Woulda/Coulda/Shoulda

04/12/2007 07:07 AM |

People keep telling me that the only major difference between the "first 100 hours" House bill on the abolition of non-interference and the Senator Baucus' pending piece of legislation is that the the House bill says that the Secretary "shall" and the Baucus bill says that the Secretary "can."

No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.”

Well said,but there's something else -- comparative effectiveness.

Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.

Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.

How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
  Read More & Comment...

OxFam's Dubious Double Standard on Israel and Thailand

04/12/2007 04:20 AM |

In 2002, Oxfam International announced a boycott of Israeli goods grown or manufactured in what its literature refers to as the "occupied territories." Last year it blamed Tony Blair for his one sided support of Israel in it's war against Hezbollah. Now of course it supports the Thai dictatorship's effort to seize the IP of drug companies even as they give away free drugs to poor countries.

Just my effort to maintain moral clarity.  Read More & Comment...

insect technology

04/11/2007 02:24 PM |

an interesting study about one of a new wave of vaccines for influenza. I am glad to see the move starting away from egg-based technologies to more genetic technologies. It will enable us to respond to an emerging virus rather than have to anticipate one. I am quoted accurately on this here in the HealthDay piece about it:

http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html  Read More & Comment...

Dem Bones

04/11/2007 12:38 PM |

Catch the last episode of "The Sopranos?" Yeah, the one where Tony and crew go to Canada and discuss how they can make a pile of dough by importing fake/expired Fosamax.

Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.

Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.

Bada Bing!

We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.  Read More & Comment...

Plan B+

04/11/2007 12:02 PM |

On April 9th the New York Times editorial page weighed on the issue of subsidized contraception for university students:

“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.”

“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.”

“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.”

“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.”

Spot the inconsistency?

How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?

This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.

But you can’t have it both ways.

Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.

But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.

(And there isn't.)  Read More & Comment...

PBM(J)

04/11/2007 10:41 AM |

Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.

PBMJ = Prescription Benefit Misjudgment.

At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.

At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.

Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.

This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.

Net/Net: a back-door route toward a VA-type pricing system.

Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.  Read More & Comment...

AdCom-ical If It Weren't True

04/11/2007 03:30 AM |

This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:


Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.

"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.

Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.

The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.

A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.

The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.

According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.

The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."


So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?

We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?

The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.  Read More & Comment...

Comparative Effectiveness: Life vs. Death

04/10/2007 08:00 PM |

Rule Britainia? Time to change the rule.

From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.

Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS

10th April 2007

Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.

The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.

But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.

Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.

Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."

Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.

NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.

Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.

Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.

"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."

Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.

Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.

A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.

It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.

"The North Staffordshire guideline will be reviewed in the light of its results."

The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.  Read More & Comment...

The New Republic Sounds Old and Tired on Health Care

04/10/2007 03:18 PM |

http://www.tnr.com/doc.mhtml?i=w070409&s=cohn041007

According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....

"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "

Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.

Oh.

Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).

Oh.

There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.

Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?

If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.

America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.

Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.

Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.


As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.  Read More & Comment...

"Des-Pearate" Measures: NYT Mischaracterizes FDA's Woodcock on FOBs

04/09/2007 03:31 PM |

In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.

Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''

Woodcock said nothing of the sort. Here is what she said:

"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."

Here is a link to Dr. Woodcock's testimony.

http://www.fda.gov/ola/2007/protein32607.html

Pear thinks it gave legislation for FOBs an "unexpected boost."

Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.  Read More & Comment...

FDA Reform: A Pet Project?

04/06/2007 08:20 AM |

Much chatter about contaminated pet food.

Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.

The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.

Penny wise and pound (no pun intended) foolish? Neither. Dangerous.  Read More & Comment...

the plight of smokers

04/05/2007 06:50 PM |

I'm looking forward to the results of the NIH trial, but I don't think there is truly much controversy about the usefulness of this test, esp. in the right hands.

Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health

But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.

Here's an interesting study just published - the mention is in Cancer Research UK:

Lung cancer screening effective for high-risk groups, says US group

FRIDAY 30 MARCH 2007

Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.

The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.

A total 124 of these people were diagnosed with lung cancer.

Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.

Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.

The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.

Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.

"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.

The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths.  Read More & Comment...

French Twist

04/05/2007 10:22 AM |

I've just returned from a breakfast (kindly organized by the Government of France) with seven leading French journalists. The topic: health care. Needless to say, it was a wide-ranging conversation. A few items of note:

(1) My French is really rusty.

(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.

(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.

(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.

(5) And we talked about patient information. Empowering the consumer? Mon Dieu!

(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.

(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)

But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.

And, no matter what language you're speaking, it sure sounds familiar.  Read More & Comment...

Barack's Obysmal Health Care Meeting

04/04/2007 02:36 PM |

"We all do no end of feeling and we mistake it for thinking. And out of it we get an aggregation which we consider a boon. Its name is public opinion. It is held in reverence. It settles everything. Some think it is the voice of God."

Mark Twain

I was going to download a webcast of Barack Obama's community meeting on healthcare in Seacoast, NH but found a newspaper account first. I am glad I did not waste the bandwidth.

If it was a battle between being banal (Barack) or bereft of insight (the attendees from Seacoast) they would still be slugging it out for first prize.

How do the Seacoasters and Obama fare? Let's restage it as drama:

Barack:"When I take office, I have to feel I have a mandate for change."

Laurie MaCray: "I don't want anymore competition - it's too confusing, it's trying to compare apples and oranges,I want a system with no deductibles, no co-pays. I want a national standard that insurers have to adhere to or not sell insurance."


Richard Friedman, MD "The problem is overuse of testing and high-priced drugs."

"We don't care how the system is managed as long as it is affordable and accessible to everyone."

Obama: ""Ultimately, (my plan) will be my best take on a comprehensive health care policy.

"I'm not going to be able to do this by myself."

My advice. Don't count on Seacoast for direction.

PS. Isn't that what people are electing YOU for?  Read More & Comment...

drug resistance - flu drugs

04/04/2007 12:09 PM |

Here's an interesting story by the Healthday reporter which was published in the Wash Post, Forbes, and several other places.

I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.

Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html  Read More & Comment...

Selective Transparency

04/04/2007 10:21 AM |

An editorial in today’s edition of the Minneapolis Star Tribune calls for consumers to “weed out conflicts in prescription drugs.”

According to the Star Tribune ...

“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.”

Talk about a loaded question!

But wait, it gets worse. The editorial continues …

“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.”

But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor” that offers, among other suggestions, “best buys” for Alzheimer’s medications.

An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?

Here’s a link to the full editorial:

http://www.startribune.com/561/story/1098522.html

If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.  Read More & Comment...

Aging Matilda

04/03/2007 09:27 AM |

A new Austrailian report estimates that government spending on the private health insurance rebate, which costs about $3 billion Aussie dollars a year, will grow at 4.4 per cent a year -- nearly three times the expected real growth of the economy over the next 40 years.

Sound familiar?

The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."

"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.

Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?

The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.

(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)

Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.  Read More & Comment...

zelnorm

04/02/2007 12:34 PM |

I don't want to say too much about this until the smoke clears, but some early observations:

1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.

2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.

3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?

it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.  Read More & Comment...

Sometimes Safety

04/02/2007 11:03 AM |

Can drug safety be a sometimes thing?

I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see yesterday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.

(Remember, don't call them generic biologics. Words count.)

These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.

Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?

Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.

Sorry fellas -- ain't that easy.

I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.

Yup -- zero.

The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.  Read More & Comment...

Doubting Tomas

04/02/2007 10:34 AM |

Regular readers of DrugWonks.com know that when pundits and pols call for FDA reform, we urge them to "Show me the money" that such efforts deserve. Mostly, we're still waiting.

Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"

He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.

Here's a link to the editorial:

Download file

Thoughts and comments appreciated.  Read More & Comment...