Latest Drugwonks' Blog

According to an opinion piece in The Guardian newspaper, “If you suffer from epilepsy and you live in Athens you are less likely to receive the vital drugs you need for treatment than if you live in London, Berlin or Amsterdam. And, says Konstantinos Lourantos, president of the Association of Pharmacies of Attica, the fact that they are freely available in other parts of Europe contributes to their shortage in his country. The reason? Lourantos, whose organisation represents some 3,500 pharmacists in and around Athens, blames companies that buy up medicines in Greece and export them to other EU countries, exploiting the price differences for drugs across the EU.”

Lourantos says: 'For example, there is a medicine called Lamictal for epilepsy which is imported to Greece but it is re-exported in such a huge quantity that there is very little left.' He says the problem affects supplies of a number of drugs, including Astra Zeneca's Seroqual for treating bipolar disorder and Risperdal, an anti-psychotic treatment.

Here’s a link to the complete story:

Guardian Story

My eldest son has epilepsy. I don’t want his access to the medicines he needs to lead an active life to be on the backs of those in other countries who have their drugs pirated away by parallel trade arbitragers.

Whether you call it parallel trade in the EU or "drug importation," on the Presidential campaign trail -- it's still pharmaceutical imperialism.

ie-7

  • 06.27.2008
If you don't know if you are being manipulated than how can you tell if it's you that are being controlled by outside forces or someone else? If everyone is unconsciously being biased without knowing it how can we really judge what is right or wrong apart from the shadowy influences. And who or what is controlling those influences we think are controlling those influences we think are subversive?

This from the mind of Catherine D' Angelis, Editor D' Jefe of JAM, courtesy of Tom Sullivan's Policy and Medicine blog:

Medical schools and professional medical associations have developed policies and guidelines in response to increasing concerns over potential conflicts of interest.

While many physicians agree with these concerns, some view conflict-of-interest policies as affronts to their integrity and an indictment of the ethical conduct of the profession as a whole. These individuals believe that their training as scientists and their devotion to professionalism protects them from external influences that might bias their opinions.

However, this view may be based on an incorrect understanding of human psychology. Conflicts of interest are problematic, not only because they are widespread but also because most people incorrectly think that succumbing to them is due to intentional corruption, a problem for only a few bad apples.

In this Commentary, we argue that succumbing to a conflict of interest is more likely to result from unintentional bias, something common in everyone. We review studies in neuropsychology, behavioral economics, cognitive psychology, and clinical epidemiology to illustrate this point."

All of which means there is no escape from conflict and therefore no end to regulation or thought control. Which begs the question: if that's the case, what qualifies the equally corrupted D' Angelis and her ilk for ruling over the everyone else?

www.policymed.com/2008/06/jama-everyones.html
We recently interviewed Representative Marsha Blackburn (R, TN) on her views about healthcare reform.

Have a look:

View video podcast here

According to the Wall Street Journal, “European Union investigators are widening a probe of the pharmaceutical industry as they look into whether drug companies have used unfair tactics to block competition and prop up prices.”

The EU sent questionnaires to drug wholesalers and trading firms, asking them about pharmaceutical companies' distribution methods and other practices.

That’s kind of like asking the Association of Hungry Foxes about chicken coop security regulations.

Specifically, the EU is asking about the distribution methods drug companies’ use in Europe, and whether they are blocking competitors from distributing medicines.

Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies, the trade group representing parallel traders, says EU investigators sent him a questionnaire in mid-May asking whether drug companies were using litigation or other tactics to thwart parallel trade.

So, Mr. Wylie E. Coyote, what do you think of the business practices of Mr. Roadrunner?

According to the Journal report, “Mr. Kobelt said the questionnaire asked for his group's views on so-called direct-to-pharmacy distribution channels, which Pfizer Inc. and AstraZeneca PLC have recently established in Britain. Direct-to-pharmacy channels differ from traditional distribution in that the drug company pays wholesalers a set fee to deliver goods to pharmacies, rather than selling to the wholesaler. The drug companies say the approach helps them keep better control over their goods and prevents counterfeit medicines from getting into pharmacies. Wholesalers say big pharmaceutical companies are trying to prevent parallel trade, a charge the companies deny.”

Is this the debate then? Big Pharma trying to reduce fraud and counterfeiting versus parallel traders who want to protect their profits? What’s best for the consumer?

Relative to the value of parallel trade, consider the insights of. W. Neil Palmer of RTI Health Solutions. (By way of bona fides, Neil has served as a senior official with the Canadian Patented Medicine Prices Review Board -- the dreaded PMPRB -- as well as with the Health Division of Health Canada, and the Kellogg Centre for Advanced Studies in Primary Care in Montreal.)

His take on the European experience with parallel trade:

* It is not the policy of EU governments to use parallel trade to deliver savings to their individual health care systems.

* Because savings are not passed on to consumers and payers.

* Patient care may be jeopardized because of quality, supply chain integrity and regulatory compliance issues -- as well as potential shortages occurring in exporting nations.

* Increased parallel trade results in decreased competitiveness of the pharmaceutical industry in local markets. And, since the profits of the parallel traders aren't reinvested into R&D, opportunities are lost for the patient, the local health care system, and the economy.

As far as safety goes, its been proven time and time again that parallel trade is the weak link in the European pharmaceutical chain of custody. Counterfeiters know it and so do national authorities across the EU.

For more on this issue, see here: www.drugwonks.com/blog_post/show/5362

Perhaps the EU is investigating the wrong people?

The folks from the Drug Effectiveness Research Program, on retainer to Agency for Health Care Research and Quality and who set the de facto reimbursement guidelines for Medicaid preferred drug lists also recommend co-pays as a way to steer people into other drugs. Guess what?

Prescription use dropped about 17% after introduction of policy, Oregon study finds

Posted June 26, 2008

THURSDAY, June 26 (HealthDay News) -- Adding small co-payments to Medicaid prescription drug plans reduces the use of medications by patients with chronic diseases, says a U.S. study.

Daniel M. Hartung, of Oregon Health & Science University, and his colleagues analyzed the effect of small co-payments -- $2 for generic and $3 for brand-name -- for prescription drugs introduced for Oregon Medicaid enrollees in 2003. The co-pay fees weren't required for patients who were unable to pay.

The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes.

The patients' overall use of prescription drugs decreased by about 17 percent after introduction of the co-pay policy.

"Subjects with chronic diseases were less likely to reduce the use of drugs used for that disease compared with drugs not for that disease," the study authors wrote.

Most state Medicaid programs now use co-payments to help control prescription drug costs, but few studies have examined how these co-payments affect medication use, the researchers noted.

"This study suggests that in response to cost-sharing, patients discriminate what therapies they reduce based on the diseases they have," they wrote.

The study was published in the June issue of Medical Care.

In Oregon, co-payments for some outpatient services were introduced at the same time as the drug co-payments. But there were no significant changes in the use of those outpatient services, the study found.

This comes on the heels of other studies showing that decreased drug use is associated with a spike in illness...

Where are those geniuses in Health Affairs who said Medicaid was the most efficient way to provide coverage for more people now? Along with the rest of the Left they are willing to sacrifice the quality of life of the people they "care" about to implement their program...

The same goes for those who see comparative effectiveness as a cost containment tool...

Read Article here

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.

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.
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!

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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