Latest Drugwonks' Blog
Four members of Congress have introduced bills to bar drug companies from introducing generic versions of their own drugs during the time another generic firm are marketing their own version of that drug during the so-called 180 day market exclusivity period. I call it so-called because two generic companies can already share that exclusivity and it is clear that the exclusivity only applies to a generic company's monopoly relative to other firms that seek to challenge an innovator patent. Authorized generics promotes competition which is what the original Hatch-Waxman bill sought to do. Are these elected representatives now doing the bidding of "Big Generics?"
I was struck by the petulance of the response of Kurt Strange, the Annals of Family Medicine's editor in response to John Kamp's letter criticizing a "content analysis" of DTC ads (one person's opinion of TV ads in plain English):
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy...
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy...
Today's New York Times editorial, "Moving Toward Greater Drug Safety," makes some good points and some bad ones.
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
Here's why...
1.Treaties are based on trust. Thailand has violated the principle of the Doha agreement with this patent grab and in light of previous good faith efforts to negotiate partnerships with companies to promote comprehensive programs to speed access to medicines in the past, the outright seizure is akin to kicking private firms right in the ....intellectual property.
2. The patent seizure is based on a novel economic theory pursued by the not so smart Nobel Prize winner Joe Stieglitz, namely that generic companies that make drugs for profit are okay but innovator companies that do so are like Ebenezer Scrooge. That is generic companies are entitled to make a profit on drugs because they charge a "just price" for drugs but not innovator companies. Indeed, Jamie Love and others have argued that compulsory licensing should be invoked by any country, for any product, for any public use as long as a royalty is paid (just compensation).
WHO's president knows -- as does the Gates Foundation -- that the spread of this approach would leave only Jamie Love, Doctors Without Brains and a handful of generic companies in India in the business of developing new drugs for the developing world. Which means no new drugs at all.
3. The screw the drug company approach ignores the fact that most of these countries still underinvest in their public health systems and require NGO involvement above and beyond the rhetorical contributions of leftist and anti-globalist groups that have the ear of reporters at Le Figaro and The Guardian. The WHO President's rebuke of Thailand's health ministry reflects an effort the need for greater international and corporate investment and incentives to support such investment. Outright patent seizures are not an incentive the last time I checked.
1.Treaties are based on trust. Thailand has violated the principle of the Doha agreement with this patent grab and in light of previous good faith efforts to negotiate partnerships with companies to promote comprehensive programs to speed access to medicines in the past, the outright seizure is akin to kicking private firms right in the ....intellectual property.
2. The patent seizure is based on a novel economic theory pursued by the not so smart Nobel Prize winner Joe Stieglitz, namely that generic companies that make drugs for profit are okay but innovator companies that do so are like Ebenezer Scrooge. That is generic companies are entitled to make a profit on drugs because they charge a "just price" for drugs but not innovator companies. Indeed, Jamie Love and others have argued that compulsory licensing should be invoked by any country, for any product, for any public use as long as a royalty is paid (just compensation).
WHO's president knows -- as does the Gates Foundation -- that the spread of this approach would leave only Jamie Love, Doctors Without Brains and a handful of generic companies in India in the business of developing new drugs for the developing world. Which means no new drugs at all.
3. The screw the drug company approach ignores the fact that most of these countries still underinvest in their public health systems and require NGO involvement above and beyond the rhetorical contributions of leftist and anti-globalist groups that have the ear of reporters at Le Figaro and The Guardian. The WHO President's rebuke of Thailand's health ministry reflects an effort the need for greater international and corporate investment and incentives to support such investment. Outright patent seizures are not an incentive the last time I checked.
Those who think there's health care nirvana Over There, should consider this article from today's edition of the Financial Times:
NICE faces inquiry by Commons group
By Nicholas Timmins
The Commons health committee yesterday announced terms of reference for a broad inquiry into the work of NICE, the National Institute for Health and Clinical Excellence.
The committee said it wanted to examine "why NICE's decisions are increasingly being challenged" after recent controversial recommendations that the NHS should not use certain costly cancer drugs and should restrict the use of drugs to treat Alzheimer's to those with moderate forms of the disease.
The committee said it wanted to know "whether public confidence in the institute is waning, and if so why", and said it would be looking at both NICE's evaluation process and the appeal system.
At the same time it will compare the work of NICE with that of the body that is roughly its Scottish equivalent. In some cases the latter has approved treatments that NICE has rejected.
The pharmaceutical industry's concerns that the NHS fails fully to implement NICE's recommendations when it does back new treatments and procedures will also be addressed.
The committee said it wanted to look at "which guidance is acted on, which is not and the reasons for this".
NICE is currently facing a judicial review backed by pharmaceutical companies and the Alzheimer's Society over its decision on Alzheimer's products.
The society said yesterday that the inquiry "should put a long-overdue spotlight on NICE's methods" and the "glaring absence" of an independent appeals process.
NICE faces inquiry by Commons group
By Nicholas Timmins
The Commons health committee yesterday announced terms of reference for a broad inquiry into the work of NICE, the National Institute for Health and Clinical Excellence.
The committee said it wanted to examine "why NICE's decisions are increasingly being challenged" after recent controversial recommendations that the NHS should not use certain costly cancer drugs and should restrict the use of drugs to treat Alzheimer's to those with moderate forms of the disease.
The committee said it wanted to know "whether public confidence in the institute is waning, and if so why", and said it would be looking at both NICE's evaluation process and the appeal system.
At the same time it will compare the work of NICE with that of the body that is roughly its Scottish equivalent. In some cases the latter has approved treatments that NICE has rejected.
The pharmaceutical industry's concerns that the NHS fails fully to implement NICE's recommendations when it does back new treatments and procedures will also be addressed.
The committee said it wanted to look at "which guidance is acted on, which is not and the reasons for this".
NICE is currently facing a judicial review backed by pharmaceutical companies and the Alzheimer's Society over its decision on Alzheimer's products.
The society said yesterday that the inquiry "should put a long-overdue spotlight on NICE's methods" and the "glaring absence" of an independent appeals process.
I have had the chance to read both Kenzi 2.0 and the FDA's response to the scientifically illiterate IOM report. It reads like a Nobel Prize winner grading a high school essay....
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people.
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people.
The World Health Organization has cautioned Thailand over its move to adopt compulsory licensing for producing generic versions of heart disease and anti-Aids drugs.
''I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity,'' said WHO director-general Margaret Chan.
Brava!
Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.
She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue.
''I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity,'' said WHO director-general Margaret Chan.
Brava!
Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.
She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue.
Here it is, Kenzi 2.0:
Download file
It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out.
Download file
It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out.
I have Peter's back when it comes to his post on Kenzi. I wrote a piece in the Washington Times supporting the beta version of the bill and I got nothing but flack by everyone for it. I supported the bill in it's nascent form because it understood that safety and efficacy were linked and that Critical Path was, well, critical to making medicines safer as opposed to requiring mindless chain of custody and post market data dredging for every drug.
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly.
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly.
Alex Berenson, who took a leave of absence from writing fiction at the New York Times to write fiction has himself become a central character in story that I bet Alex himself wish he had written:
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts.....
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts.....