Latest Drugwonks' Blog

It seems that Sarah Palin isn't the only target for Katie Couric and CBS News...

In recent years Katie and her crew have gone after vaccine makers and the make believe link between vaccines and autism, taking up the cause of trial attorneys on the one hand and glossing over the scientific data demonstrating no relationship on the other...

Back in June 2007, “CBS Evening News” featured a story titled “Vaccines suspected in rise in autism rates.” CBS News correspondent Sharyl Attkisson reported on the hardships of the parents of an autistic child and their fight to win money from a federal fund for “vaccine damages.”

“Twelve-year-old Michelle Cedillo doesn't know it, but she's the center of a landmark case that started today in federal vaccine court, one that could open the door for thousands of autistic children to be paid by a government fund,” Attkisson said on the June 11, 2007, “CBS Evening News.” “The controversy: whether their autism was caused by their childhood shots.”

Seven months later, the study, supported through the California Department of Public Health according to a press release, got little fanfare. It got only a brief mention on “CBS Evening News,” despite CBS airing six stories over the past two-and-a-half years that sounded alarm bells over thimerosal, according to a Nexis search.

One CBS story, aired on July 15, 2005, included the ranting and ravings of environmental extremist Robert F. Kennedy, Jr. “The science connecting brain damage with thimerosal is absolutely overwhelming,” Kennedy said.

See here.

In June of 2008, Attkisson was at it again, this time trying to discredit scientists and organizations who support immunization because they receive support from vaccine companies (ignoring the fact that Robert F Kennedy and others she provided fawning coverage for are on the trial attorney take...) Here's the lead into a story on Katie's show one month after the California study came out:

"For years some parents and scientists have raised concerns about vaccine safety, including a possible link to autism and ADD. Many independent experts have sided with government officials and other scientists who say there's no possible connection. But how "independent" are they? "

http://www.cbsnews.com/stories/2008/07/25/cbsnews_investigates/main4296175.shtml

Now it turns out that Katie is bringing another reporter into her stable with close ties to trial attorneys whose history is writing about health litigation issues – principally sourced from class action litigators, Heather Won Tesoriero.

Heather Won Tesoriero is brand new to CBS and this is probably working now on her very first stories. At the beginning of September she joined a leading talent agency ( N.S. Bienstock) which helped her move from medical and law reporter at the Wall Street Journal to CBS NEWS as a field producer covering medical issues. It appears she’s trying to make a big leap and name for herself with Katie Couric. Will CBS and Couric become the latest platform for Tesoriero’s history of big class action law firm-sourced attacks? If Atkisson's autism crusade is any indication what's to come, the answer is yes.

While a WSJ staff health reporter and blogger she primarily focused on medical-related fraud/litigation issues and is clearly well-connected to the plaintiff’s attorneys side quoting their claims and interviewing them unchallenged on WSJ-TV. She was “co-counsel” for the WSJ Law Blog. She’s done several reports on drug side effects (clearly promoted by class action litigators), some environmental-linked health claims and other purported health fraud topics. No one should be surprised if she brings the same sources, bias and unbalanced reporting to CBS.

Links to other related stories written by Tesoriero on behalf of class action litigators:

· Oil Firms Settle Claims In MTBE Leak Cases – article

· Video interview with plaintiff attorney by Tesoriero on MTBE leak

· Patients Sue Icelandic Drugmaker Over Recalled Heart Drug

· Health-Care Fraud: Keep an Eye on the Small Fry

· Wayward Medical Records Sold as Scrap Paper for $20

· Whistleblower Law Blog: Tesoriero and quitam lawsuit

· Vioxx Study Casts Doubt on Merck Claim


Only a small margin of voters believe that Obama's health plan will benefit them personally compared to McCain's plan.

See here.

So along comes the supposedly non partisan Commonwealth Fund with a report claiming that the Obama plan will do a better job in reducing the number of people without health insurance.

See here.

Unfortunately media reports ignore the fact that the Commonwealth Fund also produced a study this past summer "demonstrating" that something like the Obama plan would only cost $165 billion over ten years and touted the features of the Obama plan including a National Health Exchange, expanding Medicaid, subsidies for large corporations, etc.

See here.

Nothing like using the media to pass on a favorable review of your own proposal and as a springboard to jump into the tank with Obama.

Fake Drugs ToGo

  • 10.03.2008

From the New York Times:

Belgium: Shipments of Fake Pills Seized

Customs officers at the Brussels airport seized more than two million counterfeit pills on Thursday that were made in India and destined for Africa, officials said. Blister packs of the pills, above, which included counterfeits of Tramal, a painkiller, and of Fansidar, an antimalaria drug, were found in large bags, the customs service said in a statement. The pills were sent in three shipments by a company based in Mumbai and were bound for two companies in western Africa. Lieven Muylaert, spokesman for the Belgian customs department, told Agence France-Presse, “To our knowledge, this is the biggest seizure of counterfeit medicine ever carried out in Europe.”

From the BBC:

Belgians seize Africa-bound drugs

More than two million counterfeit drugs destined for Africa have been seized in Belgium, customs officials say.

They said the shipment from India, including copies of an anti-malaria drug, was the biggest seizure of fake medication ever made in Europe.

Customs officers at Brussels airport became suspicious when they noticed spelling mistakes on the labels.

 The UN says fake medicines represent 10% of the world market and up to 30% of the African market.

The seizure, made last week, was made public on Thursday night.

Hidden in large bags, the pills were copies of a strong painkiller made by a German company, and a Swiss-made anti-malarial treatment.

The confiscated medicines had been sent in three shipments by an Indian company in Mumbai, and were bound for two unnamed companies based in Togo.

Belgium's Le Soir newspaper reported that the drugs were probably intended to be distributed across West Africa.

"Thanks to this seizure, we have saved lives," Le Soir quoted Lieven Muylaert, spokesman for Belgium's customs department, as saying.

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.

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"

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

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

The National Consumers League released a survey of 1,035 prescription drug users on therapeutic substitution issues this morning.  The survey was conducted by Harris Interactive.  Full results and additional materials are online at www.nclnet.org/health/switching/ and the press release is at http://www.nclnet.org/news/2008/therapeutic_substitution_10012008.htm.     

 Key data points include:

Patients Surveyed Want Transparency about Therapeutic Switching

  • Respondents very much oppose health insurance companies providing incentives to pharmacists (55%) or physicians (55%) for switching patients to lower cost alternatives to medications.
  • Vast majorities of respondents (78%) very much favor an explicit requirement to consult the physician before any and all therapeutic substitution takes place.
  • Vast majorities of respondents (85%) very much favor a requirement that patients always be notified if their prescription is changed.
  • A large majority of the general population are not sure if there is a law in their state that regulates therapeutic substitution (90% of the Rx users), but 50% of Rx users somewhat or very much favor legislation. 


Patient Awareness of Therapeutic Switching is Low, but Patients Believe it is Happening

  • As expected, awareness of the concept of therapeutic substitution – and the difference with generic substitution – is low.

        2 of 3 prescription users are unaware therapeutic substitution

        Only 1 in 4 prescription users are unaware that therapeutic substitution involves replacing the prescribed drug with a chemically different one

  • The vast majority of Rx users think that therapeutic substitution occurs at least sometimes in the US (84%), without informing the patient (68%) or the prescribing physician (59%).

Switching Doesn’t Always Result in Positive Outcomes

  • 15% of general Rx users saying that they or a family member experienced therapeutic substitution

        Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.

        More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.

        Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.

For more information including a fact sheet and full summary from Harris, please visit these sites:

- NCL Home page: http://www.nclnet.org/

- NCL Supporting materials: http://www.nclnet.org/health/switching/

- Full Harris summary is also online: http://www.nclnet.org/health/therapeutic_substitution.pdf

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.

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.

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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