NIH Gives Colleges Cash To Act More Like Drug Companies

10/05/2006 03:40 PM |

Is it just me being cynical or is it my post--Yankee loss crankiness but isn't the NIH award of $500 million over 5 years to 12 universities to help them work together in order to come up with validated therapeutic targets and conduct outcomes studies based on mechanistic research generating more headlines than the news merits.

It's not just because the amount pales in signficance to what drug and biotech companies spend doing exactly what the NIH grant is, in part, supposed to do: pooling data, enrolling people in studies more quickly. (Where is the demand to have academics post their clinical trial data on a website for the world to see?)

Nor is it because the money seems to be going to fund exactly what the academic medical centers are already doing, except they will hold more conferences where people can squabble over control over data. For instance, according to the Sacramento Bee

"UC Davis plans to use the funds to expand clinical trials for people with cancer, infectious diseases, vascular diseases and neurological conditions including Alzheimer's disease and spinal cord damage, said Dr. Claire Pomeroy, vice chancellor and medical school dean.

Beyond clinical trials, it will also look for ways to ensure that the newest advances in treatment are spread throughout the community, so that underserved populations also can benefit"

Sounds great, but a business plan or opportunistic driven research agenda it ain't.

Perhaps it is because the phrase "translational medicine" has become the cool buzz word of those seeking additional NIH funding and twist it to mean anything and everything.

That fact is, we have a translational medicine problem in academia and it consists of NIH researchers and academics knowing next to nothing about drug development or the quality of data it takes or the medicine chemistry required to actually get a drug ready for human trials. Academia and NIH are awash in novel targets -- as are drug companie -- but in academia everyone thinks their compound is going to be grand slam when in fact they strike out more often than not.

And for VC and biotech firms, the reluctance to fund academic research is not just the prima donna behavior on the part of potential partners, it is the fact that most compounds or potential products are not far enough along the development continuum to know if they will work or not...The real translational work in an era of targeted medicine will take place in a new drug development paradigm where academia and companies work more closely -- in cooperation with the FDA -- to revamp the drug approval path consistent with what is known about medicine from the mounds of prior clinical experience and biomarker validation.

The fact is, the real barriers to translational medicine are the product of failing to apply cutting edge science to today's drug development regulations. So for David Kessler -- the former FDA commish who is now dean of the UC medical school to say that there are"not enough people who are pursuing research that connects the dots between what is done in our basic science labs and what can directly benefit patients." is galling. It was he who made it harder to bring medicines by opposing the introduction of science based changes to FDA processes permitting accelerated approval. There are plenty of people...but not enough dots. That's a political problem perpetuated by people like Kessler, Grassley, Waxman, etc.  Read More & Comment...

Ben “Dr. Doolittle” Bernanke

10/05/2006 08:26 AM |

Did you know that Federal Reserve Chairman Ben Bernanke can talk to the animals? Specifically the 800-pound gorilla in the room – our aging baby boom generation.

Yesterday he addressed the issue that unless Social Security and Medicare are revamped, the massive burden from retiring baby boomers will place major strains on the nation's budget and the economy, said Wednesday.

"Reform of our unsustainable entitlement programs" should be a priority, he said in remarks to the Economics Club of Washington. "The imperative to undertake reform earlier rather than later is great," Bernanke added.

Bernanke suggested that, as the population ages, the nation will have to choose among higher taxes, less non-entitlement spending by the government, a reduction in spending on entitlement programs, a sharply higher budget deficit or some combination thereof.

Government spending on Social Security and Medicare alone will increase from about 7% of the total size of the U.S. economy to almost 13 percent by 2030 and to more than 15% by 2050, he said. Bernanke declared: "The fiscal consequences of these trends are large and unavoidable."

There are two additional crucial options we must aggressively pursue to address these generational and budgetary inevitabilities, (1) shift our public health paradigm from acute to chronic care and, (2) create more robust public health information campaigns focused on disease states that can be avoided/delayed through changes in lifestyle (for example diabetes, obesity, and cardio-vascular disease).

How? Many ways, including more robust personalized medicine, development of ever more targeted therapies, science-based prophylactic interventions (i.e., statins), and smart, well-funded, and prolonged public information campaigns funded by government and private industry -- both together and separately.

We must design and implement a 21st century baby boomer health care manifesto.

Can we do this? We must.  Read More & Comment...

David Vitter comes out of his shell

10/04/2006 09:31 AM |

Our pal Anna Mathews at the WSJ reports today that “When Andrew von Eschenbach, the acting head of the Food and Drug Administration, paid a courtesy visit to Sen. David Vitter last spring, the Louisiana Republican zeroed in on a key issue: What is the agency doing about little turtles?”

(Turtles often carry salmonella in their digestive tracts. Infected turtles can convey the bacteria to their eggs. The FDA also restricts the sale of turtle eggs in the U.S. Though bacteria-carrying turtles may not show symptoms of illness, they can spread salmonella to their handlers. Ingesting it -- typically, after failing to wash hands after playing with a turtle -- can lead to vomiting, fever and cramps, even death in vulnerable patients. After the 1975 restriction, turtle-related infections appeared to nearly vanish.)

Maybe Senator Vitter should introduce legislation promoting the sales of turtles to Canada. After all, one good turn deserves another.  Read More & Comment...

The Vitterization of Lord Nelson

10/04/2006 07:32 AM |

The Wall Street Journal reports that “Under pressure from Congress, U.S. Customs and Border Protection officials scrapped their 11-month-old policy of seizing prescription drugs imported through the mail from Canada.”

When politics trumps public health (not to mention outright security issues) we are heading down a slippery slope. Attention must be paid.

And shame on Senator Bill Nelson (D, FL) – a member (can you believe this!) of the Senate Committee on Homeland Security and Government Affairs – who was “investigating” the new Customs policy.

"This is a huge victory," Mr. Nelson said. "For nearly a year, the White House has been punishing seniors for filling their prescriptions at lower Canadian prices. Now it looks like the government is getting out of the business of harassing these consumers."

It’s a victory all right. A victory for profiteers masquerading as pharmacists. A victory for terrorists and smugglers who now have a brightly lit path for their nefarious schemes. And a victory for prescription drug counterfeiters who now need only a Canadian address to infiltrate the medicine chests of America.

Dan McLaughlin, a spokesman for Mr. Nelson, said the senator believes the seizures were politically motivated to bolster enrollments in Medicare Part D.

Note to Mr. McLaughlin -- didn’t the AARP say that American seniors get better deals on their medicines via Medicare Part D? (Answer – yes, they did.)  Read More & Comment...

"Effective" is like a box of chocolates

10/03/2006 01:48 PM |

... you never know what you're gonna get.

We here at drugwonks.com are all for “effective” from a patient-centric standpoint (“effective” meaning “most effective in treating a given patient). But we are highly dubious of people hijacking the word to mean “cost effective” (like in “evidence-based medicine” aka “health technology assessment” aka “rational use of medicine.)

It is, therefore, with pleasure that we pass along the following report from today’s edition of Drug Industry Daily(http://www.fdanews.com/did/5_192/cms/60829-1.html)

The future of the Centers for Medicare & Medicaid Services' (CMS) plan to share prescription drug plan data with the FDA in an effort to base Medicare reimbursement on product comparisons is in doubt as the agency determines whether it has the legal authority to share this information, an industry source says.

The CMS has been working with the FDA to develop this new program as a means to ensure the most effective products are covered by Medicare's Part D plan. While CMS Administrator Mark McClellan, the program's primary advocate, is leaving in October, that is not the reason why the program is in trouble, the source said.

The CMS is worried that, while the law gives it the authority to use Part D data for payment purposes, it may not be able to use this information to make comparisons between competing drugs. The CMS is also unsure whether it is able to provide the FDA this data for postmarket surveillance, as it originally planned.  Read More & Comment...

The Clinton-Schumer Biotechnology Elimination Act of 2006

10/03/2006 10:24 AM |

or the Gift to the Generic Drug Industry Act...whatever you want to call it...but here's the coup de grace according to an article about the so called Access To Lifesaving Medicines Act in Scrip Magazine:

"The legislation would authorise the FDA to approve abbreviated applications for biologicals that are "comparable" to the reference products approved under the Public Health Service Act.

Comparability means no clinically meaningful differences in safety, purity and potency, based on non-clinical studies and clinical studies as necessary. An applicant also must demonstrate that the comparable product shares the "principal molecular structure features" of the reference product and the same mechanism of action, if known. "

In otherwords, generic firms would have a separate and short track for developing biotech products based on the same mechanism of action without having to go through all the time and expense that a biotech firm has to go through. Which means all you have to do if you are a generic company is a little reverse engineering and try to punch a couple holes in a patent or two of a biotech product and claim you can whip up the same product with the same molecuar structure features --whatever the hell that means.

The bill assumes that biologics are therapeutically interchangeable or can be made so. Actually, the bill deals with this problem by simply avoiding the issue altogether by assuming -- incorrectly -- that the same mechanisms of action equals no clinical meaningful difference or should be the foundation for approval.

The bill gives the generic firms tax breaks and market monopolies as incentives to attack the patents of biotech companies (what else is this aggressive effort to promote interchangeability at any time during the patent period) and ban the ability of biotechs to produce their own biogeneric products even though that might be a safer and more effective product or in fact their might be scientific question as to interchangeability.

This Clinton Schumer bill is a car bomb driven up to door of biotech innovation that will explode years from now. It will lead to massive litigation and game playing. Rather than worrying about the price of biotech products, policymakers should encourage the promotion of personalized and targeted medicine and nanontech delivery systems that will lead to more appropriate dosing for the right patients at the right time.  Read More & Comment...

Once more into the breach … Granny

10/03/2006 09:15 AM |

Yes folks, it’s that time again.

November 15 begins the six-week enrollment season for Part D. The good news is that, in most states, beneficiaries will have 50 to 60 offerings to choose from, at least 10 more than in 2006.

According to an article in today’s edition of The Wall Street Journal, “Who should consider switching? Prime candidates are those who picked plans for this year that provided coverage of the so-called doughnut hole, or who fell into that gap and now want coverage for it. For a higher premium, some plans offer to cover drug expenses through the gap.”

We'll see if smart providers start promoting this alternative.

Also according to the WSJ, “In another shift, many plans are making changes that will reduce the chances that consumers will even reach the $2,400 level where the coverage gap starts. By eliminating co-pays for generic drugs in some plans, for instance, insurers are making such treatments essentially free to patients (at least until they reach the coverage gap). Aetna is dropping co-pays for generics in many of its plans, while Cigna says it is eliminating generic co-pays in all of its most basic drug plans.”

How do we do it? Volume!

Further, the WSJ keys into the fact that, properly leveraged, market forces are increasing both choice and quality. “There may be a huge market of potential shoppers. Only 20% of 3,400 beneficiaries surveyed last month by J.D. Power & Associates said they would definitely stay with the plan they had. About two million Americans will turn 65 in 2007 and also will be eligible. At least another four million, including three million low-income beneficiaries not subject to penalties for missing the deadline earlier this year, have yet to enroll.”

Somewhere Mark McClellan is smiling.  Read More & Comment...

Berenson's Missed Taxol Tackle

10/03/2006 12:45 AM |

NYT Alex Berenson's recent article " Hope, at $4,200 a Dose" is a bit on the sloppy side when it comes to the facts.

He complains about the price of ABRAXANE which he correctly but not completely describes as "a reformulated version of paclitaxel, a chemical found in the Pacific yew tree that destroys cancer cells. "

To assert that the two products "have similar side effects" is incorrect. He could have looked (and he did) at a Sept 7 FDA Oncological Products Advisory Committee meeting transcript or the data from the clinical trial....both of which had the following language more or less ... Neutropenia on this study was greater for Taxol than it was for Abraxane even though 50 percent more paclitaxel was being administered to the Abraxane patients. This was highly statistically significant and was true whether you looked at all-grade toxicity or just focused on
Grade 4. "

Berenson makes a big deal of how the company that makes Abraxane -- Abraxis -- tried to get the FDA to approve the use of its drug for early stage breast cancer (just like Taxol) by claiming that Abraxane is just Taxol without the toxicities and can be administered more quickly at higher doses. The FDA did not buy that argument since the pharmacokinetics of the two products are completely different and approval of Abraxis in the metastatic setting required a small randomized controlled trial.

In any event, Berenson was trying to use Abraxis' words against them to underscore that generic Taxol costs $150 compared to Abraxane which $4200. And only Bravve Alex is willing to raise the tough question of whether it is worth it to pay $4200 for a drug that is really no different and doesn't increase survival -- the latter measure now being the new gold standard for reporters who want to trash cancer drugs -- all of them it should be noted do not have late stage cancer and it seems are single and don't have kids and spouses to worry about.

Setting aside the fact that it was the New York Times that helped lead the charge about how BMS was gouging the public when Taxol was going for $8000 a treatment cycle, especially because it got the drug at a preclinical stage through a partnership with NIH, the idea the only good cancer drug is a cheap one that adds ten years of life (median) when someone has the advanced form of the disease reflects callousness, misunderstanding or a political agenda or all three.

And to suggest that some public policy could step in to ratchet down prices for unique drugs (Berenson uses the voice of a 'patient' from the National Breast Cancer Coalition on this score) raises the question as to what that mechanism might be. We have seen what "works" in Cananda, the UK, Australia and the VA....just limiting who gets the drug based on some arbitrary criteria that has nothing to do with genomics, compassion or pain. And for Berenson's elightenment, here is what British oncologists had to say about the five years it took for the UK's rationing agency to finally approve of the use of Taxol in a metastatic setting:

"Some health authorities, despite the authoritative advice of leading cancer specialists, have held off from making full use of this licensed medicine . . . . It is regrettable that lives will have been lost while a medicine, which had already proven its clinical value, has had to pass through what is effectively a further approval system before being widely prescribed in the UK."

Now they are doing the same thing with Herceptin, Gleevec, etc.... using the same excuses put forth by Berenson and others. Maybe Carolina Hinestrosa of the National Breast Cancer Coalition would be interested in making the judgement about prices and rationing since she is so keen in finding a public policy mechanism....  Read More & Comment...

Good Editorial in the Washington Times on Drug Safety

10/02/2006 11:56 PM |

Dangerous Disconnent on Drug Safety
Sept 30, 2006

This week, scientists completed mapping the mouse brain down to details of individual cells. Because much of the neurochemistry of humans mirrors many of the pathways found in mice and rats, researchers will be able to use this molecular guide to more quickly determine which medicines might work to control or delay the progression of such devastating brain illnesses as Alzheimer's, Parkinson's and Lou Gehrig's disease.
But first some enterprising researcher should use the map to explain the disconnect in the minds of some between the crushing burden such diseases impose on families and society and proposals that that supposedly benefit the public health but in fact delay the development of new medicines. They can also make them more difficult and more expensive to introduce.
One subject of this study should be the Institute of Medicine (IOM), which just released a report on the Food and Drug Administration's ability to monitor the safety of medicines. The study asserts that it is impossible to make a medicine 100 percent safe and harder still to understand (using methods the IOM admits are inaccurate and outdated) why some people react badly and some respond well. Rather than recommending a more computerized and gene-based approach to detecting and predicting safety problems -- which can affect a very small group of patients -- the IOM wants the FDA and companies to spend billions conducting randomized clinical trials that test everybody as if they were the same to discover what current methods rarely find in the first place.
Will this make medicines more expensive to make? IOM is indifferent. Will patients doing great on a drug enroll in a safety study where they have half a chance of not getting the medicine keeping them alive? It never crossed the minds of the IOM solons.
The other subject should be Sen. David Vitter of Louisiana, who sees no connection between barring Customs Agents from inspecting packages of medicines from Canada and the prospect of polluting the entire prescription-drug supply of the United States. Individuals carry much of the illegal narcotics coming into this America under threat of arrest. Thanks to Mr. Vitter's amendment to a Homeland Security bill, counterfeiters and suppliers of controlled narcotics will be able to cross from Canada into America.
A flood of bogus drugs for diseases such as Alzheimer's, heart disease and cancer won't be discovered until they enter the market. By that time it will be too late and too expensive to track the problem. The same can be said for IOM's after-the-fact and outdated approach to drug safety. Both will lead to fewer innovations.  Read More & Comment...

Will Brussels DTC the Light?

10/02/2006 08:51 AM |

According to a recent Populus survey, when asked what reforms would most likely increase their quality of care, people in eight old and new EU member countries responded by a large margin, “giving patients more information about their illness."

And Brussels may indeed be moving in that direction.

Last March in Brussels I appeared on a panel with James Copping, the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations on a how the EU should address what they refer to as ItP or Information-to-Patients.

One interchange between Jim and me that is worth sharing:

COPPING: "We must find new ways to regulate health care information to patients."

PITTS: "Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: "Yes, that’s right.”

Well, it seems as though Mr. Copping has done just that.

According to a report in the The Financial Times, draft recommendations prepared for a pharmaceuticals forum, jointly chaired by the European commissioners for enterprise and health, will call for industry participation in partnerships for "information creation and exchange" on diseases for patients and citizens.

They propose a trial scheme to provide "high-quality health-related information" on diabetes, offering data to the non-specialist in all official EU languages, drawing on authorised disease databases, with input from doctors, patient groups and health insurers as well as industry.

The move would mark a significant shift away from the current ban in Europe of US-style "direct to consumer advertising," which forbids drugs companies from any form of direct communication with patients.

With partial exceptions in the UK and Sweden, European legislation prevents drugs companies from even responding to inquiries from patients, let alone advertising their medicines beyond specialist publications for medical professionals. That has created a situation long decried by the industry, by which patients can find all manner of unreliable information on diseases and treatments on the internet, with the pharmaceuticals manufacturers the only groups banned from providing data.

The initiative comes after previous efforts to ease the rules on pharmaceuticals communication were crushed by health insurers and consumer groups wary of industry influence and manipulation.


Good luck Mr. Copping. We're watching.   Read More & Comment...

Jack's ... or better

10/02/2006 07:19 AM |

If you’re looking for a superb discussion of the unintended consequences of choice controls (aka “price controls”) look no further than the excellent new paper by John Calfee and Elizabeth Depre of the American Enterprise Institute.

Here’s a hot link:

http://www.aei.org/publications/pubID.24889,filter.all/pub_detail.asp

Along with a few thoughts to ponder ...

* As we proceed further down the path of personalized medicine via both targeted therapies and gene testing, those nations (mostly in the EU, but also Canada, Australia and -- to a lesser degree -- Japan) that impose price controls via the threat of compulsory licensing will find that what once was a Thor's hammer has become a toy hammer. More and more pharmaceutical firms will just say no to such blackmail and increasing numbers of patients in these otherwise developed nations will have neither access to nor, for that matter, knowledge (because of the EU's neroses about direct-to-patient information) about cutting-edge treatments.

* As a result, therefore, the overall global prices for these new therapies will go up -- while they go down in the US. Why? Because, minus price controls for these cutting edge therapies, the rest of the world will be forced to carry their fair share of the R&D costs now being carried almost exclusively on the backs of the American health care consumer.

* But you can't get blood from a stone. If EU nations continue to abide by absurd health technology assessment protocols they will simply say there is not sufficient "evidence" to showi that these new, more targeted (and, therefore, safer) therapies are of sufficient "added benefit."

Result? More American health care holidays for those Europeans who can afford it. And for those who cannot -- zero access to 21st century medicine.

Denial is more than just a river in Brussels.  Read More & Comment...

Trasylol

10/01/2006 04:40 PM |

Totally unacceptable. Just totally unacceptable.

Shameful.

But, sorry Senator Grassley, it does not "prove" that the FDA is "toothless."

In fact, it shows just the opposite.  Read More & Comment...

Grassley's Exempts Himself From Being Consistent on Federal Regulation

10/01/2006 01:40 PM |

Grassley, EPA clash on dust limit


Whenever the FDA doesn't do exactly what Senator Charles Grassley thinks is right or issues a ruling on a drug he disagrees with that seems to favor a drug company, he is quick to claim it is another example of how the FDA is sacrificing public health because it has a "cozy" relationship with industry.

So I guess that means when the EPA does not make a special exception to a particular industry in enforcing a public health-type rule and a Senator tries to carve out an exemption, that relationship would be defined as....how? I am sure the EPA has some very good scientific data to support it's position. So I am sure Senator Grassley was not criticizing the integrity or intelligence of EPA scientists when he called the ruling "idiotic" because he has made preserving the intellectual independence of people like David Graham a keystone of his career in the Senate. He would never try to bully or cajole an agency into changing it's stance...that wouuld be inconsistent and political and undermine his morally insufferable position on FDA issues and drug safety...


DES MOINES, Iowa Senator Charles Grassley is clashing with the Environmental Protection Agency.

The dispute comes after the agency reversed its course on exempting agriculture operations from dust regulations.
The Bush Administration says it decided against the exemption because officials could not legally exempt specific industries.
Grassley, a Republican, disagrees with the opinion. He says it is -- quote -- "such an idiotic move for the EPA to take" -- end quote.
The senator has sent a letter to the E-P-A's top administrator inviting him to visit Grassley's farm in Iowa.
He has asked for a response within 24 hours.  Read More & Comment...

Kevin Freking's Part D Denial Disorder

09/30/2006 07:32 PM |

Is is my imagination or is the AP Kevin Freking the only journalist in America who refuses to accept that Medicare Part D is a resounding success. See his most recent article entitle Seniors to Get More Medicare Drug Choices. Freking stands alone -- actually with the only person in Washington who can't say anything good about the Part D benefit, Families USA Godfather Ron Pollack -- in asserting that the rollout of more Medicare Part D plans with lower premiums, fewer restrictions, more drug choices and better tools for managing costs is a terrible thing because it's confusing:

"Seniors who complained this year about a dizzying array of choices for a Medicare drug plan may find themselves even dizzier when they shop around for next year.

Federal officials announced Friday that 17 companies have been approved to provide Medicare drug coverage nationally. This year, there were nine."

Actually, since 90 percent of all seniors signed up for the program and a small percentage who hit the donut hole really had a problem after doing so, Freking had to scrape around for a quote from -- who else -- the Don of Part D Doom himself, Ron Pollack to underscore just how crappy the program really is:

"The incredible confusion that persisted throughout this year is about to get considerably worse," said Ron Pollack, executive director of Families USA, an advocacy group. "This is because there will be quite a few more plans to choose from, they will all be different from each other, and seniors will have a much shorter time period to make decisions about enrollment."



Similarly, Freking reaches down to another well paid malcontent, Deanne Beebe," a spokeswoman for the Medicare Rights Center, said that seniors won't be won over by all the additional options.

"They don't want dozens of choices," she said. "They want one affordable drug benefit they can count on when it comes time to fill their prescription."

Yes, Ron annd Deanne compared to the one size fits all system where seniors would wait five years to get many of the newest medicines while the government negotiates prices and restricts access there will be quite a few more plans to choose from. As for seniors not wanting dozens of choices, I propose that Beebe rollout a the VA style approach and try to sell it with the longer waits for drug approvals, fewer drug choices and in some cases, higher out of pocket costs..

The triumph of ideology over compassion and common sense.  Read More & Comment...

Patients lack key Rx information

09/30/2006 01:55 PM |

This is news?

Well, since it's true it's worth repeating, and since it's based on "a new study" it's worth reporting on. Still, I'm surpised that it even made the UPI wire. So much the better.

Here goes ...

"Patients who leave the doctor's office with a prescription may be leaving something important behind."

Car keys? No, they're leaving, brace yourself, without "the information they need to take their medicines correctly."

In fact, according a new study (see, told you) from UCLA (go Bruins!) doctors only give their patients 62% of five "key pieces" of information:

* Patients were told the name of a new medication only 74% of the time.

* Patients were told why they were taking a new medication only 87% of the time.

* Only 30% of patients were told how long to take the new prescription.

* Only 55% of patients were told how many tablets to take.

* Only 58% for both frequency and appropriate timing (with food, etc.)

And the winner is:

* Doctors told patients about potential adverse events of a new medication only 35% of the time.

To be fair this was a study based on data collected from 185 outpatient visits to 44 physicians, so draw your own "margin of error" conclusions.

(I wonder how are they going to pin this one on the pharmaceutical industry?)  Read More & Comment...

Thar she Breaux's

09/29/2006 01:46 PM |

Ceasefire Event with David Kendall and Peter Pitts

I'm very excited to participate in the October 11th Ceasefire on Healthcare debate with David Kendall who served on President Clinton's Task Force for Health Care Reform. As you probably know, the forum (led by former Senator John Breaux) seeks to find “common ground” for meaningful, bipartisan change to the nation’s health care system.

I hope you can attend or tune in for the podcast. Here are the details:

Professor James A. Thurber, Director, American University’s Center for Congressional and Presidential Studies, invites you to join him and former Senator John Breaux at a Lunch Forum on Health Care Reform, featuring David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute, and Peter Pitts, Director of the Center for Medicine in the Public Interest (CMPI).

October 11, 2006

12:00pm - 1:30pm
Butler Boardroom, American University

Speakers:

David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute

Peter Pitts, Director, Center for Medicine in the Public Interest (CMPI)

For more information about the Ceasefire on Healthcare Series, please visit www.ceasefireonhealthcare.org.

Please RSVP to the center (ccps@american.edu) by October 6, 2006.

Contact Melissa Castle, (202) 885-3491, mcastle@american.edu, for more information.  Read More & Comment...

FDA: Neither Too Fast Nor Too Slow, Just Underappreciated

09/29/2006 11:30 AM |

In one week the FDA has been pilloried as being to ineffectual in the effort to make medicines safer and now, in a New York Times article, described as an agency under seige too afraid to approve any new medication in a timely fashion. Has anyone ever written an article commending FDA employees for just doing a good job on behalf of the public health?

The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.

The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.

The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.

Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.

On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...

Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.

Highlights for 2005 include:

* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).

* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).

* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).

* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.

* 10 “orphan” medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.

* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.

* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.  Read More & Comment...

This You Call Evidence?

09/29/2006 10:04 AM |

Scott Hensley's article in today's WSJ underscores both the hypocrisy and inherent limitations of so-called evidence based medicine. J&J is hoping to launch a form of risperidal called paliperidone that is described only as being released over a 24-hour period of time and is therefore more tolerable to the liver in some people. One potentially important point Hensley left out of the story is that the form of risperidal JJ seeks to market is known to have a lower concentration of transmembrane transporter P-glycoprotein (P-gp) P-gp potentially limits access to brain tissue of psychoactive substrate which means that the lower concentration could make it more valuable to patients who don't respond well to Risperdal because of they way they metabolize the products. In other words, paliperidone could be a medicine for a small but clinically underserved group of schizophrenics. But JJ is going to have to do to the heaving lifting to demonstrate that is the case.

Meanwhile, Hensley cites the example of the HMO that simply decided it would stop paying for Medium because they are cheaper versions that are as effective. Where are the media skeptics demanding the source of the data for this decision? Isn't this a conflict of interest? What about the fact that the Roche Amplichip allows MDs to distinguish how well patients metabolize difference proton pump drugs? What if you can't handle Prevacid or Protonix? My daughter couldn't take either and she had to be prescribed Nexium. Why should she or anyone else be forced to pay out of pocket because she genetically unable to metabolize other PPIs? Isn't this a form of genetic discrimination?

So much for evidence based medicine. It's evidence when the HMO decides to dump a drug, but conflicted propaganda to promote a me-too drug when a drug company decides to bring a new medicine to market?  Read More & Comment...

Is Europe Beating US to the Critical Path?

09/29/2006 09:39 AM |

Disturbing news that the EU may be eating our continental breakfast in the effort to make drug development more effective and efficient. Innomed, the European Platform on Innovative Medicines, is looking to hammer out a deal in which pharma companies and the EU kick in about $750 million a year over ten years towards process improvements in drug development and regulatory reforms. Meanwhile, back home we squabble about spending more to collect an increasing amount of paper about post market safety, shutting down PDUFA and imposing criminal penalities on companies that refuse to complete post market studies that most patients don't want to enroll in. At the same time, FDA has a grand total of 6 million for Critical path and its overall budget is cut in the House.

Note to all those who posture on stem cell funding. It won't do a damn bit of good if we have a 19th century drug development infrastructure for testing products based on such research.  Read More & Comment...

Where Pro Choice Meets Pro Life

09/29/2006 07:00 AM |

Hurrah for a David Leonhardt and his superb article “The Choice: A Longer Life or More Stuff” (New York Times, September 27, 2006).

It’s a very thoughtful and provocative essay about what we, as a society, receive for what many pundit, pols, and MSM savants derisively refer to as “spiraling health care costs.”

Mr. Leonhardt writes, “Living in a society that spends a lot of money on health care creates real problems, but it also has something in common with getting old. It’s better than the alternative.”

As David Cutler (our second favorite health economist) points out in “Your Money or Your Life,” in 1950 the average American spent less than $100 a year ($500 in today’s dollars) on medical care. That number today is $6000.

And, according to Leonhardt, “Most families in the 1950’s paid their bills, but they also didn’t expect much in return. After a century of basic health improvements like indoor plumbing and penicillin, many experts thought that human beings were approaching the limits of longevity.”

Remember what biologist Rene Dubos wrote in the 1960’s, “Modern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases.”

As Walter Wriston famously quipped, “The future isn’t what it used to be.” He was wrong. And so was Monsieur Dubos.

Dan Quayle was more on the mark (kind of) when he said, “The future will be better tomorrow.”
That's turned out to be surprisingly prescient.

Mr. Leonhardt points out that perhaps “spiraling” costs are, well, worth it. “A baby born in the United States this year will live to age 78 on average, a decade longer than the average baby born in 1950 … If you think about this as the return on the investment on medicine, the payoff has been fabulous: Would you prefer spending an extra $5500 on health care every year – or losing ten years of your lifespan?”

And what do you think the proponents of so-called "rational use of medicine" would have to say about that? Ultimately, they say what Leonhardt points out as both true and frightening -- "that the best way to reduce health care spending is to reduce health care itself."

That is not acceptable in our affluent society. In First World societies health care is precisely how we should spend our money. As David Cutler writes, “We have enough of the basics in life. What we really want are the time and the quality of life to enjoy them.”

And to do this we must be able to choose the health care (yes – even the pharmaceuticals) that are best suited to our individual needs. Choosing to support spending on health care means choosing life.

Health care: it's where pro-choice meets pro-life.  Read More & Comment...