Latest Drugwonks' Blog

You’ve got a friend in Pennsylvania? Not if you’re a low-income patient who needs access to the best medical treatment for your condition.

First Health/Provider Synergies, the PBM used by the Quaker State to manage most of its Medicaid formulary decisions, has adopted a draconian new procedure that will make it almost impossible for Medicaid-eligible Pennsylvanians to get any new, cutting-edge medicines.

Astonishingly, FH/PS will give each pharmaceutical innovator one hour per year to make clinical presentations on all their products and one additional hour per year for "continuing education" on their products. This is not one hour per product; this is one hour per company!

This is a staggering demonstration of disinterest in clinical information, further demonstrating Medicaid’s broken process for choosing medicines -- more akin to a rug bazaar than proper science.

And it negatively impacts Pennsylvania’s neediest population. In a private plan, the consumer can make a choice to accept a higher co-pay for the medicines their doctor deem best for their condition. Medicaid recipients cannot. Typically, a prior authorization enforced by FH/PS makes it impossible for Medicaid recipients to get the medicine their doctors want them to have.

When cost-savings are put ahead of patient health, it’s not only bad process, it’s bad medicine.
On the heels of Steve Usdin's great piece on the outdated approach FDA critics are takig to drug safety comes an excellent piece by the Newark Star-Ledger's Kitta MacPherson.
Pretty inteilligible quote by yours truly on the failure of second-guessers to call for more funding for Critical Path and to accelerate use of biomarkers and other approaches to identify safety signals before drugs are on the market and to "tag" people before they are prescribed. For Bruce Psarty to say -- "yes, pharmacogenomics is an exciting tool but not ready for prime time so let's spend billions on even larger clinical trials and reviewers and risk management programs" is to simply make it even more difficult to create better tools. And since the IOM report does claim that the most important recommendation it makes is to INTEGRATE safety and efficacy evaluation, why is everyone suggesting steps that separate them instead of supporting science-based techniques that achieve that goal.

Here's the link to the Star-Ledger article

And one more thing: Curt Furberg's article on drug safety in the Archives of Internal Medicine.... Here's Furberg explaining his reasoning for putting a "black box" or additional risk warning on drugs for ADHD:

"On the surface, it is hard to believe( so many children really have ADHD)," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."

In otherwords, Furberg decided to scare people away from using "these drugs" because he thinks most kids don't need them.... That follows the bogus cancer scare and Psaty ginned up regarding calcium channel blockers... And we are supposed to follow his lead on how to reform the FDA.
The precise and prosaic Steve Usdin, Washington, DC editor of BioCentury, offers a prescient and penetrating perlustration on the impact and implications of the recent IOM report, the pending Enzi/Kennedy legislation, and their potential repercussions on the forthcoming battle over PDUFA reauthorization.

Must reading.

Here's a link to the article entitled, "Total Lifecycle Regulation" ...

Download file
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?
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,

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.
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.
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.” ( 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.
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.
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.

Nobel Intentions

  • 10.06.2006
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:

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.

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