly 40 years and during almost all of those 40 years I was medical researcher and policy maker at the National Institute of Mental Health (NIMH). Incidentally my long experience in a part time private practice came about as a consequence of government salaries at the time not being competitive with academia so that a private practice was allowed in order to retain talent.

I was director of NIMH during the health care reform efforts of the first Clinton administration and, as such, I participated in some high level meetings of groups that were part of the effort. It is now well known that the perspective of practicing physicians was not included in this health care reform effort and my involvement was as the government’s principal mental health official, not as a clinician. Indeed I doubt that any of the other participants in the meetings I attended even knew that outside of my government job I was a physician in the private practice of a medical specialty.

I present this history so that the reader can understand what I am about to say. The meetings I attended had a surreal “Alice in Wonderland” quality. Here were all of these intelligent, well educated, well intended professionals discussing meta-analyses of controlled clinical trials, outcomes research, etc, etc, and yet it seemed that that none of them really understood what clinical practice was all about – it’s about enormous individual differences even among patients with the same diagnosis, it’s about cross-over trials where the physician uses each individual patient as their own control, trying treatment B when treatment A isn’t working, etc, etc Today’s advocates for coercive guideline driven medicine (as opposed to guidelines which are advisory to the doctor and the patient) seem to be cut from the same cloth as the people I encountered on those committees in the early 90s, except that now the lure of saving money and increasing the profits of managed care companies provides a new level of passion and intensity to these efforts.

In Europe, doctors are limited by reimbursement patterns and practice guidelines designed to control costs. This trend is growing in the United States. Yet there is no evidence that limiting access based on reviews of clinical literature or large scales trials either improves outcomes or saves money. On the contrary, the outcomes evidence suggests that seeking to elimination variations in practice and prescribing is actually more costly and contributes to morbidity.

The practice guidelines themselves are not the problem, it is how they are applied and for what purpose. Voluntary guidelines provide the intelligent physician with a benchmark from which to mark a patient’s progress or the impact of prevention. I have been involved in the development of practice guidelines for the treatment of mental illness for nearly three decades. It is a given that by the time there are developed, the guidelines themselves are outdated as new clinical insights and biomedical discoveries inform and shape both diagnosis and prescribing. The rigid imposition of guidelines regarding what to prescribe and how to treat insure that doctors cannot tailor treatments to the patient or deliver the best care.

Finally, the emphasis on cost-containment undermines continuity of care. The recognition that someone with mental illness is twice as likely to suffer from heart disease, diabetes or hypertension reveals the interaction of disease pathways which themselves have been show to be highly individualized. The evidence-based medicine movement fails to incorporate such insights. Rather, by emphasizing studies that evaluate the treatment of one aspect of a particular disease in a vacuum, the EBM movement is contributing to fragmentation of care.

Clinical decision-making is becoming increasingly centralized and the domains of economists or physicians who crunch numbers but never practice medicine.

Watch this space for more excerpts from this new and timely publication.  Read More & Comment...

Spare Change?

03/18/2008 11:14 AM |

According to the RPM Report:

“FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.

What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations."

“I do not see her going back to CDER as business as usual,” von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.”

Here’s the complete story:

http://therpmreport.com/Free/41678225-dbfe-4f3a-972e-c223f74843d8.aspx?utm_source=RPMel

Some more aggressive retorts from the Commissioner:

Just because she has a long tenure in FDA management and is can be termed an “insider”, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.”

Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,” the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead” change at CDER.

Give 'em hell Andy -- it's about time.  Read More & Comment...

Falling into FDA's Web

03/18/2008 10:48 AM |

New website that is.

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

(We'll take FDA reform in any form.)  Read More & Comment...

Inhuman Healthcare Economics

03/18/2008 09:19 AM |

Here's Alan Greenspan on the economic models used by the Fed and the banking community that "justified" the deep exposure of some financial institutions in subprime mortgage instruments:

"The models used by the finance industry to determine risk and measure economic strength are too simple to fully account for human responses. We cannot hope to anticipate the specifics of future crises with any degree of confidence."

http://money.cnn.com/2008/03/17/news/economy/greenspan/index.htm?postversion=2008031707

Translation: the rational models of utility and discounting activities are outdated because they fail to capture rapid and wide variations in response to risk and uncertainty.

Similarly, comparative effectiveness research, complete with QALYs and the assumption that standardizing care will lead to lower costs and optimal health are essentially ersatz consumer welfare models based again on the "rational actor" view of economics. There is more variability in healthcare because valuations and value do not correspond to particular price but rather to individual perceptions of risk and uncertainty that are part and parcel of the effort to treat and prevent disease. The simple models developed to predict and shape human responses in the healthcare system will anticipate changes or outcomes with any accuracy. Nor have they.


We have come a long way from when the RAND experiment was conducted.  Read More & Comment...

Foul-Up on Posting About Follow-On Biologics

03/17/2008 01:15 PM |

A post on the wsj.com healthblog by Heather Won Tesoriero claims

"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.

Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "

Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!

I am sure the anti-capitalists who attack pharma and BIO will go wild...


http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj  Read More & Comment...

Uncertainty MD

03/17/2008 08:45 AM |

Those who think a comparative effectiveness institute will generate super savings by imposing standardization on clinical practice should read Benjamin Brewer's latest blog in the WSJ entitled "Uncertainty is My Co-Pilot"

http://online.wsj.com/article/SB120527311006228441.html?mod=djempersonal  Read More & Comment...