Credit Where Credit Is Due

• 06.04.2008

Is a puzzlement

• 06.04.2008

I am not making this up. According to a new report in the Bangkok Post, “Priority is being given to promoting biotechnology by the Science and Technology Ministry, which sees the technology as a potential tool to give the economy a much-needed boost.”
Yes – this is the same government that flaunts its disregard for intellectual property rights for, you got it, biopharmaceutical companies!

As Yul Brynner commented in The King and I, “is a puzzlement.”

The ministry's announcement of its pro-biotechnology policy came ahead of the June 17-20 Convention of the Biotechnology Industry Organizations (BIO2008) in San Diego.

Satit Chanjavanakul, secretary-general of the Office of the Board of Investment, said the office has already granted investment privileges worth over 19.5 billion baht to about 45 biotech companies.

''We are trying to attract more investment in this promising field by offering tax privileges to any company investing in biotechnology research and development,'' he said.

Okay, three questions:

1. Is the ministry oblivious to or ignorant of what investors in the biotech sector seek and need-- like the primacy of IPR for innovative research?

2. Is the ministry unaware of the high profile compulsory licensing done by their own health ministry? Is this possible?

3. Or is this effort just a form of (very cheeky) damage control?

Let’s go with cognitive (cheeky) dissonance as in, “Yes, you as an investor are vulnerable to us seizing your property. And, yes, please come and transfer your technology, invest in our country, because we are offering certain advantages to you!"

If Thailand wants to become a biotech hub, they’re going to have to do more than … whistle a happy tune.

Visits to the spin doctor won't help

• 06.04.2008

Hopes were high as Nicolas Sarkozy sailed into high office a year ago. An impressive agenda and a multitude of seemingly radical proposals formed a manifesto for change, even « rupture », ie a radical break with past policies. Failure was not an option.

Today, accounts and results are far from conclusive ; and this includes healthcare policy where reform is largely non-existent ; words are not deeds.

A recent article in the Quotidien du Médecin (weekly for health professionals) wrote last week : « Indeed, the system of co-payments, vigorously opposed by public opinion, has been implemented but that’s about it. For the rest – be it hospitals, private sector physicians, financing of the public health insurance or the announced revolution through regional health authorities – we are kindly asked to await the autumn or even 2009. »

Well said. In truth, any wholesale reform of « the world’s best system » will have to tackle awesome vested interests, both private and public. Which is why the government is loath to launch any radical initiatives. As in education, the nominal « private » sector remains heavily tied to state authorities. And although reports have shown, quite recently, that productivity is substantially higher in the private hospital sector, the administration consistently squeezes private provision of health care.

And as for being world champion a couple of years ago (in the EHCI index:

www.healthpowerhouse.com/archives/cat_media_room.html

France slipped to third place this year. Something is happening ; let’s hope policy makers have noticed.

God's Speed, Patty Delaney

• 06.03.2008

Sad news is no less sad when you know its coming.

Patty Delaney has passed away. Her 20-year battle against cancer was as epic as it was public. But it was never about Patty.

For Patty it was all about every other cancer patient. To say that her job as the FDA’s Office of Special Health Issues Cancer Liaison was “more than a job but a calling” is too trite and does not do justice to the woman and her warmth, her professionalism and her tenacity.

And her depth of caring. And her intensity. She was a pit bull. She was profoundly dimensional. Her legacy is breathtaking. We must all strive to live up to it -- and not let her down.

Writing about her in the past tense is painful.

God’s Speed, Patty Delaney.

Sid Wolfe on Speed (dial)

• 06.03.2008

Much ado about pharma freebies to physicians. Much ado about nothing medically. Much ado about everything politically. And the media is the message.

Witness today's story about romancing medical students.

The New York Times reports that, “Most medical schools the United States fail to police adequately the money, gifts and free drug samples that pharmaceutical companies routinely shower on doctors and trainees, according to a ranking by the American Medical Student Association."

According to Dr. Brian Hurley, president of the AMSA, “These policies are incredibly important to protect the educational experience students have at school and the quality of the education they’re getting.” The Times reports that, "Schools that shield students from marketing messages will produce doctors who provide better care to patients, Dr. Hurley said."

Really? Why is that? No evidence provided. Just empty rhetoric but, since it’s in the New York Times, fit to print.

The Times’ story continues, “The role played by pharmaceutical and device makers in the education of doctors has become an increasingly controversial topic, with some top medical schools placing a growing number of restrictions on the longtime practice of providing free food, gifts and educational seminars to trainees.”

But, again, no facts to show why this isn’t anything more than a tempest in a teapot being brewed by the usual suspects.

And, speaking of the usual suspects – guess what public policy expert the Times quotes on the matter? Yup – Sid Wolfe.

“Most of the medical school bureaucracies are getting too much money and other forms of largess from the drug industry to initiate these healthy, long overdue policies on their own,” Dr. Wolfe said.

Here’s a link to the complete story in today’s Times:

http://www.nytimes.com/2008/06/03/health/03conflict.html?ref=health

Where’s the other side of the argument? Invisible in today's New York Times, but it’s there. It’s important. It’s not hiding. In fact, it’s easy to find and high profile.

Consider the recent op-ed in the Boston Herald by Dennis Ausiello and Thomas P. Stossel (both of Harvard Medical School). And then consider what they have to say on the topic – balderdash!

In their own words,

“The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry. We strongly oppose this agenda.”

“… Despite extensive training, physicians cannot know the details of all products, especially new ones. Therefore, company salespersons complement physicians’ information derived from many sources. They tell physicians about a limited range of products about which their employers train them under strict FDA regulations.”

“… We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps.”

Here’s a link to their complete op-ed:

http://bostonherald.com/news/opinion/op_ed/view.bg?articleid=1087609

It wasn’t hard to find. In fact, it was made easier by the fact that Dr. Stossel testified in front of Congress on this issue – recently.

Having Sid Wolfe on speed dial may be easier, but it doesn’t lead to better, more balanced or informative reporting.

What Mark Thornton Did Not Disclose

• 06.02.2008

Clarification from the Grassley Knoll

• 06.02.2008

Dr. Mark Thornton, in a recent Wall Street Journal op-ed, wrote that Senator Charles Grassley, "is demanding a full-scale review of each and every product ever approved," and is asking for a rejudgment by GAO "to ensure that drugs approved on surrogate endpoints are both safe and effective."

Which caused the following clarification from the senior senator from Iowa,

"Surrogate end points are a valid way for the FDA to approve drugs."

Thanks to Mark (a CMPI board member), Senator Grassley was forced  to admit that 21st century science is appropriate for the regulation of 21st century medicines.

When it comes to advancing the public health, there shouldn't be any room for political rhetoric.

(But, alas, we live in the real world. All the more reason to call it like we see it.)

A Liberal Life is Worth Saving

• 06.02.2008

Weak End at Bernie's

• 06.02.2008

According to an article in livemint.com (the Wall Street Journal’s news partner in India), “For the first time ever, a consensus has evolved on creating global patent databases, monitoring drug prices and encouraging companies to differentially price their drugs, as a burgeoning health care bill pushes governments towards sourcing cheaper medicines.”

The initiative, part of a draft agreement adopted by all the countries in the World Health Assembly in Geneva recently, has been “cheered by public health advocates and makers of generic or off-patent drugs.” The assembly is an apex group of member nations at the World Health Organization or WHO.

The health assembly has, in its draft, also asked member nations to “encourage pharmaceutical companies and other health-related industries to consider policies, including differential pricing” to promote availability of affordable drugs and consider “development of policies to monitor (drug) pricing.”

The concept of differential pricing has been kicking around for some time with some success. Now, together with an up-to-date patent database, we should expect to see more of it. Most people think this is a good idea.

Novartis India Ltd's managing director Ranjit Shahani, who was the president of Organization of Pharmaceutical Producers of India, a lobby of foreign-owned drug makers in India, called differential pricing “directionally positive” and ones that recognize people's varying paying capacity, though the implementation should be through a workable model.

But not everybody is happy.

The clause for “drug monitoring” has failed to impress those of the Jamie Love school of “prizes for patents.” “Monitoring prices is a good step but controlling prices would have been a better and stronger one,” said Kajal Bharadwaj, a lawyer specializing in drug access-related patent issues and added that the health assembly text “legitimizes and validates the public health hedges in government policies that countries like India, Thailand and Brazil have been sticking up for”.

Actually, that’s not true. Clearly Ms. Bharadwaj would like it to be true and so, in typical Big Lie fashion, she will simply keep saying it’s true. This is the same tactic Jamie Love uses when he tells people in Europe that legislation in the United States calling for prizes to replace patents is going to become the law of the land. (FYI – this bill was authored by Senator Bernie Sanders, the Socialist Senator from Ben & Jerry’s and has, as of this writing, zero co-sponsors.)

Here's the complete livemint article:

www.livemint.com/2008/06/01232744/Draft-WHO-pact-on-drugs-cheere.html

"Page" Turner

• 06.02.2008

A few weeks ago I was on a panel with J. Rick Turner, Chairman of the Department of Clinical Research and Director of the Cardiac Education Center at the Campbell University School of Pharmacy.  And, as usual, the most interesting part of the conversation happened after the panel was over.

As we were gathering our papers and checking our blackberries, Dr. Turner mentioned that he had written a new book on the issue of “integrated cardiac safety.”  I asked him to send me an advance copy.  And he did.

They don’t call him “Page” Turner for nothing.

His new book, “Integrated Cardiac Safety:  Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Post Marketing Surveillance,” is a timely and important addition to the debate over drug safety and, equally important, safe use.

Consider the following brief excerpts:

“A drug’s development in the sense of improving its safety and/or effectiveness profiles does not stop at the point of marketing approval.  Data collected during the drug’s use in large patient populations can lead to meaningful improvements in the drug.  This term, lifecycle drug development, therefore emphasizes that it is vital to remain vigilant about the drug’s effects from the very beginning of the drug discovery phase throughout the entire time that the drug is on the market and hence available for prescription to patients, and it captures the spirit of this book very well.”

“So too does the term integrated cardiac safety.  A central tenet of this book is that it is beneficial to discuss the assessment methodologies used to collect information on cardiac safety at four stages of lifecycle drug development—drug discovery and design, nonclinical development, preapproval clinical development, and postmarketing surveillance—in one book, and to integrate this information to the greatest degree possible.” 

“Meta-analyses vary in the number of patients included since this is dependent on the numbers in the individual trials combined in the new analysis.  However, typical numbers are also in the thousands. However, it is fair to say that statistical methodology is currently less well developed in the case of epidemiology studies than it is for randomized controlled trials: this is not meant as a pejorative statement, simply a statement of the current state of affairs that will hopefully and very likely change as additional spotlights on and developments in the field of pharmacoepidemiology increase.”

“It should also be noted here that the term nonexperimental is not a pejorative one compared with the term experimental.  Piantadosi discussed two fundamental types of study design, experimental and nonexperimental.  In experimental studies participants receive random treatment allocation, and observations are made under conditions in which the influence of interest is controlled by the research scientists.   In nonexperimental studies the research scientist also collects observations but does not exert control over the influences of interest.  Nonexperimental studies are often called ‘observational studies,’ but this term is inaccurate: it does not definitively distinguish between nonexperimental studies and experimental studies, in which observations are also made.”

The book, due out in November of this year is must reading – especially for Steve Nissen.