September 15, 2008

From Parklawn to Parking on the Lawn

by Peter Pitts

AP reports that Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that “officials hope will help it better protect the public health amid rapid technological and scientific change.”

40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.

That’s great news. But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.

It's a good problem to have.

CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.

1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.

Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.

But it’s not all rosy and it’s not as easy as reporting numbers.

The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.

All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.

Posted by peterpitts at 08:50 AM
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December 08, 2006

Pfizer’s Pfineset Hour

by Peter Pitts

When torcetrapib clinical trial results were presented to Pfizer chairman Jeff Kindler, he did not equivocate. Despite the financial implications, the trials were stopped immediately.

Tough choice? Yes. But, more importantly, principled choice.

The principle? Patient safety. And, as my father used to say, it’s not a principle unless it hurts to stand by it.

Bravo.

I must have missed the words of congratulations from the IOM, Senator Grassley, and Sidney Wolfe.

Posted by Peter Pitts at 12:44 PM
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September 27, 2006

About use and misuse in clinical science

by Michael Martell

When judging the benefits and harms of health care and predicting patient prognosis, clinicians, researchers, and others must consider many types of evidence. Medical research evidence is part of the required knowledge base, and practitioners of evidence-based medicine must attempt to integrate the best available clinical evidence from systematic research with health professionals' expertise and patients' rights to be informed about diagnostic and therapeutic options available to them.
It is hard to provide a correct recommendation based on the diversity and complexity of medical evidence available today and the difficult processes of assembling, evaluating and interpreting the data.
As stated in the end of this article, ‘no one should be allowed to make even tentative claims for medicines without decent proof.’ But on the other hand, no one can stop you from believing a drug might work – in this case to believe that injections of growth hormones make feel younger and more agile …

If you want to know more .. read full article below

The trouble with much medical research

The consequences of ageing, including wrinkles and - allegedly - diminishing libido, are no longer time-associated inevitabilities but life events of choice. At least according to Jeya Prakash, a Harley Street cosmetic surgeon, who says that after months of injecting growth hormone into himself and his wife, they have turned the clock back. He and his wife, he says, feel young again.
I feel bad for mentioning this because when a medical myth is repeated enough, it develops an unsinkable status hingeing on the fact that it "might" work. And since we're all into professing our frequent clinical uncertainties, who's to say that a little growth hormone might not just, literally, save
Let us rewind to the paper in the New England Journal of Medicine that stands accused as the source of the anti-ageing claims for growth hormones. Register and read the paper for free. There is, of course, no proof of a miraculous effect anywhere.
The paper is called "Effects of Human Growth Hormone in Men Over 60 Years Old" and was published in 1990. The measurements of lean body mass, adipose tissue mass, skin thickness and bone density were taken before and after six months of growth hormone injections. The men were leaner and thinner, their bones denser and their skin thicker - although not all of these results reached statistical significance.
The reason I'm mentioning this study is it makes some telling points about the way we use and misuse clinical science.
First off, note that the trial didn't actually measure anything relating to either perceived or actual quality of life, never mind wrinkles. Does it matter if a medication can increase your bone density by 2.3 per cent? Exactly what is the effect, in real-life terms, of increasing your skin thickness by 7.1 per cent?
We don't know. This initial study might have been quite interesting but it is here that big-time, powerful, placebo-controlled, blind studies should have been initiated. In other words, this is not a study to base a growth hormone industry on, a point that seems to have been lost post-publication.
The NEJM accompanied the 1990 paper with an editorial, saying much the same thing. It took until 2003 for another editorial to appear, this time with the results of a couple of other studies examining the effect of growth hormone, concluding once more that there was no proof behind anti-ageing claims.
This is the first troubling thing about so much medical research. The findings may be far from conclusive and it often doesn't measure what it would be very helpful to know.
Second, we are apt to get excitable about things that are not exciting. In fact, the whole MMR scare grew out of a paper that was similarly observational and involved a small number of patients who grew the measles virus from gut tissue.
This does not mean small studies shouldn't be published - au contraire. If a well-designed study is done the results should be available. But, as with the tomes of initial findings published every day, we need to follow research up with better, fairer and bigger studies to find more certain answers.
Preferably, we could do better again if we could set out to answer questions we really want to ask. Bottom line - is MMR safe? Fabulously large, long-term studies say with high amounts of certainty that yes, it is.
What of growth hormone? The question is not just about safety or even bone density and adipose tissue but about how it makes us feel. Does it make our wrinkles fade and our libidos sparkle? No evidence at all.
In fairness, in marketing itself as a "possible" relief for ageing, growth hormone is no worse than the shelves of other pseudo-medical substances that don't work and are allowed to make similar soft claims.
From most cough bottles to certain eye drops and the vast majority of multivitamins and detox supplements, all are allowed to say that they "may" have clinical effects.
Even homeopathic medicines, under recent changes from the Medicines and Healthcare Regulatory Authority, are allowed to state what they work for in the "homeopathic tradition". This is despite the lack of evidence for homeopathy in either biology or clinical trials. The MHRA say that homeopathic medicines will be licensed for "self-limiting conditions". (That's a clue - it means the condition was going to get better anyway.)
But what about remedies, say, for HIV or Aids that "might" work - like the alleged but nonsensical treatments for HIV such as vitamins, lemon, garlic or beetroot, which are heavily promoted by some political leaders in Africa when we know it is antiviral drugs that are capable of turning HIV from death sentence to chronic disease?
Doctors should be honest about what doesn't work - and that includes a lot of conventional medicines. But there is a difference between something that we know will work sometimes and where there is no evidence at all.
It's much harder - some say impossible - to prove a negative. But no one should be allowed to make even tentative claims for medicines without decent proof.

By Margaret McCartney (GP, Glasgow) / Published: September 9 2006 / Copyright: The Financial Times Limited 2006

Posted by michael_martell at 06:11 AM
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August 16, 2006

Death is Cheap

by Peter Pitts

Dead people are very cost efficient. They have no need for costly hospital procedures, pharmaceuticals, or home care. On the other side of the pharmacoeconomic spectrum are people who suffer non-fatal medical events like a heart attack or stroke-- and survive due to every kind of help our health care system can provide. Such interventions are often both extensive and extended. But we are compassionate and civilized and value life. Individually and collectively we choose and support expensive care over expedient demise. That’s why it's so urgent that we recognize the exigent issues surrounding our nation’s ill-placed focus on acute care while chronic care issues remain precariously in the background -- in terms of both policy and press coverage.

The recent IDEAL study is only the most recent case-in-point. After a slamma JAMA editorial extolling the findings that Lipitor (80mg) provides incremental reductions in multiple endpoints including non-fatal heart attacks (a whopping 17% decrease in fatalities) and cardiovascular events in high-risk patients compared to simvastatin (20/40 mg) — the mainstream press played down the whole study as only marginally significant. Well, life is lived between such margins — and when it comes to CVD, those margins are pretty wide. In 2005, $393.5 billion was spent on CVD — nearly twice the amount spent on cancer care. Between 1970 and 1990 life expectancy in the US rose an astounding 6.2 years — due largely to new therapies for dealing with CVD.

Today we have the opportunity to further extend our ability not only to live but also to thrive at a high level of performance. And the impact on our health care system — not to mention our society will change the world … but only if we pay attention.

Posted by Peter Pitts at 10:32 AM
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