Latest Drugwonks' Blog

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

We here at 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(

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.
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.
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.
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....
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.
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.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog