Latest Drugwonks' Blog

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.” (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.
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:

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

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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