No Clinical Trials Please, We're British

• 06.26.2008

According to a report in the FT, “Leading pharmaceutical groups are cutting back on clinical research in the UK, claiming insufficient commitment by the government and the National Health Service to support new drug development.”

Pfizer of the US, Roche of Switzerland and Merck-Serono of Germany are among the companies which have told the Financial Times they have, or will, reduce the number of British patients enrolled in trials to test experimental medicines for life-threatening diseases such as cancer.

The result, the companies claim, is that few patients in Britain are receiving “gold standard” treatment -- so there is too small a group against which to compare their experimental drugs.

Add this to the list of the negative unintended consequences of HTA/Comparative Effectiveness.

The drug companies are increasingly frustrated by the National Institute for Health and Clinical Excellence, the government’s medicines advisory body, which on Wednesday handed them fresh setbacks by advising against NHS use of Pfizer’s Avastin and Merck-Serono’s Erbitux.

The warnings are a fresh embarrassment for the government, which has stressed its commitment to pharmaceutical research in the UK while imposing a fresh 5 per cost cut after unilaterally scrapping the existing price contract with industry only halfway through its five-year term.

Pfizer has already recently canceled UK participation in four clinical trials, including one for cancer, because it could not recruit sufficient patients who were taking the existing international “gold standard” approved drugs against which to compare with its experimental treatment.

NICE argues it approves most medicines and those that it has rejected have offered very limited value.

Really? Perhaps NICE should speak with Brian Turner, (Oaks Green Mount, Rastrick, United Kingdom) 74, who suffers from wet age-related macular degeneration in his left eye. He went blind in one eye after the NHS denied his request for Avastin. The NHS told Mr. Turner that treatment would only be approved if his other eye became affected and complete blindness was a risk.

Here's Brian telling his own story:

www.biggovhealth.org/testimonials/brian-turner/

And what about Dorothy "Dot" Griffiths (Stoke-on-Trent, United Kingdom), a breast cancer patient who, in July 2005, organized the advocay group "Fighting for Herceptin" and successfully lobbied the British Parliament after the NHS refused her request for the life-prolonging drug Herceptin because of ... cost of treatment.

Here's a link to Dot's story:

http://www.biggovhealth.org/testimonials/dorothy-griffiths/

Here’s a link to the complete story in today’s Financial Times:

http://www.ft.com/cms/s/0/f0e08f2a-42ee-11dd-81d0-0000779fd2ac.html

For more such healthcare “horror stories,” click here:

http://www.biggovhealth.org/stories/

And here’s a link to a new op-ed in the Journal of Life Sciences on the topic of what government-run healthcare provides – or doesn’t:

http://www.tjols.com/article-694.html

It’s time to tell the truth about Big Government Healthcare.

BigGovHealth Is Efficient

• 06.25.2008

On the heels of our www.bigGovHealth.org  launch comes this from Health Affairs:

Covering low-income people through public programs such as Medicaid and the State Children’s Health Insurance Program (SCHIP), rather than through private health insurance, results in lower per person medical spending and considerably lower out-of-pocket expenses for consumers. That’s the conclusion of a new study published today on the Health Affairs Web site, which looks at different ways of providing health insurance to Americans with family incomes below 200 percent of the federal poverty level. (For a family of four, 200 percent of the 2008 FPL is $42,400.) http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.4.w318
           

Has anyone been paying attention to what's been happening to access to care in public health programs here, Europe and Canada?  Not on the left where ideology trumps concern for patients:

Many states have used the same approaches to cover the uninsured and to make existing premiums less expensive. Instead of doing so, such proposals have driven many doctors out of government-run programs and have rationed access to new medicines. Private insurers are leaving markets. And patients who are forced to wait months for needed care often wind up not getting the medicines they need.

For example, Nicole Garrett's three teen-age children lost their private coverage, so she lost her private coverage and enrolled them in Michigan's managed-care Medicaid program.

According to a 2007 article in the Wall Street Journal by Vanessa Furhmans, when Nicole's 16-year-old daughter, Jada, needed to see a rheumatologist, the one listed in her managed-care Medicaid plan's network would not see her. Nicole notes, "When we had real insurance, we could call and come in at the drop of a hat."

Mr. Kennedy was rushed into surgery less than two weeks after his diagnosis. Jada's wait just for an appointment was a bit longer: The wait to get into a public clinic was more than three months. By the time she found a Medicaid-approved rheumatologist in a nearby county to take her in months later, Jada's debilitating pain had caused her to miss several weeks of school.

Edith Andrews of Zanesville, Ohio, faced the same problem when her twin girls, Sara and Samantha, were born prematurely nearly four years ago. Each weighed less than 3 pounds and needed a ventilator to breathe.

According to an article in the Cinncinnati Enquirer: "To get care she had to take her infants to a Zanesville clinic or an emergency room, where they saw a different doctor every time, if they saw a doctor at all."

When Sara's lung collapsed, Edith couldn't find a Medicaid pediatrician to care for her. "Sarah's complications got worse and worse, and there was never a doctor around when I needed to talk to somebody." She finally found a doctor to take her daughters on as patients after a year of searching.

Mr. Obama (and those providing support his approach in Health Affairs) would also create a new health board to create lists of "cost effective" new drugs and medical devices, and set prices for their payment. Similar review boards in Canada and Europe delay access to new medicines by months or years and are biased by cost-containment considerations.

In the Medicaid and SCHIP programs, such "preferred lists" have made it harder for people like Melissa Brown of Cincinnati to get the right drugs for her 6-year-old son, Max, who suffers from bipolar disorder and other psychiatric illnesses. Under private insurance, her doctor was able to choose a drug that controlled unpredictable and violent behavior. The drug treatment she got for Max "changed his life."

But now Melissa and Max are in Medicaid and bureaucrats, not doctors, will decide which drugs he will get, based on the cost-effectiveness standards Mr. Obama wants to impose on us all. Max will have to change his prescriptions and get authorizations for new medications...."

www.washtimes.com/news/2008/jun/17/obamacare/

And of course the public health system has worked so well north of the border for our new found friend Shona Holmes:

Shona began losing her vision in 2005 and got an MRI in Ontario that showed a brain tumour.  That was only after she had to wait three montns for an appointment for a neurologist and another for the MRI which was preceded with a misdiagnosis of the tumor as a stroke in the ER.   Forced onto a wait list (up to six months to see an endocrinologist) as her eyesight deteriorated, she went to the Mayo Clinic in Arizona where she eventually got surgery to remove the tumor.   The Canadian health system refused to pay for the care at Mayo which, if she had not received, would have meant death.   Now she and her husband have exhausted their savings to pay for the care they should have obtained without a fight and only paid 30 percent of their income in taxes for over the last 30 years.

Effficient?  If you mean by efficient reducing per patient costs by letting people die sooner by denying access to care. 

 

In Verbatim Veritas

• 06.25.2008

When Michael Moore came out with “SiCKO,” we realized that we had to counter his effort with our own.

We understood the need to fight anecdote with anecdote and make sure that we avoided Moore-ian hyperbole.

What we needed were patients from Europe and Canada who would be willing to share their personal stories about how Big Government healthcare let them down in their times of trial.

As it turned out, finding these patients, these people and their stories proved easy. In a word – Google.

It also made us wonder -- why haven't members of the American MSM done the same in order to balance their regular use of anecdotes portraying the glitz and glamor of EU/Canadian-style “universal” healthcare?

NOTE: That is a rhetorical question.

We also spoke with healthcare policy experts from the UK and Canada. Something else rarely seen in the MSM.

Then we had to decide whether or not to take on the same snarky tone as the Man from Flint. It was tempting.

But we didn’t -- because the patients we interviewed responded with such honesty and majesty that when they shared their stories of frustration, perseverance, and courage – we knew additional interpretation wasn’t necessary.

After all, if the patient is to be at the center of the healthcare conversation, so too must the patient be at the center of the story, or in this case BigGovHealth.org – the movie.

Here’s a link to our seven minute masterpiece:

www.biggovhealth.org/testimonials/highlights/

For additional footage on each of these patients and thought-leaders click on the appropriate video testimonial.

Everything else, as the Talmud says, is commentary.

Duh Real Truth About Drug Companies

• 06.24.2008

According to a new report from the Manhattan Institute, the vast majority of drug development takes place within the private sector and not, as some claim, in government-funded laboratories.

I know, duh – but it’s important to keep hammering home this point.

Based on the case histories of 35 widely prescribed drugs, researchers from the Manhattan Institute and Tufts University determined that almost all of the medicines they analyzed would not have been developed without private sector research.. And in 28 cases they found that private sector research led to improvements in a drug's clinical performance or to a better way to manufacture the drug. Discovery is cool. And so is development. One without the other leads nowhere.

According to an article in today’s edition of the New York Sun, “Dollar by dollar, the pharmaceutical industry outspends the government in drug development. According to the industry's main lobbying group, the Pharmaceutical Research and Manufacturers of America, it costs $1.3 million to develop a new drug. In 2007, the group's members spent $44.5 billion on research and development of prescription drugs, while the industry overall spent $58.8 billion. The same year, the National Institutes of Health allocated $28.6 billion in grants, some of which went to developing new drugs.”

I know, duh – but these are important facts to keep repeating and repeating in the appropriate context. Because there are those who chose to manipulate the facts to tell their own version of the truth.

And the NewSpeaker-in-Chief is Dr. Marcia Angell. According to her 2004 book “The Truth About the Drug Companies,”

"… drug companies no longer have to rely on their own research for new drugs … they rely on academia, small biotech startup companies, and the NIH for that."

Our friend Ben Zycher, one of the Manhattan Institute authors said Dr. Angell's argument is a "curious" one.

"If they don't come up with scientific innovation, what are they spending all this research and development money on?" he said, referring to pharmaceutical companies.

Well, duh.

Here’s a link to the complete article in the NY Sun:

http://www.nysun.com/new-york/capitalism-said-key-to-finding-new-drugs/80569/

Here’s how the article ends:

A former associate commissioner of the U.S. Food and Drug Administration, Peter Pitts, said it would be hard to say which sector's work was more important. “A discovery is a discovery," Mr. Pitts, who now serves as president of the Center for Medicine in the Public Interest, said. "I think the most important thing to understand is that a lot of people think the government discovers drugs and the industry sells them, and that's not true," he said. "But industry and government need to work together to make sure drugs get to the public in a safe way," he said.

Well, duh!

Launching a Barrage of Reality

• 06.24.2008

HL Mencken said, that “for every complex problem there is a solution that is simple neat – and wrong.”

And a perfect – and perfectly frightening example of this is the movie “SiCKO” and it’s simplistic and calculated portrayal of how other nations provide healthcare.

Michael Moore made the British National Health Service (the NHS) and the Canadian health system particular exemplars of excellence.  And he backed it up with a lot of statistics.  But statistics, as the saying goes, are like a bathing suit.  What they show you is interesting, but what they conceal is essential. Statistics alone, and without context, is not research.

And what “SiCKO” concealed was that systems such as those in the UK and Canada are cost-based rather than patient-centric models.  The devil is the details. Facts, no matter how inconvenient to one’s argument must not be ignored.

Citizens of countries with government-run health care systems experience long wait times, a lack of access to certain treatments and, in many instances, substandard medical care.  For example:

• The five-year survival rate for early diagnosed breast cancer patients in England is just 78 percent, compared to 98 percent in the U.S.
  
  
• A typical Canadian seeking surgical or other therapeutic treatment had to wait 18.3 weeks in 2007, an all-time high, according to The Fraser Institute.

• The average wait time for bypass surgery in New York is 17 days compared to 72 days in the Netherlands and 59 days in Sweden. 

• More than half of the Canadian adults (56 percent) sought routine or ongoing care in 2005 – of these, one in six said they have trouble getting routine care.
  
  
• Eighty-five percent of doctors in Canada agree private insurance for health services already covered under Medicare would result in shorter wait times.
  
  
• Approximately 875,000 Canadians are on waiting lists for medical treatment.

If we’re going to look to other healthcare models for solutions, so too must we uncover and study their problems.

Healthcare is too important to allow reform by soundbite

Last autumn, the Center for Medicine in the Public Interest interviewed people on the streets of New York City and asked them if they’d prefer “government” healthcare or “universal” healthcare.  They overwhelmingly chose “universal” healthcare – but when we asked them to explain the difference between the two, they generally just shrugged their shoulders. See for yourself at http://www.youtube.com/watch?v=CnvQt587TPY

And when we asked them how much more in taxes they’d be willing to pay to support universal healthcare, they shook their heads and said, “No, we want it to be free, like in Europe and Canada.”

Such are the fallacies that political rhetoric hath wrought.

Equally as prevalent is the notion of “free” or “low cost” drugs “like in Canada and Europe.” And here too we need to be honest and examine the other side of the coin – that of cost-savings for the payer (often in the guise of healthcare technology assessment programs such as Britain’s NICE (the National Institute for Health and Clinical Excellence) versus care denied for the patient – that price controls equal choice controls.

And so, as we enter into a presidential election campaign with healthcare reform as a top agenda item, the Center for Medicine in the Public Interest is excited to announce an initiative we call “BigGovHealth.org” -- the first salvo in what we hope will evolve into a barrage of reality on ways to reform the American healthcare system in ways that keep patients at the center of the conversation.

Our national conversation about healthcare has to go beyond vague concepts of reform and convenient political rhetoric.  We must all be part of the solution. 

As Governor Deval Patrick commented at the BIO convention last week, “Be very suspicious about false choices.”

Here’s what Congressman John Shadegg (R, AZ) had to say at yesterday evening’s National Press Club  launch  of BigGovHealth.org:

“Congress has an important role to play in health care reform” said United States Representative John Shadegg (R-AZ), who has introduced health care legislation in support of free-market competition.  “We can help patient in this country, not by setting up a massive new government bureaucracy, but by empowering individuals to make the best choices for themselves and their families.”

Indeed.

To learn more about why government-run health care is not the right prescription for reform in the United States, please visit www.BigGovHealth.org.

What's Behind the Paxil Investigation?

• 06.23.2008

There's money in it, maybe for the plaintiffs attorneys.  But there is also the Holy Grail of overturing FDA pre-emption.  Here is the logic driving the extremists in the tort community justifying yet another assault on the thin reed that Glaxo somehow deceived the FDA and the entire psychiatric community on the basis of one small (published study)  but for the lack of intervention of trial attorney discovery power:

The reason that jury decisions may be superior to FDA decisions is that jurors often have superior information upon which to base their decision. Thanks to the discovery process, jurors often see reports, memos, and emails that pharmaceuticals specifically chose not to send to the FDA, such as internal concerns over drug safety and efficacy. Perhaps this wouldn’t be so if Congress chose to grant the FDA subpoena power.

www.tortdeform.com/archives/2008/06/critiquing_the_economic_argume.html

Makes sense to me.  Jurors have infinite wisdom because they  have infinite power to dredge up every piece of paper a tort lawyer regards as relevant to their case which in turn leads to a bigger, better supply of newer, safer medicines....

Repack Attack

• 06.23.2008

The pharmaceutical industry in Europe is calling for a ban on the repackaging of medicines within the European Union in order to stamp out the growing threat of counterfeits.

This is not a new idea – but it’s a good one. But it’s often derided as the pharmaceutical industry calling for a policy change for reasons of self-interest rather than public health.

But at last weeks BIO convention in San Diego a European Commission representative said that Brussels is seriously considering proposals that would ban repackaging – a move that, if taken would (according to Reuters), “deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.”

Does this mean that the European Commission is in the “pocket of Big Pharma?”

Hardly.

(In fact, it’s humorous considering the way the industry is treated over there.)

What it does mean is that, enfin; the EC is taking seriously what we here at drugwonks.com have been saying for some time – that parallel trade is the weak link in the pharmaceutical chain of custody and a prime target for counterfeit infiltration.

It’s also important to note that what the Europeans call “parallel trade,” we refer to as “importation.” And that Canadian Internet pharmacies get their drugs from Europe. (Note: over 20% of all pharmaceuticals legally sold in the UK are parallel traded into that island nation from other nations within the EU such as Greece, Latvia, Portugal, and Malta and often illegally from places such as Russia and Turkey.

“Safe” importation?

Perhaps in a parallel universe.

hcrenewal responds

• 06.20.2008

Sorry to healthcare renewal blog for getting their url wrong.  That's not as bad as 1) failing to directly engage in serious debate and then 2) posting comments to say you engage in debate when you really don't. 

I usually don't live in the past but since Dr. Poses is fairly well-intentioned and we actually see eye to eye more or less on the how comparative effectiveness should be conducted, constructed and used (I think?) I because he is real doctor I just want to point out the following regarding his criticisms about my article in The Washington Times on comparative effectiveness.

1.  He beats up on me for conflating hypertension with congestive heart failure in discussing BiDil.   I hereby announce that he wins this one.  BiDil was first rejected as a treatment for hypertension but approved later for advanced heart failure because of clinical measures, not surrogate measures that everyone drools about these days.   I then compounded the mistake by hauling up examples about how one uses the combination of drugs in BiDil (isosorbide dinitrate and hydralazine) are used to treat hypertension. 

2,  But then Poses goes to nitpick on my analysis of ALLHAT rather than engage me at the larger point I was trying to make: that the same people who were beating up on the use of BiDil which was designed to target excess mortality from CHF in blacks had no problem with ALLHAT which had a design that lead to excess stroke and mortality due to heart failure -- all in the name of well-designed comparative effectiveness and we urging even more ALLHAT like research to guide FDA and insurance reimbursement decisions.  

3.   I won't use time or space now to respond to the Poses nitpick on ALLHAT: that I am wrong to claim that the ALLHAT study design except to say that when African American blood pressure levels are beyond acceptable levels and they are generally deprived of optimal care as part of the study protocol I will leave it to Poses to defend excess mortality among blacks and Jerry Avorn's peddling of the ALLHAT results as the gold standard for comparative effectiveness...which I frankly think Dr. Poses does not want to do.  If he wants to go in depth on the ALLHAT mess I can refer him to other who were and are actually involved. 

4.  In short, I believe Dr. Poses to be much more fair minded and rigorous than many others, more driven by data and science than by ideology.  I may be wrong on that point but my re-reading of his criticisms of me and his post suggests that.

hcrenewal.blogspot.com

Rethinking and Regurgitation on Gift Ban

• 06.20.2008

It always happens.  As calmer heads prevail and political reality sets in, the radicals are tossed under the bus.  The radicals, in turn, fulminate and issue press releases that border on hysteria.

Thus:

By Jim O'Sullivan,
Catherine Williams, and Michael Norton
STATE HOUSE NEWS SERVICE

SAN DIEGO, JUNE 18, 2008......A controversial Senate plan to forbid
gifts from pharmaceutical companies to health care workers appears
unlikely to survive intact, as Massachusetts state leaders have caught
an earful from industry executives while attending an international
biotechnology convention this week.

The plan's leading proponent, Senate President Therese Murray, said
researchers have told her the ban would prevent productive interactions
between doctors and researchers who are trying to treat the same
diseases.

"It's something that we didn't discuss when we did it, because we were
looking purely at gifts to doctors," Murray said in a telephone
interview with the News Service. "But the fact is that some of these
companies do bring researchers and doctors together to go over the
latest research."

"Through what we did, in their explaining, there are many things they
won't be able to do that are important to science," she said.

www.statehousenews.com

Whatever that means...

Meanwhile, the Prescription Project backed  CEJA recommendations Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine were soundly rejected  Which led Daniel Carlat to become completely unhinged and attack Medscape and George Lundberg as a CME tool.   Very mature.   carlatpsychiatry.blogspot.com/  

And on the heels of the resounding defeat the munchkins at the Association of American Medical Colleges had to issue a press release re-cycling the release of a study on CME which had to acknowledge there limited evidence of bias in CME or that sampling  has any influence on prescribing practices.  Then there is the underlying assumption that industry-based research is defacto corrupt, tainted and incorrect and information coming from centralized academic sources is pure.  Yeah, right. 

Can't wait to take this one on. 

Conflict of Interest Capos Reveal Their Bias

• 06.20.2008

The Prescription Project released a survey this week claiming that a majority to disclose of gifts and payments to physicians.  Of course, what the poll didn’t ask (and maybe drugwonks will ask the question) if doctors should be jailed or sued for taking a pizza or if people really think doctors are brainwashed by pens and cups or that academics who are on retainer to trial attorneys who sue drug companies should do it…) 

Which leads to my next point.


Hardly a chirp from the conflict of interest capos regarding the following:

The biases of the Prescription Project, namely being packed full with the usual suspects: those who are already behind the effort to extend government regulation of marketing, development, review and prescribing of medicines as well as congressional legislation to overturn FDA pre-emption.  I guess a conflict only occurs when an academic researcher partners with pharmaceutical scientists….

Well since neither pharmalot, Carlat or Healthcarerenewal have the intellectual integrity to do so, here are the people associated with The Prescription Project and their “biases”:

Robert Restuccia, Executive Director

Restuccia is also executive director of Community Catalyst, Inc. a left wing advocacy group.  Community Catalyst runs the Prescriptin Access Litigation Project which has “been involved in 26 class action lawsuits challenging drug industry tactics to illegally raise the price of prescription drugs.”  PAL receives money from these settlements.  One of the law firms that was representing PAL is the now discredited Milberg Weiss law firm that pled guilty in a multi-million dollar kickback case.  And the conflict of interest capos like playing connect the dots?

David J. Rothman, Associate Director

President of the Institute on Medicine as a Profession which receives funding from George Soros and which has repeatedly called for bans on gifts and grants to physicians from industry.  Rothman is also a mover and shaker behind the increasingly shrill attacks from Association of American Medical Colleges, writing editorials on behalf of articles written by AAMC staff in JAMA on the evils of industry-academia associations.

It turns out that the Greenwall Foundation – which supports Rothman – has a certain Troye Brennan on its board.  That’s the same Troyen Brennan who co-authors work with Rothman and collaborates with him on projects.

Advisers of the Prescription Project include

Jerry Avorn Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital

Avorn has his own for profit academic detailing business that has a contract with the state of Pennsylvania.  He stands to benefit from any ban or cutback by a reduction in industry sponsored CME.

Steven Nissen, M.D. Immediate Past President of the American College of Cardiology

Need I say more?

Cathy DeAngelis, M.D. Editor-in-Chief of the Journal of the American Medical Association

Is it ethical for the editor of a major medical journal to be part of an advocacy organization, particulary one that is associated with litigation for pay purposes? 

Sharon Levine, M.D.  Associate Executive Director of Kaiser Permanente

Levine is in charge of Kaiser Permanente North.  PP fails to disclose that Levine believes that it is just fine to use formularies and co-pays to limit utilization of drugs even though evidence has clearly shown a decline in utilization is associated with discontinuities in treatment. 


Stephen Schondelmeyer, Pharm.D., Ph.D. Department Chair of Pharmaceutical Care and Health Systems, University of Minnesota College of Pharmacy

Schondelmeyer has long been a recipient of funding from generic drug companies and the generic drug trade group.  He is also a consultant to PAL and trial attorneys.  Though chair of a college of pharmacy, he has been lead author of only one article  published in a peer-reviewed professional publication in the past 20 years:  "Pharmacists' compensation and work patterns, 1990-91."