European Commission Calls for More Healthcare Cowbell

• 10.03.2008

Too slowly for some, too swiftly for others, and without any apparent interest by most, the European Commission is moving forwards in its efforts to lubricate the anemic channels through which pharmaceutical companies can communicate with patients (otherwise know as “people”).

According to an article in Europolitics, “The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products.

The full Europolitics article follows – but here are some tidbits to whet your appetite:

 “The idea is also to respond to the expanding use of communication tools - in particular the internet - and patients' growing responsibility for their treatment.”

 Wow.  Reality.  What a concept!

 “While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients.”

But:

“The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information".

However:

“… the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders."

So, there can be advertising , but not advertising.

And for all you DDMAC fans out there:

“The European Agency for the Evaluation of Medicinal Products (EMEA), based in London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.”

And to make things even more confusing:

“For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'.”

Note:  This is the difference between federation and confederation.  It is also a lesson in why concepts like … preemption ... are so important. But I digress.

Here is the compete article from Europolitics:

Prescription Drugs: Pharmaceutical Firms Authorised to Inform Patients

The European Commission is standing firm on its objective of authorising pharmaceutical laboratories to communicate directly with patients on the benefits and risks of their prescription products. In a draft directive due out in late October(1), the EU executive is expected to stand up to the criticisms of health care professionals, sickness insurance bodies and several patient and consumer organisations, which accuse it of trying to do away with the European ban on advertising for prescription drugs.

With this proposal (subject to co-decision), of which Europolitics obtained a copy, the Commission intends to iron out the differences between national laws, which range from allowing information that is strictly supervised by drug regulatory authorities, to public private partnerships between health care professionals, patient associations and industry.

QUALITY CRITERIA

While the Commission has always denied wanting to authorise advertising for prescription drugs, it was expected to make a clear distinction between non-professional information' and advertising' if the industry is allowed to communicate directly with patients. Its answer is that "the content of authorised information must be defined". According to the proposal, industry would be authorised to communicate on the instructions for drug use, prices, changes in packaging, warnings on side effects, the absence of scientific studies and prevention and treatment support measures. Information on human health and illnesses as such is not concerned.

Quality criteria are established: the information must be objective and non-biased, take patients' needs and expectations into account, be based on factual and verifiable data (declaration on the extent of evidence), up-to-date, reliable, factually accurate and not misleading, comprehensible to patients and the general public, stem from a clearly identifiable source and compatible with the summary of product characteristics and patient information brochures as approved by the competent authorities. Comparisons between drugs are prohibited.

INTERNET AND PRINT MEDIA

The EU executive took a step backwards, however, on communication channels: exit radio and TV broadcasting, which "does not protect patients against unsolicited information". This eventuality, discussed by the Commission in its public consultation documents, was rejected by the member states, even the most liberal stakes like the

UK, but also by laboratories. The European Federation of Pharmaceutical Industries and Associations (EFPIA), for example, had informed the Commission that its members did not wish to engage in direct advertising as in the United States and that reflection on passive information via TV, radio and the print media tied into that. However, the Commission intends to maintain the print media in its proposal. It nevertheless puts emphasis on the internet, saying it offers "almost unlimited access to information without taking account of national borders". And it adds that "specific rules on site surveillance should be put in place to take account of the cross-border nature of the information provided on internet and to allow cooperation between member states". Patients could, for example, write to industry in any of the EU's 23 official languages to request information in that language.

EX-POST MONITORING

For the monitoring of information, the Commission is expected to propose an ex-post mechanism (after dissemination of information to patients). The member states will define the rules. They could nevertheless set up prior monitoring - and clearance by the competent authorities - for information for which it is hard to make a distinction between non-promotional information' and advertising'. The national authorities will have to ensure that information is accessible to people with disabilities, unless this requires too much paperwork in laboratories. Such a regulated mechanism nevertheless does not rule out voluntary regulation by industry or co-regulation by industry and the public authorities. At a debate in the Health Council, on 10 June in

Luxembourg, most of the member states expressed a preference for prior monitoring of information. Sweden noted, however, that possibilities for ex-post monitoring could lower the administrative costs involved (see Europolitics 3548).

It will also be for the member states to ensure that companies are fined or taken to court for "repeated and serious cases of non-compliance" with the new rules. The name of the company would be made public. The European Agency for the Evaluation of Medicinal Products (EMEA), based in

London, would also play a role: laboratories would have to notify their information prior to publication and the EMEA would have 60 days to express any compliance objections, after which the information would be published.

The Commission also gives itself the possibility to revise the directive five years after its entry into force. The proposal concerns only prescription drugs, since existing EU rules authorise advertising by laboratories for over-the-counter drugs, under certain conditions.

Jenny McCarthy Can Promote Autism Cure But Docs Focus on OTC Cold Medicines

• 10.02.2008

Here's what happens when drug companies become a convenient whipping boy for media hungry public health officials and a pliant media plays along:

Jenny McCarthy has stated that with a change in diet and vitamins, her autistic son has been 'cured' - but some parents are not happy about her 'cure' statements. Jenny McCarthy's son, Evan, has been put on a special diet and has been receiving vitamin B-12 shots - and Jenny says the regimen is really working.



"I've been speaking to moms across the country who are all shouting out the same thing: 'This (diet and supplement intake) is working," Jenny says.

"It's so heartbreaking to see the medical community not support something called diet and vitamins. And it pains us, city after city after city. I see this heartbreak on these mom's faces."

Click Here to Read More

Related Article: 

"FDA urged to recall cold medicines for youngsters"

Sarah Palin Revealed.....

• 10.02.2008

She has a real record on health care as I have noted before and compared to Obama's, it's much better...

Click Here to Read More

Load Gun. Shoot Foot.

• 10.02.2008

Nothing like a self-inflicted wound to start your day.

Today’s Washington Post reports that the FDA awarded a no-bid, $300,000 contract for public relations services. “The plan used a circuitous route around the standard government contracting procedures. The contract was awarded in July to Alaska Newspapers Inc., a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides. The idea was for ANI to hand over the work to Qorvis Communications …” (a Washington, DC public relations firm). 

So, not only was it a no-bid contract, it was a sham one as well – hiding an inside-the-Beltway public relations deal behind the façade of a contract with a minority contractor from Alaska.  (Anybody out there miss the irony?)

After being made aware of The Post's findings, FDA deputy commissioner John Dyer said he had suspended the contract and ordered an independent investigation.

Too little too late.

And check out this amateurish spin -- Qorvis’ Don Goldberg told the Post that “It was not appropriate (for the FDA) to hire Qorvis directly.”  But it was okay for the agency to hire Qorvis indirectly -- via an intermediary that has no relevance to the task?  Come on.  And, get this – Goldberg leads Qorvis’ crisis communications practice!

When I was at the FDA as Associate Commissioner for External Relations, my budget for public outreach was zero dollars.  We did consider hiring an outside PR agency and did what the agency is supposed to do – issue an RFP for the assignment.  (We opted, at the end of the day, not to hire an agency.) And the budget at the time was $30,000 – ten times less than the no-bid Qorvis deal.

For the FDA to issue a shady $300,000 no-bid contract for any service is wrong – to do so for public relations services is tragic.  

Embarassing.  Foolish.  Damaging.

And needlessly so.

Substitute Teacher

• 10.01.2008

Feral Merrill

• 10.01.2008

That plain speaking Texan, our buddy Merrill Matthews of the Council for Affordable Health Insurance (he's also a resident scholar with the Institute for Policy Innovation) tells it like it is.

Check out his op-ed in today's edition of the Wall Street Journal:

McCain Is Right
On Interstate Health Insurance

Let's hope Democratic presidential candidate Barack Obama understands more about financial markets than he does about health-insurance markets. But the initial evidence isn't promising.

A recent kerfuffle between Mr. Obama and Republican presidential candidate John McCain concerned the interstate purchase of health insurance. Mr. McCain wants to allow people to buy health insurance across state lines. Mr. Obama, on the other hand, opposes the idea and seems to believe it would create an unsafe, unregulated health-insurance market.

Mr. McCain backs legislation sponsored by Arizona Rep. John Shadegg. Known as the Health Care Choice Act, it would allow individuals living in one state to purchase health insurance being sold to people living in other states. The policy would still have to meet the regulations of the state in which it is being sold, and would be subject to additional federal oversight.

In other words, the McCain-Shadegg reform would allow a person living in New Jersey or New York to buy health insurance that is being sold in and regulated by Pennsylvania or Connecticut. That's hardly the Wild West of health insurance.

About 18 million Americans today buy health insurance in the individual market because they don't have access to employer coverage or they aren't in a government-sponsored program (Medicare, Medicaid, etc.).

Many people in the employer-provided group market -- about 160 million Americans -- can already get health insurance across state lines. As a senator Mr. Obama, for example, lives in Illinois, but can get his health insurance through the Federal Employees Health Benefits Program, which is not located in Illinois.

In addition, lots of small employers who offer health insurance through state-regulated insurers have employees who live in other states. And when my youngest daughter moved from Texas to New Jersey to go to graduate school, she remained on our family's Texas-regulated health insurance.

In fact, people living in one state who buy health insurance in the individual market often move to other states, carrying their insurance policy across state lines.

Almost no problems have arisen from all of these interstate coverage options. So why are the two presidential candidates fighting about expanding interstate health-insurance options?

Mr. McCain recognizes that millions of Americans, many of them uninsured, live in states that impose numerous mandates -- there are about 1,900 mandates nationwide -- and restrictions that make health insurance unaffordable. Mr. McCain's proposal would simply let individuals faced with high prices and few options in their own state buy a regulated policy in another state.

That's how other industries work. People buy just about everything across state lines, with very few problems.

Mr. Obama ignited the latest feud by telling an audience, "So let me get this straight -- he wants to run health care like they've been running Wall Street," according to the Washington Post, implying that Mr. McCain would relax insurance regulations.

Mr. Obama opposes interstate sales for two reasons. First, he doesn't believe a market can work in health insurance. He believes it is necessary for the government to look over everybody's shoulder to make sure patients are getting the care and coverage the government thinks is appropriate at a price the government considers affordable.

Second, Mr. Obama likes benefit-rich policies that cover virtually everything, but are also very expensive. He wants people to have the types of health-insurance plans that the uninsured can't afford. He will "solve" the affordability issue by imposing price controls and regulations on insurers and drug companies, and force taxpayers to subsidize the rest of the cost.

Creating an interstate option for individuals to purchase health insurance doesn't solve every problem faced by the 45 million Americans who are uninsured. But the choice isn't between a regulated or unregulated health-insurance market. The choice is between an overregulated market favored by Mr. Obama and a regulated market favored by Mr. McCain that provides more options to help individuals afford health coverage.

Physician Disempowerment: A Transatlantic Malaise

• 10.01.2008

William Osler, generally regarded as the father of modern medicine wrote, "If you listen carefully to the patient they will tell you the diagnosis."  It's interesting to note that Dr. Osler was Canadian. One wonders what he would have thought of government interposing itself between doctor and patient.

To explore that question, the Center for Medicine in the Public Interest (the public policy home of drugwonks.com) will host  "Physician Disempowerment:  A Transatlantic Malaise," a conference on how cost-based government-run health care results in physicians having less control over the practice of medicine -- and the consequences thereof.

The event will take place from 9AM through 1PM on October 14 at the Newseum in Washington, DC.

Here's the invitation. 

The fact that this event is being held one day before the final presidential debate, where health care is slotted as a major focus, is not by accident.

Policy thought leaders and physicians from the US, Canada, Sweden, Switzerland, France, and Germany will discuss the issue of physician disempowerment -- and what it means to both the practice of medicine and patient care.

The opening keynoter for this conference will be Francois Sarkozy, MD (yes, the brother of Himself).

There is no fee to attend and we hope to see you there.

Some Tea Party

• 09.29.2008

On December 18, 2003 Thomas Menino, Mayor of Boston, came to the FDA for a discussion of drug importation.  I was there.

I was there to hear the mayor lecture us on internet pharmacy safety.  I thought he was there to engage in a dialogue.  I was wrong.  He was there to grandstand.

Here’s how our meeting was covered in the Boston Globe on December 19^th:

And again a few days later on “Your World With Neil Cavuto.” 

How times change. According to a story in last week’s Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”

In late July of 2008, the Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.

But, as they say, denial is more than just a river in Egypt.  As the Globe reports, “Boston City Council member Michael Ross said he believes the city was forced to abandon the program because of federal pressure. The Food and Drug Administration strongly opposed efforts by cities and states to offer Canadian prescription drugs, saying the suppliers were not regulated by the United States and that the safety of the drugs could not be guaranteed.”

Yes – we did say all those things.  And that remains the position of the FDA.  And it's the correct position.  As to the reason Mayor Menino's program failed you can, as the Ol’ Perfessor used to say, look it up  -- only 16 participants.

Some tea party.

Mental Health Parity Stalls In Senate: No One Blames McCain

• 09.26.2008

The bad news is that the mental health parity bill that passed the House of Representatives is stalled in the US Senate.  The bill was a separate piece of legislation in the House but it is part of a larger tax bill in the Senate that, if voted on would open up the entire package to amendments. 

As if anyone has any new money to spend or tax breaks to give these days.... Then again, putting mental health coverage on par with other coverage would cost the treasury $3.4 billion (at least) over ten years.   Again, not if $1 trillion is borrowed and allocated to buy up securities of unknown value....

At least no one blamed John McCain for the holdup...

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=54661

Now This Is Really Depressing

• 09.26.2008

Why worry about whether the proposed bail out of Wall Street will give consumers the shaft when you can....well,  see below: 

ntidepressants may damage male fertility

Last Updated: 2008-09-24 15:19:18 -0400 (Reuters Health)

LONDON (Reuters) - Common antidepressant drugs may reduce some men's fertility by damaging the DNA in their sperm, according to scientists.

A study of 35 healthy men given paroxetine - sold as Paxil or Seroxat by GlaxoSmithKline - found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.

Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. The research by Peter Schlegel and Cigdem Tanrikut of the Cornell Medical Center in New York was reported in New Scientist magazine and is due to be presented in November at a meeting of the American Society for Reproductive Medicine.

A copy of the study abstract was made available to Reuters.

"The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity," the experts concluded.

There are three words you never thought you would see strung together....

The study adds to concerns voiced by the same doctors in 2006, after finding that two men had developed low counts of healthy sperm following treatment with two different selective serotonin-reuptake inhibitors (SSRIs).

The article goes on...

Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield, said the apparent increase in sperm DNA damage was "alarming", although he noted the level at which damage becomes clinically significant was open to debate.

"It is a shame that the authors appear not to have conducted a randomised controlled trial which would be the most scientific way to investigate the drugs effects, but I agree that the results are of concern and need to be investigated further," he said.

Drugwonks is open to suggestions for an appropriate study design. 

http://www.reutershealth.com/archive/2008/09/24/eline/links/20080924elin019.html