Latest Drugwonks' Blog

Respected cardiologist Michael Weber sets the record straight on the degree of "influence" the pharmaceutical industry has on how physicians practice medicine (DTC, detailing, etc.). And the record needs setting straight.

His video interview can be found here:

www.vimeo.com/1045899

(Other "newsmakers" interviews can be found at www.cmpi.org)

Dr. Weber, we are proud to say, serves as Chairman of the Board for the Center for Medicine in the Public Interest (the public policy home of www.drugwonks.com).

According to Bloomberg, two companies that produce different types of stem cells have signed contacts to sell their products to drugmakers, showing the new technology will be used to help discover medicines not just to repair or replace damaged cells.

California Stem Cells Inc., an Irvine, California, biotechnology company that turns embryonic stem cells into neurons, said today it's selling the brain cells to researchers trying to find drugs to treat Lou Gehrig's disease. CellDesign Inc., of New Haven, Connecticut, said it has contracts with four drugmakers seeking to use its product to find new medicines for conditions such as Parkinson's disease and schizophrenia.

The efforts of these two closely held companies indicate stem cells will aid in the search for old-fashioned drugs long before they're infused into patients. It also suggests that the first businesses to benefit from stem cell technology will be traditional pharmaceutical companies and their suppliers not developers of new kinds of therapies.

``It's similar to what happened in the last century with molecular biology'' and gene therapy, said John Hambor, CellDesign's founding chief executive officer, in a telephone interview yesterday. ``We're now going down a similar path with stem cell biology. While it may lead to cures by itself, it will drive the next generation of drug discovery.''

Here's a link to the complete story:

http://www.bloomberg.com/apps/news?pid=20601124&sid=aYKfThhsUVwI&refer=home

 Exciting stuff.

Cell Cultures

  • 05.27.2008

At a recent European Commission-sponsored high level conference, Internal Market Commissioner Charlie McCreevy, commented that the EC wants practical, pragmatic suggestions for fighting the “modern-day highway robbery” known as piracy and counterfeiting. McCreevy stressed that more regulation is not the answer, and that solutions lie with public-private cooperation.

Don’t get me wrong – I’m all for free-market solutions and public/private cooperation.  But when it comes to counterfeit prescription medicines (aka:  International Health Care Terrorism) national and international law enforcement agencies as well as domestic criminal justice officials must engage in the debate.  And actively.  And immediately.

Only governments can put into place enhanced investigatory assets and harsher penalties.

Public/Private cooperation?  Certainly.  But only governments can catch and keep criminals in jail.

When it comes to discouraging international prescription drug counterfeiting, what we need is a more robust cell culture.


I was saddened to hear that Senator Edward Kennedy was diagnosed with a malignant glioma.  This is a rare and usually fatal form of cancer with age adjusted five year survival rates of only 9 percent.     Gliomas constitute about half of all brain cancers and there has been progress against the disease particularly among children, no thanks to constant critics like Merrill Goozner and Maggie Mahar, both of whom see (without any medical background) see no value in any new cancer drugs.  Temodar, the first chemo drug for gliomas that could be taken orally was available in 2000.  It was immediately used in the US but rationed in Europe and Canada. 

Now it turns out that Avastin, the drug that Goozner and Mahar love to hate shows considerable promise in extending average progression free survival by up to nine months.   Contrary to the twisted narrative put forth by critics, the discovery of the off-label use of Avastin for gliomas came from academia without industry funding (which of course Goozner also criticizes...either way industry is damned,  pilloried for inventing useless new uses and attacked for not being innovative) 

Here's what happened:


"In the pilot study, the researchers found that dual therapy with Avastin and the chemotherapy drug irinotecan either shrank the tumors or restricted their growth in nearly all cases for up to three months longer than comparative therapies. Three months is a significant advance when dealing with these aggressive tumors, Vredenburgh said; common current treatment normally offers only six to 12 weeks of halted growth before the tumor grows and spreads, ultimately destroying cognitive and physical function and leading to death."

Following this discovery, Genentech, Duke University and NIH worked together to conduct an expanded study..  The FDA initially resisted because of side effects such as bleeding, but since 40 percent of all brain cancer patients experience bleeding for a fatal illness the risk seemed worth it (to everyone except Maggie  Mahar      www.healthbeatblog.org/2008/02/the-wall-street.html

James Vredenburgh, M.D., a brain cancer specialist at Duke's Preston Robert Tisch Brain Tumor Center and lead researcher on the study noted: "Going forward, we will also explore the efficacy of this treatment in newly diagnosed patients," he said. "Ultimately, our hope is that this will offer a real weapon in what is now a very limited arsenal for treating a very challenging cancer."

www.cancer.duke.edu/btc/modules/news/article.php

That includes patients like Senator Kennedy.  Let's hope that his doctors rely upon experts like Vredenburgh in making treatment decisions, not cynical second guessers like Goozner and Mahar who would let hatred of drug companies color life and death decisions. 
Former congressman Harold Ford, the Chair of the Democratic Leadership Council (DLC) along with Al From the DLC's executive director wrote an article proposing An American Center for Cures.  At first glance it looks like a big government takeover of drug development.  In fact, it is a reintroduction of bi-partisan legislation conceived by Senators Joe Lieberman and Thad Cochran in 2005 that takes the NIH Road Map program one step further: it creates nearly 100 portfolios and and federal funding for "small, flexible, entrepreneurial, and non-hierarchical, and empower portfolio managers with substantial autonomy to foster research opportunities with freedom from bureaucratic impediments in administering the manager's portfolios."   The goal is not so much to find cures but to train basic scientists in the art and science of clinical trials, drug development, translational research.  They are laboratories or farm systems design to fill a gap identified by the Critical Path: the inability to apply insights of discovery to drug development and the regulatory science. 

Ford and From describe the Center this way:

"The American Center for Cures would be a public/private partnership that would function as an independent entity within the National Institutes of Health, targeting research resources from government, academia and the private sector on cure-driven projects. It would pay for high-risk, high-reward research, fund small businesses that have created possible cures but lack the money necessary to test drugs in clinical trials, and work to streamline the clinical trial process."

There is a danger is politicizing science of course, (what else is new?) but if the ACC can roust the NIH out of its current torpor and shift resources towards more partnerships and clinical trial reform, it is worth a discussion.

I give credit to Ford and From for jump starting the discussion about biomedical research when no one else is talking about and understanding that health care is expensive because of a lack of cures.  I don't see Republicans offering anything new or exciting.  Kudos for their foresight and vision. 

www.dlc.org/ndol_ci.cfm

thomas.loc.gov/cgi-bin/query/F

 

Deal or No Deal

  • 05.27.2008
According to a Bloomberg report, biotechnology acquisitions and licensing deals reached a record $27 billion worldwide last year. In the largest deal of the year, London-based AstraZeneca paid $15.6 billion to acquire MedImmune.

Biotechnology companies also raised $29.9 billion in investments and loans, the most since 2000. The industry attracted a record $39.4 billion in 2000, the year the first draft sequence of the human genome appeared.

IPOs brought in $2.2 billion, a 21 percent increase over the previous year and the highest total since 2000.

The full Bloomberg story can be found here:

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a6FjDvLrCCgM

The article mentions that, “Large drugmakers are investing in biotechnology to gain new medicines to bolster revenue as patents on top products expire.”

No doubt.  But while acquisitions and licensing is the wave of the present, what will drive the future of pipeline, profit … and public health is the Critical Path.   To achieve “A” level health care, industry and academia and government must focus on “B” level issues -- Better science and better tools (biomarkers, bioinformatics, and Bayesian statistical analysis) among others.

So, deal or no deal, the Critical Path must not remain the road less traveled.

Red Sox southpaw Jon Lester pitched a no-hitter against the KC Royals tonight. For Lester the victory was more than a 7-0 whitewash of the Royals or his first complete game. It was a remarkable demonstration of how resoundingly Lester has bounced back after being diagnosed with non-Hodgkins lymphoma at the end of the 2006 season. Lester pitched the last game of the Red Sox world series championship last year but Lester, who hugged manager Terry Francona after the final out of tonight's game said: I've been through a lot the last couple of years. He's been like a second dad to me. It was just a special moment right there."

Read Boston Globe article

I have noted previously that other friends of mine have received combination of Rituxan and Avastin to treat NHL. (Other drugs for NHL such as Bexxar will hopefully grow in use as treatments are tailored to individual disease progression.) Both of those drugs were not and are not widely available in single payer health systems. Cynics like Merrill Goozner even believe Avastin is worthless. My advice as always is for people to receive medical care consistent with their ideological position and refuse medicines they believe were brought to market or marketed in ways that are corrupting or without the evidence they believe meets their utopian formulary. And don't let your family have access to the same drugs either.

Leave Jon Lester and the rest of us alone.
Merrill Goozner used to favor head to head comparisons of drugs as a precondition for reimbursement.  Now he see's them as a tool that drug companies can use to fool and befuddle government and insurance companies. 

"A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients."

www.gooznews.com/archives/cat_drugs.html

Goozner is referring to the Tier 4 payment category which by itself is crazy.  But all of a sudden comparative clinical trials are no good.  Maybe they should be bigger and government run.  Then there would be no drugs except the one drug selected by government to hit the market.  But wouldn't that create a  monopoly price?  No problem.  In the Gooz's world.  The price would be slashed by licensing out product to generic companies who would sell the rights to produce the breakthrough at pennies per dose. 

Because innovation all flows from government anyways and all the R and D and the marketing and education carried out by private companies is sort of just greedy rent-seeking behavior of the basest sort...  I would have no problem have a respectful debate on the best way to advance medical progress but Goozner and others want to shut off debate by attacking motives and funding sources.  As  I have noted, it cuts both ways but the media and the blogging world are intensely hypocritical on that score. 

One other Goozworthy note...He claims I don't support embyronic stem cell research.  He infers that because he asserts I am a conservative and CMPI is conservative and therefore assumes I hold down the line social conservative positions.  In otherwords, Goozner  who never bothered to check or ask me.  For the record, I support ESC research though I have tremendous respect for the positions of those that do not and I don't write about it because it is not an area that is CMPI's central focus. 
From the Brussels-based edition of The European Voice:

Doctors' protests are symptoms of a sick society


By Jacob Arfwedson

France has been the paragon among EU health systems. But the situation is changing, in France as elsewhere, as the medical profession comes under ever-greater pressure to ration services and to prescribe the cheapest drugs.

Corralling doctors has been an objective of French health policy for more than 20 years, with restricted entry to medical schools and financial incentives for early retirement.

The justification for such coercive guidelines around Europe is that unrestricted scientific progress and increasing demand for new treatments will make government healthcare unsustainable.

Restricting access to doctors or treatments frequently results in costly invasive surgery, and/or longer hospital stays. Good healthcare inevitably means people live longer, which inevitably increases costs. But is the unspoken position of finance ministries that they would prefer citizens not to live so long?

Doctors and patients are increasingly weary of government-imposed healthcare management systems that lead to waiting lists and one-size-fits-all treatments. Many seek care abroad: India and Thailand provide first-world care at third-world prices.

People value time and attention from doctors. In Belgium, most doctors spend at least 15 minutes with each patient and more than half spend more than 20 minutes. Belgians believe government has no place in regulating a doctor’s daily activity. Most French people feel the same.

Wrong-headed government attacks on standards are provoking protest among a profession with little natural inclination for going onto the streets. In Spain, physicians went on strike in 2007 to demand an increase of average consultation time from eight to ten minutes. Czech physicians went on strike in September 2007. In Italy, 5 million appointments and 45,000 surgical procedures were postponed in October 2007 when a 24-hour strike rallied 135,000 medical and non-medical staff.

Two-thirds of German doctors resent the interference that limits them to a maximum of ten minutes for most patients and that penalises them for prescribing expensive drugs. More than half the German public reckon they are no longer getting the optimum treatment from their doctors.

Doctors’ protests are symptoms of a sick system. Healthcare should be viewed not as a burden but as an investment. Market-based provision and financing is the only way to turn healthcare into the growth industry it should be.

Doctors have yet to make their voices heard in the battle of ideas between the guardians of socialised medicine and proponents of a free healthcare market. The outcome will shape the fate of their patients and their own profession. They can ill afford to ignore the debate.

Jacob Arfwedson is director of the Centre for Medicine in the Public Interest in Paris. Figures quoted are drawn from the recent 'The Hazards of Harassing Doctor', by Alphonse Crespo.


DTC? Mais non. ItP.

  • 05.27.2008
In our post-SiCKO environment, as Americans look to Europe to see how the other side of the pond is faring in 21st century health care policy, it's important to know the facts.

To that end, CMPI (the public policy home of drugwonks.com) is pleased to offer a new omnibus overview of what the EU refers to as "Information to Patients" (ItP) -- "Who wants to know?"

"Who wants to know" is written by CMPI senior fellow Jacob Arfwedson.  He's the chief of our Paris bureau.  A Swede who speaks French and German and writes in English.

And he's controversial in any (and every) language. 

To access "Who wants to know," go to  www.cmpi.org and look under "research papers."
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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