NEJM Adds Nothing to the Drug Safety Discussion

10/09/2006 05:20 PM |

NEJM is running with two editorials on the heels of the IOM report on FDA's drug safety performance. One editorial is written by IOM task force member Bruce Psaty who has a history of dredging up data designed to scare without regard to accuracy. As one observer put it: Another breast cancer-scare story came during NBCAM at the expense of a widely prescribed class of drugs used to treat high blood pressure, called "calcium channel blockers" or CCBs. Published in the journal Cancer, this study reported post-menopausal women using CCBs had a 150 percent increased risk of breast cancer.

But the study was small and, as stated in a National Institutes of Health press release, "the findings do not establish a causal link between calcium channel blocker use and breast cancer." Moreover, the study conflicts with results of SYST-EUR, a recent long-term clinical trial of CCBs that did not reveal any increased cancer incidence.

The Cancer study is just the latest in a series of CCB-scares manufactured by Dr. Curt Furberg of Bowman Gray Medical School and oft-time cohort Dr. Bruce Psaty of the University of Washington. Their first scare linked CCBs with increased heart attack risk. But the evidence was so shoddy that Dr. Psaty was forced to apologize to colleagues at the American Society of Hypertension for launching a scare based on a single study with serious limitations.

Psaty is the lead author of the editorial in the NEJM calling for more clinical trials after market and a ban on DTC.

In any event, as I have said before, the IOM missed an opportunity to build support for effort to support more funding for programs that could truly make medicines safer without burdening drug development with pointless studies that will only make the process more costly and limit access to new medicines without regard to more precise risk/benefit profiles. As the FDA's Critical Path report noted nearly 4 years ago:

"Safety issues should be detected as early as possible, ways to distinguish potential from actual safety problems should be available..." Neither the IOM and NEJM talk about the use of biomarkers and the development of observational databases that could be mined to develop predictive models, the creation of more targeted medicines, the use of genetic tests, investment in data consortium. No. Just bigger, government funded studies that take years to organize, conduct and sort out. And meanwhile, patients and doctors are supposed to labor under onerous risk management programs that dole out drugs under the scrunity of government appointed risk finders who limit the expanded use of medicines.

Is there anyone in the media who will challenge or examine this conventional wisdom?  Read More & Comment...

Doug Badger To Blog and Join CMPI

10/09/2006 02:43 PM |

Our friend, colleague and thought leader in the health care field, Doug Badger is now in the private sector. We crossed the partisan divide (Doug is a Phillies fan and Peter and I are STILL Yankees fans despite the meltdown of the past week) to ask Doug to join us. We are glad he did. And so will those of you who follow this site and our work. Here's the release announcing his appointment as a senior fellow:


Doug Badger, a partner at the Nickles Group and former deputy assistant to President George W. Bush for legislative affairs is joining the Center for Medicine in the Public Interest as a Senior Fellow. Doug will conduct research and write on consumer-driven health care, Medicare reform and the impact of medical innovation on health care financing. He will also be a regular contributor to CMPI's popular blog, drugwonks.com.

CMPI co-founders Peter Pitts and Bob Goldberg said: "Having Doug Badger join an emerging think tank like CMPI is like having Derek Jeter sign with a new baseball franchise. He is one of the most creative and knowledgeable health care experts in America. We look forward to sharing Doug's energy, humor and optimism with the broader public."

Doug joined the Nickles Group in September 2006, after serving as a senior White House adviser. As deputy assistant to the President for legislative affairs, Doug helped formulate Administration policy and legislative strategy on a broad range of issues, including health care, energy, taxes, financial services, pensions and employee benefits, intellectual property, trade, and telecommunications.

Badger also served for two years as the President's lead health policy adviser, developing the Administration's proposal for adding prescription drug coverage to Medicare and representing the White House in negotiations with Congress that resulted in enactment of the Medicare Modernization Act. He also advised the President on other health-related matters, including Medicare and Medicaid reimbursement issues and the creation of health savings accounts.

Prior to joining the White House, Badger was a partner at Washington Counsel Ernst & Young, where his practice included health care, intellectual property, and employee benefits.

He also served for a decade as a U.S. Senate aide, including stints as chief of staff to Assistant Majority Leader Don Nickles and staff director of the Senate Republican Policy Committee. Badger also has held senior positions at the U.S. Department of Health and Human Services and the Social Security Administration.  Read More & Comment...

North Korea, Drug Counterfeiting and Senator Vitter

10/09/2006 09:23 AM |

Congressional Research Service reports that North Korea is producing counterfeit pharmaceuticals to finance its military-industrial complex.

Canada of course is a prime transhipment spot for counterfeiters in an indictment that was unsealed by a Joint Federal Task Force on drug counterfeiter that is going after a ring involving...North Korea of course.

Thank you Senator Vitter for standing tall on the issue of drug importation.  Read More & Comment...

Bouquets & Brickbats Brussels Style

10/09/2006 07:00 AM |

All is not quiet on the Western Front.

Since the EU’s High Level Pharmaceutical Forum (HLPF) recommended that Europe revisit new, more patient-friendly rules towards direct-to-consumer health care information (what our transatlantic cousins refer to as, “information-to-patients” or “ItP”) the merde has hit the fan.

Hey, you gotta break some eggs to make an omelet.

Bouquets to MEP Jorgo Chatzimarkakis, one of the EU Parliament's three representatives on the HLPF, who finds the current information ban on medicines unacceptable. "I can understand a ban on advertisements but I can not agree on the ban on information, which leads us to a situation where patients are obliged to surf around the Internet to look for information on medicines. Citizens can not be deprived of information by their own governments on such crucial issues as one's health," he argues.

And brickbats to Health Action International (HAI) who claims, “there is no health information gap in Europe.” (www.haiweb.org). HAI (no relation to Hospital Acquired Infections – but you think they would have thought about that before adopting the acronym) disallows with a wave of their hand any useful participation by the pharmaceutical industry in providing patient information because of a “natural conflict of interest.” How very Rousseau. But concepts of natural liberty notwithstanding, HAI offers up al lot of the usual anti-industry accusations without even a scintilla of evidence. I guess since it’s “natural,” no proof is required. Weak argument.

And who does HAI consider excellent sources of patient information? Get this – IQWIG and NICE to name two. Really. I am not making this up.

HAI waves the usual banners of “evidence-based medicine,” “rational use of medicine,” and the “over-medicalisation of the European population.” And they are very clearly adherents to the Precautionary Principle of "doing nothing until you know everything" (not surprising since one of their major funders is the Rockefeller Foundation).

And listen to this, “For each option (of type of medicine) patients should be able to clearly identify benefits (degrees of clinical effectiveness on important outcomes, convenience, etc.) and harms (potential side effects, disturbances of personal and social life, etc.). Yes – and every taxpayer should have a deep and profound understanding of the tax code. How about this as a recommendation – let patients have access to information from every source and then let them speak with their physicians. That’s when good things happen.

“Degrees of clinical effectiveness?” Isn’t that the job of … physicians?

By the way, in case you’re wondering about where HAI gets its money -- out of a total budget of €1.022.169 (2002 figures are the latest available) €557.604 came from the Dutch Ministry of Foreign Affairs. Of that funding, €300.104 was spent on something called the “Drug Pricing Project.”

Aha and indeed. Will better-informed consumers want broader access to more pharmaceutical options? Nuff said. And let's face it; EU governments don’t want to spend the money -- outcomes notwithstanding. No wonder HAI points to IQWIG and ilk as the best sources for consumer health care information.

What a blatant charade.

Information is Power.  Read More & Comment...

A new treatment for a rare lymphoma: Circle of Cancer Cynics Ready to Pounce

10/06/2006 05:08 PM |

The FDA approved Zolinza for treating of advanced forms of cutaneous T-cell lymphoma (CTCL). Zolinza is the first in a new class of cancer drugs to win FDA approval. The drugs, called histone deacetylase inhibitors, are thought to silence some genes that, when left unchecked, allow cancerous cells to proliferate.

"We see CTCL as the tip of the iceberg," said Dr. Stanley Frankel, senior director of clinical research in oncology for Merck. (Which licensed the drug from a biotech firm) "It proves that this pathway can be attacked effectively and therefore make for an entirely new way of treating cancers."

While some early trial results seem promising, Zolinza's effect on the larger cancer question remains to be seen, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer. The pathway targeted by the drug is a relative newcomer in the cancer field, he added.

"There is a lot of excitement about targeted therapies. This is not the same type of mechanism as those other agents; nonetheless, any new approach to treating cancer — any novel approach that uses a new pathway, that can be taken by mouth, has limited side effects — merits more attention and hopefully will be successful over time," Lichtenfeld said.

Well that's what you think.

I can't wait for the next spate of articles from those reporters and pundits who I have named the Circle of Cancer Cynics. Their motto: if the drug doesn't increase survival by more than a month or so...who needs it? Founding member: Merrill Goozner who sees Avastin as a useless drug since it does not prolong median survival in cancer patients who have failed other treatments and are about to die. Platinum members include every reporter who has written or rewritten the "so much money and the portions are so small" story about cancer drugs into the ground. Gold members include the handful of doctors who get paid to say these sort of things in Europe and Canada to justify rationing


Using this new litmus test, Zolinza should be scrapped in favor of surgery, painful radiation and chemotherapy or just plain dying and stop wasting all the money that could be spent on universal health care for all. According to a report on the drug given at ASCO, the overall response rate for vorinostat was 29.5%. Time to progression was 148 days for all patients and greater than 203 days for responders.

Less than two lousy months of delayed tumor progression AND NO survival benefit?
Why if Goozner and co had their way, the government would set the research agenda consistent with other social goals -- like universal healthcare -- and have had the FDA reject the drug on the basis of some 5 year multi-center comparative effectiveness study developed, designed and administrered by the government. Every drug would have to pass through that hoop instead of going directly to doctors and patients.

Problem is, taking a look backward we see that survival rates have risen and mortality as a function of diagnosed cancer has declined because of the timely access to these 'useless' drugs. And their value to patients and their families -- in terms of more productive time together -- is in the hundreds of billions.

But if you are part of the Circle of Cancer Cynics, there is no accounting for value or quality of life over time or ever. Either a drug cures you or you should stick with what is now around.

I'd like to see them tell that to parents with kids dying of cancer. They don't have the guts.  Read More & Comment...

So you think developing a drug is easy?

10/06/2006 04:56 PM |

Here's Decode Genetics, a pioneer in the field of personalized medicine, foundering on the rocks of manufacturing...Seems as though if the drug doesn't dissolve at a certain rate, it won't work. The good news is that Decode was able -- before bringing the drug into later trials -- to pinpoint the problem because of the link between genetics and metabolism. It's an excellent example of why more money and time -- not less -- should be spent on the Critical Path to address drug safety issues.

deCode halts trial of heart attack drug
NEW YORK (AFX) - Biotech drug developer deCode Genetics Inc. said Friday it suspended a late-stage clinical trial for a heart attack prevention drug because of a manufacturing issue with tablets supplied for the study.
The company stopped the trial when it found tablets of the drug veliflapon appeared to be dissolving too slowly, which it said would interfere with gauging the drug's effectiveness.

Reykjavik, Iceland-based deCode said it had presented the problem to the U.S. Food and Drug Administration and is exploring alternative manufacturing processes for the drug.
The company may be best known for licensing the genetic information of Iceland's population.
Using the population data, Veliflapon is one of two compounds the company has linked to two genes that encode proteins that could raise the risk of a heart attack. The other compound is in early stage clinical trials.  Read More & Comment...

Nobel Intentions

10/06/2006 03:27 PM |

Imagine if we decided that there was a “crisis” in American transportation – that transportation was “too expensive.” Would we opt to slash spending for new road and bridge construction?

Now imagine there is a crisis in American health care.

Tyler Cowen (professor of economics at George Mason University), in a very thought-provoking article in the New York Times, makes some important points vis-à-vis investment in pharmaceutical development and a reality check on outcomes both in the US and abroad.

A few enticing cantlets:

“The American government could use its size, or use the law, to bargain down health care prices, as many European governments have done. In the short run, this would save money but in the longer run it would cost lives.”

“Medical innovations improve health and life expectancy in all wealthy countries, not just in the United States. That is one reason American citizens do not live longer.”

“The National Institutes of Health’s current annual research budget is $28 billion, All European Union governments, in contrast, spent $3.7 billion in 2000, and since that time, Europe has not narrowed the research and development gap.”

“In the last 10 years, for instance, 12 Nobel Prizes in medicine have gone to American-born scientists working in the United States, 3 have gone to foreign-born scientists working in the United States, and just 7 have gone to researchers outside the country.”

“Even when the initial research is done overseas, the American system leads in converting new ideas into workable commercial technologies.”

“The gains from medical innovations are high. For instance, increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. And that is just for the United States.”

Here is a link to the original article:

http://www.nytimes.com/2006/10/05/business/05scene.html?_r=1&oref=slogin  Read More & Comment...

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...