Pfizer Connects the Dots

06/11/2008 05:36 PM |

Pfizer will directly fund basic research in an open-ended collaboration with Univ of Calif San Francisco..I hope this gives the connect dots crowd angina (that drugs developed through this deal with Satan can treat) so that they in turn can refuse them based on the Pharmalot principles:

1. Any drug developed by a collaboration with BIG PHARMA is by definition less effective and more dangerous than literature and FDA documents state and is more dangerous and less effective than bloggers, trial lawyers and unbalanced patients proclaim.

2. Any older drug is safer and more effective than any newer drug even though every older drug was developed in the same fashion as newer drugs.

3. Newer drugs are more dangerous and less effective older drugs because older drugs are made by generic companies who don't market products and newer drugs are approved by an FDA run by a Bush administration appointee.

4. Any research produced by anyone who has ever consulted with or conducted research for a biotech or pharmaceutical firm is tainted and the results, though reproduced and validated by scientific methods, are false.

5. Except Steve Nissen.


6. Or Curt Furberg

www.sfgate.com/cgi-bin/article.cgi

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The Wearin' o’ the Vermillion

06/11/2008 12:57 PM |

The Wall Street Journal reports that, “The criminal-investigations wing of the Food and Drug Administration is in hot water with Democrats and Republicans in both the Senate and the House.”

That would be the he Office of Criminal Investigations, the OCI. It seems that many of the usual suspect FDA-bashers (Senator Grassley, Mr. Stupack, Mr. Barton) are “concerned” that the OCI is being pressured to pursue some cases (like the abuse of scheduled medicines such as Oxycontin or ingredients for methamphetamine) while ignoring others (like the brouhaha over Ketek clinical trial oversight).

Why would the OCI focus on the former rather than the latter? Hint: Much larger public health issues. Why would some politicians want the OCI to reverse its priorities? Could it be … politics? After all, bashing Big Pharma (or, if you prefer, Big Pinata) is much sexier, garnering much bigger headlines.

It's also important to mention the OCI's central role in fighting counterfeit drugs (aka: international healthcare terrorism). But saying "thank you" isn't in the current Congressional lexicon. Too bad. OCI's earned it many times over.

According to the Journal, “Mr. Grassley has already cut into OCI's autonomy. For nearly a decade, OCI worked under a little-known memorandum of agreement that gave OCI precedence over the Inspector General's office at Health and Human Services Department in conducting internal-affairs cases. That authority was withdrawn at the end of 2007 after Mr. Grassley complained that OCI selectively investigated FDA whistleblowers.”

There’s a difference between whistleblowers and felons. Note: Releasing internal FDA documents to the media is a felony.

As if the slight to the very hard working and dedicated OCI staff wasn’t bad enough – the WSJ article singles out the OCI’s director, Terry Vermillion, for particular abuse.

“Mr. Vermillion hasn't been made available for interviews. He came under fire from Democrats and Republicans last year when news reports revealed that large bonuses pushed his take-home pay for 2006 to $198,000, more than that of a member of Congress or a Supreme Court justice."

Note to Alicia Mundy: What about all those Congressional perks? They sure add up --and quite nicely. FDA perks are restricted to parking spaces at HQ. Sloppy reporting. (I assume the Supremes must have pretty nifty perks too.)

Terry is a tough mother you-know-what. Precisely the kind of guy you want running the FDA’s Office of Criminal Investigations. And I say that from personal, first-hand knowledge and experience.

And he’s got a BS tolerance about the size of a pea. Anybody who would be foolish enough to tell him to selectively do his job would be in for a very unwelcome and brutal surprise.

Another shameful show trial? Yes. But what’s worse is that it continues to erode FDA morale and dampen esprit de corps -- just at a time when the agency (and the country) needs it more than ever.

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Tabloid Medicine: The Prequel

06/10/2008 01:24 PM |

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Prescription for Paperwork

06/10/2008 12:42 PM |

As Albany considers healthcare reform, CMPI Chairman, Dr. Michael Weber warms that the unintended consequences may very well be a prescription for paperwork trumping public health.

Here are the first two paragraphs from his op-ed in today’s edition of the New York Post:

“FEW relationships are more personal - and private - than the one between patient and doctor. Unfortunately, this fact appears to be lost on New York's politicians.

Gov. Paterson is now backing legislation designed to limit the influence drug companies wield over doctors. The goal may sound reasonable - but the bill itself would bring a massive and unnecessary government intrusion into individual medical decisions.”

Click here for the complete article

To see Dr. Weber discuss this and similar issues on a recent CMPI video podcast, click here:

http://www.vimeo.com/1045899

As Dr. Weber writes, “Gov. Paterson means well in promoting these "reforms" - but he's wrong. The bill would only drive up medical costs by producing reams of added paperwork for doctors, patients and administrators alike.”

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Money talks. Healthcare walks.

06/10/2008 12:30 PM |

Last week I attended a conference of European pharmaceutical executives, legislators, and regulatory officials.  The theme was “Economics and Ethics.”

 
While the “universal” consensus was that ethics are primary – economics came in a very close second.  One robustly debated theme was the idea of “an ethical standard based on resources.”

In other words, reality.

 We live in the real world where increasing drug development costs and shrinking resources for reimbursement (government-paid in the case of the Europeans) cannot be ignored when it comes to either green-lighting a development program or making an access decision based on healthcare technology assessment (HTA).

One leading consultant suggested that pharmaceutical development program should not proceed beyond Phase II until the company met with reimbursement agencies to gauge the likelihood of a positive coverage decision based on clinical endpoints.

Frightening that such a highly paid consultant could so completely miss the point – that government healthcare systems exist to serve their citizens, not to act as actuarial bean counters.  Financial prudence?  Cetainly.  But not at the expense of the right medicine for the right patient at the right time.  That’s a medical decision. That’s ethics.

Many present pointed out that what we really need are better tools to allow smarter development programs that don’t fail in late Phase III (as over 50% do today).  In the US that means the Critical Path.  In Europe it’s the Innovative Medicines Initiative.  Both are predicated on patient-centric care.

But when a healthcare system is a government-pay model, the cost-based versus patient-centric momentum seems unstoppable.

Consider the remarks last week of Thomas Lonngren, executive director of the European Medicines Agency (EMEA),

 "It could come to a situation where we are approving a product based on efficacy, safety and quality ... but the patient can't get it because the health technology institute says it is not cost-effective."

 Note to Tom – already happening.

Consider Britain's National Institute for Health and Clinical Excellence (NICE) and the series of high-profile disputes in which new drugs for conditions such as cancer and rheumatoid arthritis have been turned down for use on the state health service.

And what’s worse than a bad decision in one country?  Correct – a cavalcade of uncoordinated, voodoo cost-based decisions -- with one even less patient-centric than the last. Or, as Lonngren commented,

 "… a different decision in each member state (of the European Union) because this is not harmonized.”

Other countries, including Germany, have recently set up their own versions of NICE and Lonngren said the emergence of such health technology institutes posed a challenge for drug manufacturers since these bodies often required additional research, and he suggested there might be scope for cooperation with the EMEA in designing drug approval programs in future.

Is that a good idea, EU harmonization of HTA? Or is it the camel getting its nose under the tent?

That, ladies and gentlemen, is the distinction between “universal” healthcare and “government” healthcare.  In short –no difference at all.

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Another Way of Looking at the Grassley Knoll

06/10/2008 12:48 AM |

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Forms & Function

06/09/2008 12:54 PM |

The New York Times reports that,

"A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators."

Point One: How did a phrase like "fuel an explosion" make it past an editor? This is journalism?

The Times continues,

"By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants."

Okay - that's the genesis of the story - Drs. Biederman and Wilens didn’t fill out their disclosure forms properly. They should know better. Transparency is a serious business that needs to be taken seriously - and they deserve to be taken to task for their bureaucratic ineptitude.

That's what Senator Grassley is upset about - and it serves as a timely anecdote in support of the physician sunshine legislation he's pursuing. But there are other agendas at play here - and Senator Grassley is being played (unwittingly one hopes) like the proverbial violin. When it comes to Conflicts of Interest, its COI polloi.

The not-so-hidden agenda is that anyone who supports the use of psychiatric pharmaceuticals for any reason needs to be humiliated and destroyed.

In that respect this is all about a new definition of R&D. Now it means RICO and Destruction.

Here's how the Times smoothly segues into this, far more nefarious story,

"The Harvard group's consulting arrangements with drug makers were already controversial because of the researchers' advocacy of unapproved uses of psychiatric medicines in children."

Already controversial? Really? According to whom? The Times doesn't every really say. The article's only mysteriously refers to”experts," as in "experts say." Maybe they're part of the New York Times expert witness protection program.

And the one person they do quote represents an activist group with an anti-medication agenda,

"Longtime critics of the group see its influence differently. "They have given the Harvard imprimatur to this commercial experimentation on children," said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group."

This despite the fact that deeper in the story the Times casually mentions that, "The Grassley investigation did not address research quality."

There's a lot of that going on. A lot of what the Grassley investigation did not address. To wit, the Times adds that, "Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money."

And consider this paragraph,

"In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists; their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen."

Another example of amazingly bad editing. Marketing department "brethren?" "Terrific pitchmen?" Do these words belong in a news story outside of third party quotations?

Somebody should bring this to the attention of the New York Times Ombudsman.

The goal of Vera Sharav and her "brethren" is to scare away any research grants from anyone who supports the use of pharmaceutical treatment for psychiatric disorders. Let's face it, this story didn't come up because Senator Grassley's staff was looking at disclosure forms alphabetically and just happened to reach the Bs. There's no such thing as a coincidence when it comes to an opportunity to attack top tier researchers who accept pharmaceutical industry funding.

Unable to win on merit, activists go to motives. And the article seems to fall all over itself going back and forth between referring to how "world renowned" Bierderman and Wilens are while repeating and magnifying the insinuation made by the skeptics that, "for money," world class researchers are willing to aid and abet greedy pharmaceutical companies, "disease mongering" to create a Brave New World.

Here's a link to the complete story:

http://www.nytimes.com/2008/06/08/us/08conflict.html?scp=1&sq=biederman&st=nyt

Harvard Medical School has a new dean, and it'll be interesting and informative to see how he deals with this -- defend his faculty or go the PC CYA route. The pro forma response of most academic institutions (Mass General included) has been to hunker down when members of their own faculty are insulted by activists and the news media – letting them take the abuse in silence rather than vigorously defending them. We'll see.

Consider the comments of the only named "expert," Dr. E. Fuller Torrey, the executive director of the Stanley Medical Research Institute. It isn't even a comment on the quality of the Biederman/Wilens research. "In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money."

Certainly more money is needed - but why is government money any better than industry money? Should perception, rather than data, drive science? That's the agenda. It's frightening.

And so is McCarthyism.

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The McCarthyite Mugging of Joe Biederman

06/08/2008 05:44 PM |

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The Counterfeiting Superhighway

06/06/2008 11:02 AM |

Yesterday, in Washington DC, I spoke at the Fourth Global Forum on Pharmaceutical Anticounterfeiting.  My talk was why we won’t see legalized drug importation after the November elections – regardless of who gets elected.
 
There are four basic reasons:

(1)    It won’t save any money.

(2)    The drugs being sent to U.S. customers from Canadian Internet. pharmacies are not “the same drugs Canadians get.”

(3)    The state experience has been dismal and politically embarrassing.

(4)    National Security concerns.

(For more detail on these points click here:   www.drugwonks.com/blog_post/show/5011)

Adding fuel to the reality is a new report just made public at the conference, by the European Alliance for Access to Safe Medicines (www.eaasm.eu).  The title says it all, “The Counterfeiting Superhighway.”

The report reveals the scope of the unregulated trade of fake pharmaceuticals. Through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines, the report makes one thing very clear – we’re not winning the battle.

Key findings from this report

•    62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).

•    95.6% of online pharmacies researched are operating illegally.

•    94% of websites do not have a named, verifiable pharmacist.

•    Over 90% of websites supply prescription-only medicines without a prescription.

•    78.8 of websites violate intellectual property.

My favorite anecdote is the report’s example of an Internet pharmacy whose products came wrapped in pages from the Mumbai Daily News.  The most frightening fact, though, is most of the fake medicines “were delivered in seemingly authentic boxes, accompanied by patient information leaflets in good condition and ostensibly trustworthy blister packs.”

The report concludes by providing recommendations based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators, to take action and halt this dangerous trend.

Bravo. 

The full report can be found at www.eaasm.eu/Media_Centre/News/The_Counterfeiting_Superhighway)

Drug importation is not on their list of solutions.

The take-away for U.S. electoral rhetoric is obvious – Senator McCain and Senator Obama cannot be for enhanced drug safety and for drug importation.  It’s simply does not compute.

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Is Preemption just a lot of Palloney?

06/05/2008 09:24 PM |

According to a spokesperson for House Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., he and House Oversight and Government Reform Chairman Henry Waxman will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients' ability to seek damages under state law.

"Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries,” Waxman said during a hearing last month on issue. "The result is that one of the most powerful incentives for safety -- the threat of liability -- would vanish."

Okay – once more with feeling, not true. When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, federal preemption does not protect the manufacturer – and they should be held accountable. The threat of litigation can be an important disincentive to such irresponsible behaviors.

The U.S. Chamber of Commerce's Institute for Legal believes that federal law should trump state statutes when there are inconsistencies between the two. It further argues that preemption allows companies that conduct business in different states one set of rules for compliance, instead of a hodgepodge of laws that stifle growth.

As it should be.  Why make being “in compliance” difficult.  Doesn’t that ultimately hurt consumers?

An important point to remember is that The FDA’s legal authority over labeling for prescription drugs and biological products is plenary.  The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements.  Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.”  In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.

There is some hope for sanity.

"Current preemption policy is nothing novel or radical, but a dynamic response to an increasingly litigious environment that undermines the effectiveness of the long-established FDA regulatory system," said House Oversight and Government Reform ranking member Tom Davis.

Amen.

Watch this space for more details.


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Are Liberals Trying to Kill Ted Kennedy?

06/05/2008 07:22 PM |

Here’s the lead paragraph from Bob Goldberg’s op-ed in today’s New York Post:

“IRONICALLY enough, the dangers of the liberal health-care agenda are being made clear by the care that a liberal icon, Sen. Ted Kennedy, has received since his brain seizure last month.”

And here’s a link to the complete article:

Read New York Post article

A worthwhile and disturbing read.

Caveat Emptor.  Read More & Comment...

ShannonCare

06/05/2008 02:49 PM |

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Credit Where Credit Is Due

06/04/2008 01:20 PM |

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Is a puzzlement

06/04/2008 10:44 AM |

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.  Read More & Comment...

Visits to the spin doctor won't help

06/04/2008 10:00 AM |

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.  Read More & Comment...

God's Speed, Patty Delaney

06/03/2008 06:44 PM |

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.

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Sid Wolfe on Speed (dial)

06/03/2008 01:38 PM |

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.

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What Mark Thornton Did Not Disclose

06/02/2008 09:52 PM |

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Clarification from the Grassley Knoll

06/02/2008 08:19 PM |

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.)

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A Liberal Life is Worth Saving

06/02/2008 04:08 PM |

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