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September 27, 2006

A Deadly Chicken/Egg Situation

by Peter Pitts

Luckily, last year's action by British regulators to nix half of the U.S. supply of flu vaccine didn't have deadly consequences. It very well could have -- which begs the question: would the British have nixed the entire vaccine supply had those shots been earmarked for use in Great Britain?

The British action may have seemed rash, but the real culprit is a failed market for new vaccines. It’s a market where science has stagnated, leaving us overly reliant on a few large suppliers and dependent on production processes that are antiquated and needlessly expensive. And that’s not even bringing into the debate the very real tort issues.

It’s an actual chicken/egg situation. Today chicken eggs are at the heart of a protracted process of producing flu vaccine, a practice that has changed very little since the first flu shot was introduced in the 1940s.

It still takes as many as eight months to collect millions of these delicate incubators from special chicken farms, using them to grow the viruses for the next season's vaccine. That means our health care leadership needs to guess, a full year in advance, what the prominent strains of flu will be so they can decide what should go into the chicken eggs and how many lots it should purchase.

According to many experts, two techniques, reverse genetics and mammalian tissue culture, hold the promise to accelerate the vaccine-making process while raising its quality. With cell culture, a flu virus is made to infect a cell line able to replicate itself over and over in large fermenting vats filled with special growth nutrients. This production process bypasses the egg as a factory altogether. The advantage is it can be scaled up quickly to meet rising demand, and it does not rely on chickens, so it can be done in a short timeframe.

These are not pie-in-the-sky processes. Polio vaccine is made using mammalian cell culture, and reverse genetics was used last year to re-create a SARS virus. While reverse genetics is farther off, the ability to grow vaccines on cultures filled with animal cells is well understood.

However, regulators inside the Food and Drug Administration have viewed these techniques with trepidation. Among other things, there is the theoretical fear that genes could jump from the cell cultures into the vaccine. Instead of pointing out problems and saying why it can’t be done, regulators must work collegially with industry and academe to develop both the basic and clinical science that will provide the sound science necessary to certify this process.

Another hurdle to a more modernized pipeline is the capital required to get into the business. It costs about $300 million to build a chicken egg factory and it takes almost five years to get a facility built and inspected. And unlike the economics of drugs, with vaccines grown in chicken eggs, the variable costs – those that need to be paid every year on each vaccine that is produced – are high. So manufacturers need both high price and high volume to recoup their investments.

However, with governments around the world buying a big share of each year’s production run, high prices are hard to extract. So vaccine makers must make up in volume and through lower production costs what they cannot make up on price.

It is a classic chicken/egg situation – vaccines cannot be sold at a low price unless there is very high volume, but it’s not possible to assure high volume without lower prices to dangle before governments and other bulk purchasers.

The result is why we are where we are today. Without the ability to innovate by incorporating cheaper and better production methods, vaccine makers have cut costs by squeezing their antiquated manufacturing processes to the chicken bone.

This is no way to run a market for a medical product so vital to the public health. Right now, our entire supply of flu vaccine is dependent on a few companies and a few factories. New technology would allow production costs to fall, and with it barriers to entry for many small suppliers. Companies should not have to supply half the U.S. market just to reach the kind of scale that makes vaccine production profitable.

The solution is to facilitate sound science and high quality technology. This public health double play will lower production costs and offer the opportunity for more manufacturers to broaden the production base. As the government looks for ways to fix the vaccine market, here is an immediate opportunity -- actively promote vaccination to stimulate demand.

Let’s take all the negative media attention and turn it into a long overdue public health communications effort. The public is primed for action.

Posted by Peter Pitts at 02:31 PM
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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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September 26, 2006

Adverse Events Beyond Healthcare

by MaryEllen O'Donohue

While none of us want to think about another 9/11, the fact remains that we live in a turbulant world where preparedness is the name of the game. While healthcare news is important, how should we continually move forward with our planned media activities of the day, while at the same time preparing for "adverse events" outside of the world of healthcare?

Remember, it is possible that any type of reporter -- healthcare or not -- may be personally touched by world events -- such as those in Iraq. This can include family members in the military, those with family and friends in the Middle East, and those with colleagues who may be covering the war from abroad. When speaking with the media about healthcare news during this time, we need to be sensitive to a reporter's personal situation. Additionally, we should communicate only relevant news information and not attempt to capitalize on healthcare issues that may be related or topical regarding a nation's crisis (believe it or not, this has been done in our industry and is not an ethical approach to our business).

Finally, remember during a national crisis to think outside of our healthcare box. The space we fight so hard to get into for many of our clients will naturally become limited as papers and broadcasters will move/refocus our healthcare contacts or utilize the space for more urgent, topical coverage.

Posted by maryellen_o'donohue at 03:57 PM
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September 25, 2006

IOM-anations

by Peter Pitts

I predict the following verbiage from the just released IOM report on FDA reform will NOT appear in any mainstream media reporting:

“Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug safety regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is not so.”

Thank you, IOM, for that very honest, bold, timely, and necessary statement. Sorry Senator Grassley. Can we now assign David Graham to the dustbin of history?

The IOM report makes many comments and suggestions. Herewith a few of my own (ps: I have added the appropriate report notation for easy referral):

* Needless to say, the single most important recommendation (and the one that must happen if any of the other ones stand a chance of success) is the very last one — “substantially increased resources in both funds and personnel for the FDA.” (7.1)

* I am glad the that IOM has included in their recommendations my idea of a standing FDA advisory committee on communications. I suggested just such a committee at the November 4, 2005 FDA Part 15 hearing. (6.1)

* A comprehensive review of agency-wide risk communication plans? Absolutely. Lack of centralization has led to overlap, inconsistencies and gaps. Paul Seligman should lead such a program — and immediately. (6.2)

* Similarly, a systematic review of adverse event reporting systems. Yup. When it comes to AERS, we cannot and must not allow miscommunication to lead to health-related unintended consequences. (4.1)

* I certainly agree with the IOM that, when it comes to DTC advertising, the FDA must draw bright lines. But I do not see how a “first five years” moratorium on DTC advertising advances public safety, public health, or public knowledge. Same goes for the black triangle. All that does is triangulate on fear and give trial lawyers a wonderful new weapon in their continued quest for greed. (5.1, 5.3)

* A more timely and comprehensive posting of clinical trials on clinicaltrials.gov? Yes. But as to early stage results — that still needs more debate. (4.11)

* More robust and public discussion of post-market study results. Absolutely. (4.13)

* Adcomm members should be as free of professional conflicts as possible? Duh. But we mustn’t scare away the best and the brightest — as would happen under the proposed Enzi/Kennedy legislation. (4.10)

* Adcomm review of all new NMEs? Shouldn’t that be the decision of the professionals at the FDA? Not all NMEs are alike, so why treat them so? Bad idea. A knee-jerk, Grassley-like suggestion. (4.8)

* Include research capacity in the agency’ s mission statement. This would be a terrific idea if the agency had research capacity — which at present it does not. it should. Fund the Critical Path and then amend the mission statement. (4.7)

* Build a CDER informatics capacity? Totally. (4.6)

* Have the agency work with government partners (such as the VA and DoD), drug companies, public and private insurers, health care provider organizations, and consumer groups to plan, organize and fund confirmatory drug safety and efficacy studies of public health importance. A good idea in theory, but the wording is very vague and could easily lead to a fascist regime of so-called “evidence-based medicine.” Do we really want the editors of Consumers Report telling us which dugs are safe and effective? More debate and clarity needed here. (4.3)

* A 6-year term for the Commissioner of the FDA. Yes. Let the person chosen as Commissioner of the FDA serve as free of the political current as possible. (3.1)

The IOM report has good and bad. But a good next step is to carefully consider them all and expeditiously move forward by taking to heart the words of Goethe that appear on the frontpiece of the report:

“Knowing is not enough; we must apply. Willing is not enough; we must do.”

Posted by Peter Pitts at 09:32 AM
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September 22, 2006

The Times They are a Changin'...Albeit Slowly

by Stephanie Koze

As recently as 20 years ago, women were still under-represented in clinical trials. The inequity made it difficult to observe women’s responses to medicine and to understand how certain health conditions affected women.

We’ve traveled far, especially when it comes to grasping issues such as breast cancer and women and heart disease. But, our journey is not complete. Breast cancer research and heart disease research in women must continue. And, we still have many miles to travel to understand other diseases, such as lupus, multiple sclerosis (MS) and rheumatoid arthritis (RA), all of which affect women at disproportionately higher rates than men.

The National Institutes of Health’s division of Allergy and Infectious Diseases has made a concerted effort to study lupus, MS and RA. Fortunately, their trials include a significant number of women.

Let’s support these trials and continue to research gender-based differences in medicine.

Posted by stephanie_koze at 10:43 AM
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September 21, 2006

A Hard Truth

by Peter Pitts

One of the most difficult meetings I ever held at the FDA was with a group of parents (mostly moms) of teenagers who had committed suicide while taking SSRI antidepressants. In the wake of a very emotional advisory committee meeting, heavily covered by the media, these well-meaning and understandably devastated parents believed that these medicines were the cause of their horrible losses. I listened. Afterwards I wept. A parent of two children, I cannot even begin to understand their agony.

But as much as they needed to believe that the medications were at fault, the science was never clear. Anecdotal events, even terrible ones, are not science. Now a major new study, the first of its kind, finds that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.

And before you ask, no, the study was not funded by a pharmaceutical company. The funding came from the NIH and the Dana Foundation. (The full study appeared in the June issue of the journal PLos Medicine.)

For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.

Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.

Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.

Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.

With that in mind, moves to restrict the use of SSRI antidepressantscould have a harmful effect, the authors stated.

“I don’t think these claims that antidepressants increase suicide have a solid base,” said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.

“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.”

Whille this new science will provide little solice to the parents I met, it will help mental health professionals, their patients — and their patients’ loved ones — better understand the value of available therapies.

And that’s important. Very.

Posted by Peter Pitts at 07:51 AM
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September 20, 2006

Bringing a Knife to a Gunfight

by

Major national public opinion polls show healthcare to be among the top five issues on voters’ minds as the country heads into the election season. Just after Labor Day, Harris asked Americans what they saw as the “most important issues for the government to address.”

“The war” ranked first, at 22%
“The economy” was second, at 13%
“Healthcare” was a close third, at 12%

Political debates quickly reduce to good guys, heroes, and saviors fighting bad guys, villains, and sinners. In the healthcare debate, the pharmaceutical industry daily finds itself in the latter category with maddening consistency.

From a reputational standpoint, the industry has taken a lot of bullets. The way my colleagues and I see it, the industry is more often than not bringing a knife to these gunfights.

Big Pharma is far from perfect, but it can legitimately lay claim to scientific and medical advances that have in recent years alone…

…made ulcer surgery a relic of the past
…reduced hospitalization and surgery for heart disease
…delayed the need for nursing home care for many Alzheimer’s patients
…prevented strokes
…decreased the death rate for HIV and AIDS, and
…increased survival rates for people fighting cancer

No, the pharmaceutical industry shouldn’t expect a big wet kiss in the court of public opinion, but it deserves a lot better than the beating it’s taken, especially at the hands of trial lawyers. The amount of monetary damages in pharma-related cases is staggering. Estimates peg the American “tort tax” at $40 billion, an economic behemoth roughly twice the size of Coca-Cola and almost precisely the same amount, $39.4 billion, invested in 2005 by the pharmaceutical industry for the research and development of new, life-saving therapies. Litigation costs have also helped drive up the price of health insurance, which has risen 11-14% each year since 2001.

In MS&L’s view, the pharmaceutical industry must develop comprehensive, holistic strategies that harness the power of media relations and communications, legal strategy, and public opinion research (the weapons so successfully utilized by the trial bar and its allies) to protect itself against a coming barrage of reputation- and business-destroying attacks. What we continue to see is siloed, legally-focused responses to well-developed, comprehensive campaigns orchestrated by plaintiff attorneys.

My colleague Peter Pitts and I authored a white paper that expands on this problem and offers tangible and workable advice for pharmaceutical companies to level the reputational playing field. It’s called “America’s Legal System Is Dangerous To Its Health.”

It draws on our experience, observations and fervent hope that the industry will heed this important wake-up call.

I hope you’ll give the full paper a read – and post your thoughts here.

Posted by at 03:42 PM
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Tshabalala´s remedy: "Garlic, lemon and African potato"

by Michael Martell

Once, an African story-teller told me that real African stories are never written down but are given from generation to generation by oral tradition after sunset sitting around a campfire.

Tshabalala´s remedy story is definitely not a funny tale, it is really a mess. I can understand that scientists, physicians and patients are upset and demonstrate their concerns. But I am at a loss with an answer to the question "How to change her mind and story-telling". Maybe it will help, that journalists have written it down.

Read full article of Financial Times Europe below:

Mbeki's Aids policy 'disastrous'

A group of 81 international scientists working on HIV/Aids have written to Thabo Mbeki, South Africa's president, urging him to end his government's "disastrous, pseudo-scientific policies" on the disease.

In an "Expression of Concern by HIV Scientists", the group also called on Mr Mbeki to sack Manto Tshabalala-Msimang, his health minister, nicknamed "Doctor Beetroot" for her unorthodox views on treating Aids.

The scientists claimed that she had undermined their field by advocating "alternative" remedies to antiretroviral (ARV) drugs, the only medications currently available that alleviate the consequences of HIV infection.
"We are . . . deeply concerned by the proliferation of unproven remedies being marketed in South Africa, some of them with the implicit or even explicit support of the minister of health," said the letter, made public yesterday.

Signatories of the letter included Robert Gallo, credited with co-discovering HIV, and David Baltimore, a winner of the Nobel Peace Prize. The group also endorsed remarks by Mark Wainberg, chairman of the recent international Aids conference in Toronto, describing Mr Mbeki as a "denialist president".

Mr Mbeki has in the past questioned the link between HIV and Aids and the effectiveness of ARVs. Ms Tshabalala-Msimang has angered Aids activists by belittling ARVs and advocating garlic, lemon and the African potato as remedies for patients with suppressed immune systems.

The South African government exhibition at the Toronto conference featured samples of these foods, provoking derision and anger among Aids scientists and activists. "To have as a health minister a person who now has no international respect is an embarrassment to the South African government," the letter said.

South Africa has more than 5m HIV-positive people and one of the world's largest Aids treatment plans. But activists say that fewer than half of the people who need treatment receive it.

No immediate response was available from Mr Mbeki yesterday. He has in the past publicly supported his health minister, whom he reappointed to her post after his re-election to a second term in 2004.

Ms Tshabalala-Msimang is the wife of Mendi Msimang, the treasurer of the ruling African National Congress.

By John Reed in Johannesburg / Published: September 7 2006 / Copyright: The Financial Times Limited 2006

Posted by michael_martell at 12:21 PM
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September 19, 2006

The new business model...positioning for a sell

by Kelly McKenna

Biotech and biopharma companies are increasingly looking to sell. While, in the past, these early to mid-stage companies wanted to do it themselves - commercializing and marketing their product, going public, building their pipeline and maturing into a Genentech or Amgen. With Wall Street less inviting, they're now exploring more lucrative alternatives to IPOs. Reflecting this trend, there were more IPOs in European biotech last year than U.S. biotech. Granted this was also a factor of globalization of the field and a conservative U.S. investment market.

As PR professionals, we need to: 1) help our clients position themselves favorably to potential buyers, an audience now just as important as investors, and 2) prepare and protect ourselves from erosion through ongoing mergers and acquisitions. This is particularly an issue in California, where hundreds of biotech start-ups pop up every year.

Posted by kelly_mckenna at 11:37 AM
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Tip of the ... Iceberg?

by Peter Pitts

We all owe the FDA a “thank you” for their timely and robust approach to the current E. coli outbreak.

Special kudos to agency expert David Acheson for his (as usual) high quality media performance (both form and substance).

I am pleased that there has been no reference to the agency being in the pocket of “Big Spinach.”

At least not yet.

Posted by Peter Pitts at 07:11 AM
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September 18, 2006

Got pain? Me too.

by Peter Pitts

Here’s another swat at the myth of me-tooism — not all Cox-2 medicines are alike.

I know, duh, right? But it sounds so much better when you read about it in the Gray Lady. Here’s how Alex Berenson began his story on the topic:

“Vioxx, which is no longer on the market, may have posed heart risks that a similar drug, Celebrex, and other painkillers do not, according to two papers published yesterday by The Journal of the American Medical Association.”

There you have it. And if it’s in the New York Times it must be true, right? Well, yes — at least in this case. And it’s an important one.

Today’s lesson is that the public health value of multiple medicines within the same therapeutic class must not be arbitrarily waved away. Just as there are no “me-too” patients, so too are there no “me-too” drugs. An expanded pharmaceutical armamentarium offers both doctors and patients the opportunity to choose the right drug for each individual patient based on a plethora of mitigating factors — including the risk profile.

Personalized medicine. Get it?

One “class” that clearly doesn’t get it, the Retailers of Recreancy and Rapacity (trial lawyers and their allies), must not be permitted to tar an entire class when risks are found in a single product. There are varying risks and benefits among different products in a single class as well as among different classes of drugs used to treat the same disease.

That’s called progress.

Posted by Peter Pitts at 07:07 AM
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September 14, 2006

Qui tacet consentit

by Peter Pitts

The Washington Legal Foundation has filed a petition with the Food and Drug Administration challenging the agency’s right to send warning letters to drug companies whose advertising it finds misleading.

The WLF believes the letters — which carry no legal weight but are routinely obeyed — contravene the First Amendment by making it impossible for drug marketers to advertise information that is not reviewed by the FDA even though it may be truthful and accurate.

Rather than having the WLF file a petition that will not go anywhere, individual pharmaceutical companies should muster the pluck to energetically challenge DDMAC when they receive letters they feel are unfair.

Qui tacet consentit. Silence implies consent.

Posted by Peter Pitts at 07:50 AM
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September 13, 2006

Kid's and Health: It's A Bold New World

by Stephanie Koze

The recent approval of Merck’s HPV vaccine for young women ages 9 to 26 and the emerging trend of young athletes suffering from injuries linked typically to older, seasoned professionals are just two dramatic examples of a changing healthcare landscape for children.

Children, parents and the medical professionals who treat children are now being confronted with a new host of medical conditions to consider – opening uncharted territory for media, consumer and professional education.

From a communications perspective, how do we confront these issues and what do we say to our kids? Take a look at Christine Gorman’s Sept 10th TIME Magazine article, “To an Athlete, Aching Young” .

She raises some interesting points.

Posted by stephanie_koze at 06:07 PM
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A Blogger's Banquet

by Peter Pitts

Wither pharmaceutical blogging? Have a look at the attached article on the “New Frontier” of pharmaceutical communications and one of its feisty evangelists … me.

Here’s the link:

http://www.bizjournals.com/sanfrancisco/stories/2006/07/10/newscolumns.html

Posted by Peter Pitts at 12:47 AM
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September 11, 2006

Epigenetics: an area to watch

by Kelly McKenna

Following the mapping of the Human Genome and new insights regarding DNA, epigenetics has increasingly gained attention and funding – mainly because many scientists see it as the next step in translating information about the human genome into therapies.

Epigenetics refers to how modifications or “marks” to genes - other than changes in the DNA sequence itself - affect gene expression. Essentially, they’re an instructional code that overlays DNA. For industry, it will likely provide unique insights on the genetics of a disease that translate directly into therapies. Additionally, according to a May 10th Nature article, "epigenetic codes are much more subject to environmental influences than the DNA sequence", which “could explain how lifestyle and toxic chemicals affect susceptibility to diseases”.

While the role of epigenetics is still under investigation in a variety of diseases, positive data has been published regarding epigenetics in cancer therapies, specifically for liquid tumors. Evidence has shown that the epigenetic silencing of key genes – such as tumor suppressor genes – may be reversible, giving experts hope that epigenetic approaches to cancer therapy could not only treat cancer, but also help to prevent it. Instead of using molecules that kill tumor cells (and, often, healthy cells in the process), epigenetic therapies “reactivate” silenced genes to restore the natural mechanisms that control abnormal cell growth.

Several leading oncology organizations and research institutes are now focusing more heavily on the field. For example, within the next few weeks, charter members of the International Human Epigenome Project (IHEP), an international effort proposed by the American Association for Cancer Research (AACR), plan to publish results from their first meeting, held in July. Keep your eye out for these results as well as more attention to the field during the upcoming America Society of Hematology (ASH) meeting in December.

Posted by kelly_mckenna at 07:51 PM
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Tropical Storm Safety

by Peter Pitts

Owing to genuine concerns about pedigree and counterfeiting (courtesy of the FDA’s aggressive use of the Bully Pulpit), together with the successful rollout of the Part D drug benefit, the issue of foreign drug “re-importation” has lost much of its political allure and momentum. Most of the elected officials calling for the “legalization” of foreign drugs have since abandoned their incautious and dotty schemes. Aeternum vale!

But political bloviation abhors a vacuum. Taking the place of drugs are too expensive is the new clarion call of drugs are not safe. A sure-fire political winner. After all, who could be against “safety?” Safe = Good. Unsafe = Bad, right? Well, not exactly. As Dr. Mark Goldberger, director of FDA’s office of antimicrobial products commented, “It’s more complex than it seems at first glance.”

Safety has been hijacked. Safety is the new Re-Importation. But it’s the same old story.

And it sure plays in Peoria or, perhaps more appropriately, in Des Moines. Not surprisingly, the media loves it because; although the pressure point is different the “victim” (the patient) and “the villain” (the pharmaceutical industry) are the same. And, as everyone knows, it’s more than okay to kick the stuffing out of Big Pharma (or, if you prefer, “Big Pinata”). It’s a free hit. Sanctimonious quotes and macho strutting results in terrific headlines for the folks back home.

A little harmless politicking? Hardly. Just ask the people who no longer have access to the medicines they need (like Vioxx), or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result is a dearth of new medicines in the pipeline.

Is it safe? Ask the FDA. Is it politically safe? Ask a Senator. Is it remunerative? Ask an attorney.

What does “safe” mean, anyway? 100% safe? Certainly not. All drugs have risks as well as benefits. And more often than not the more serious the disease the more serious the risks associated with the treatment. Consider advanced non-small cell lung cancer. Then consider Iressa. Are such medicines risky? Indeed they are. Are the diseases they treat serious enough for patients to accept such risks? Decidedly. Consider Multiple Sclerosis. Then consider Tysabri.

But most importantly, consider the Precautionary Principle, the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines. Fatal like in death.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.

Posted by Peter Pitts at 07:58 AM
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Formula 1 race at WHO

by Michael Martell

Who will be responsible for the global fight against HIV/Aids, TB, Malaria and Avian Flu in the next five years? Out of 13 candidates, a hand full will be short-listed in second week of November in Geneva and one of those will become the new director-general of World Health Organisation WHO.

From October 6 you will have the opportunity to learn more about the candidates from all over the world. Visit who.org and do not hesitate to give your vote at healthspeak.net.

See full article of Financial Times Europe below:

Rivals line up to lead drive for better health

The race to lead the World Health Organisation for the next five years kicked off on Wednesday with publication of the list of 13 candidates standing for election as director-general.

Past and present WHO officials and top national politicians are among those who have put their names forward for a job that will prove central to shaping efforts to reduce premature deaths around the world.

The WHO, with a budget for 2006-07 of $3.3bn (€2.6bn, £1.8bn) and 8,500 staff, will play an important role in efforts to achieve the United Nations millennium development goals, which aim to cut child mortality, improve maternal health and reverse the growth in the world's leading infectious diseases.

The election, coupled with the selection of a new executive director for the UN-backed Global Fund to fight Aids, TB and malaria, comes at an important time for global health, after the pledge by the Group of Eight leaders to push for as close as possible to universal access to Aids treatment for those who need it by 2010.

It also coincides with a debate on the need for change in the operation of the WHO and more broadly across the entire UN system, and as the race advances to replace Kofi Annan as secretary-general.

Details of the candidates are to be circulated by October 5. The 34 countries on the WHO's executive board will meet on November 6-8 to short-list about half a dozen for presentations and interview.

In a process that has been criticised for its secrecy, they will vote by ballot until a simple majority emerges for one candidate, who is formally then proposed to a full meeting of the 192-country World Health Assembly on November 9. The process will be highly political, with candidates proposed by Burma and Syria, and five from Europe. China and France have both backed a candidate, breaking an informal understanding by some that members of the UN Security Council should not stand.

Some argue it is time for Africa to lead the WHO, particularly given the continent's enormous health challenges and following the departure of Mr Annan, a Ghanaian, as head of the UN. Two past director-generals have been from Asia, and nominees this time from China and Japan risk splitting votes in the region.

The elections were triggered by the unexpected death in office in May of Dr Lee Jong-wook from South Korea, who was credited with implementing important policies including efforts to scale up HIV treatment around the world.
However, he often avoided conflict, notably with the US over issues including intellectual property protection and with China over the status of Taiwan. He also sparked internal animosity with his style in restructuring the agency and decentralising staff from the Geneva headquarters, triggering a strike late last year.

Many critics argue that the WHO's structure, with much of the budget and many nominations determined by its regions, needs to be reformed but that the director-general would need widespread country support to bring about change.

Kamran Abbasi, the editor of the journal of the Royal Society of Medicine in London, said: "The central issue is how much happens at the centre. There is a need for decentralisation backed up by resources."

He also said there was a need to shift from the WHO's focus on communicable diseases to non-communicable ones such as diabetes, which are increasingly important in the developing as well as the developed world. "The WHO was set up to fight communicable disease but this should be a dynamic organisation, not entrenched in a 1940s view."

Prof Christopher Murray from Harvard University said the WHO had a clear advantage in setting standards but there was debate on the suitability of its staffing and resources to translate and implement such guidelines in individual countries.

He also called for a strengthening of the WHO's role in epidemic surveillance, and developing evidence-based policies to strengthen health systems. "There is a lot of rhetoric in this area but little progress. However, everyone involved in scale-up of programmes recognises that how systems are organised, how staff are trained and paid, how they are regulated and managed are absolutely critical."

By Andrew Jack in London, Frances Williams in Geneva and Tom Mitchell in Hong Kong
Copyright The Financial Times Limited 2006 / Published: September 7 2006 03:00

Posted by michael_martell at 06:35 AM
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People can shop around in the EU

by Michael Martell

In early September, EU health commissioner Markos Kyprianou said that he will fight to strengthen the rights of patients in Europe to travel across the 25 European countries for treatment and that national health systems should pay for it.

See full article of Financial Times Europe here:

EU healthcare ‘must brace for revolution’

Europe’s public healthcare systems must brace for radical change as barriers to patients crossing borders to seek treatment drop, the European Union’s top health official said on Monday.

Markos Kyprianou, EU health commissioner, told the Financial Times that he would act to implement the right of patients to travel for treatment across the 25-member bloc in the wake of recent court judgments.

While so-called health tourism is on the rise, many EU members have argued that medical services fall outside the scope of its single market.

But the European Court of Justice has found that they do not. In a ruling in May on the case of British woman Yvonne Watts, who went to France to avoid a year-long wait for a hip operation, the court said patients facing “undue delay” should be entitled to be treated in other countries and paid for by their national health systems.
Mr Kyprianou said: “The internal market applies to health services. People can shop around.”

Opening the market could provide lucrative opportunities for private providers to lure clients from across Europe.
The move would have big budget implications for countries such as the UK, which effectively rations healthcare by limiting capacity and having long waiting lists. EU health spending rose from an average 7 per cent of gross domestic product to 7.7 per cent between 2000 and 2003.

On Tuesday Mr Kyprianou will launch a debate, requested by member states, in the European Commission that will lead to proposals within months for how the market should function.

“We need to give people information. For example, if you want a hip replacement, where do you go, which country? There must be a better way to help the citizen make a choice,” he said. “On the other hand, can a receiving country turn down a patient?”

About 1 per cent of operations across the EU involve people from other countries. Defining “undue delay” will be one thorny issue. “I am not going to produce a list of time limits,” Mr Kyprianou said. There is also the question of liability if an operation goes wrong and who should pay for follow-up treatment when the patient returns home.
Patients could only travel for treatment that would be available in their own country and at the same price. They would have to meet extra costs themselves.

Jim Murray, director of European consumer lobby group BEUC, welcomed the debate. “Patients need much more clarification of their rights,” he said.

Although José Manuel Barroso, the liberal president of the European Commission, wants to go further. Many members insisted health be excluded from a recently-agreed EU directive to liberalise trade in services.

By Andrew Bounds and George Parker in Brussels
Copyright The Financial Times Limited 2006 / Published: September 4 2006 22:00

Posted by michael_martell at 06:20 AM
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September 08, 2006

Good Golly Ms. Holly!

by Peter Pitts

As usual, Holly cuts to the crux of the matter -- health care and politics don't mix. Not only that, but that unholy mixture actually serves to retard progress.

Consider a new WHO study that reports India, China and Russia will suffer losses of billions of dollars in national income over the next decade unless investments are made to prevent rising levels of chronic diseases. A March 2005 research synthesis from HHS’ Agency for Healthcare Research and Quality estimates that the United States could save nearly $2.5 billion a year by preventing hospitalizations due to severe diabetes complications. But the global debate shouldn’t be primarily about the money — it should (indeed must!) be about saving lives. And the debate needs to begin at home.

In 1979, 31,691 Americans had a foot amputated because of undiagnosed and untreated diabetes. Last year that number grew to over 80,000. And hundreds of thousands of heart attacks and strokes, caused by high blood pressure and high cholesterol, cost the American health care system billions of dollars. The cost in terms of human suffering cannot even begin to be measured.

The argument that health care is “too expensive” is too broad. The proper argument is that waiting for Americans to get seriously ill and then intervening is too expensive. Earlier diagnosis and earlier, continuing care is crucial to the future health of both Americans and of the American health care system.

We cannot afford, in terms of either dollars or lives, to continue playing the health care “blame game” — because disease is the enemy and the cost of disease is staggering. One part of the blame game is about health care prices — for hospitals, insurance, drugs, and doctors. Rather than looking for a villain, it’s time to start asking the hard questions and finding the right answers — and focusing on how to reduce the price of a diabetic amputation is the wrong approach. We need to do the things that can be done to prevent it in the first place, because that’s the best way to save money and improve lives. And we need to do this now, because we also want to be able to invest in and afford better treatments for other conditions — cancer, Parkinson’s, etc. that are so desperately needed and that hold so much promise.

The first step in this process is an honest, broad-based dialogue. In order to revitalize our health care system we must refocus the debate about health care. In order to save lives, reduce costs, enhance quality and deliver on the promise of robust health to all groups of Americans, all of the players in the health care debate — including government must work together as a team, as a unit, as a public health defense force armed and ready to advance the pubic health.

Posted by Peter Pitts at 07:26 AM
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September 07, 2006

Survey Says: Innovative Healthcare Solutions and Politics Don’t Mix

by Holly Heline Jarrell

Decade after decade, in poll after poll, the public beseeches Congress and the President to focus their attention on a broken healthcare system. In a recent Harris Interactive survey on behalf of The Commonwealth Fund, an overwhelming majority calls for “fundamental changes” to – or a “complete rebuild” of – the system. See link: http://www.cmwf.org/surveys/surveys_show.htm?doc_id=394593 (You’ll find like sentiments echoed in plenty of free-standing polls as well.) Whether innovation comes in the form of better coordinated care, computerized health records or new thinking on how to ensure the solvency of Medicare (majorities support all of these), Americans see healthcare policy change as “job one” for Congress (or “two” depending on the pollster). This is not new.

But there is new evidence that the public shouldn’t hold its collective breath waiting for out-of-the-box health policy thinking at the Congressional level. For its voter guide, AARP recently conducted a survey among Congressional candidates on issues including Medicare and insurance plans. Forget the tabulated results, the real story is found in the thoughtfulness of the respondents: To answer the survey, candidates in Georgia, Illinois, Iowa, South Carolina, and Texas simply copied – word for word in some cases – party-line sound bites originating from the National Republican Congressional Committee. (As a survey professional, I find this an appalling way to deal with an “open-ended” question – it defeats the purpose!)

Democrats blast the GOP candidates saying the “plagiarized” survey results suggest “more of the same.” See link: http://www.forbes.com/technology/ebusiness/feeds/ap/2006/08/31/ap2986766.html
The story really isn’t all that political, though. It could happen on either side of the fence. Rather, the lack of original thinking – or thinking at all – makes one simply question the possibility of creative healthcare solutions, open dialogue, and – dare we say, innovation – from the Hill.

Posted by holly_heline_jarrell at 04:09 PM
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September 06, 2006

Taking it personal(ized)

by Peter Pitts

What’s the trade-off between quality and speed? Can’t we have both? While this is a regular debate in the world of pharmaceutical development — it’s not so familiar in the realm of diagnostics. Until now — and it’s about time.

The issue at hand is FDA’s new draft guidance on a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.

Here’s a link to the FDA announcement:

http://www.fda.gov

I also suggest, as recommended reading, an article in today’s edition of the New York Times by the always thoughtful Andrew Pollack. (Sorry — I am not able to provide a hot link, but the title is “F.D.A. Seeks to Regulate New Types of Diagnostic Tests.”)

Please note that this is a draft guidance — the agency is accepting comments. Now is the time to help the FDA design a final guidance that will allow for both speedier approval and higher quality.

It can be done. It must be done.

Posted by Peter Pitts at 07:44 AM
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September 05, 2006

Rosetta Stone doesn't work at the Carnegie Deli

by Peter Pitts

Here’s a link to a new paper (by me) discussing how Europe can learn from America’s DTC experiences (both positive and otherwise) to create a more robust 21st century environment for patient empowerment. My premise is that health care communication is the consumer’s Rosetta Stone.

Your thoughts and comments are much appreciated.

http://www.stockholm-network.org/publications/list.php#31

Posted by Peter Pitts at 04:34 PM
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