How about all those Generic Sampling Programs?

• 10.06.2008

Interesting story in today’s New York Times. Here’s how it begins:

"A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children’s health at risk.”

“… do little to help the poor …”   Really? 

No.  According to the report (published today in Pediatrics), once in a doctor’s office, children who do not have health insurance are more likely to receive free drug samples than children with health insurance. And here's the important context part -- children in the lowest income group were no more likely to receive the samples than were those in the highest income group, in part because the poor are less likely to see doctors.

So how do free samples “do little to help the poor?”  Is there some sort of socio-economic biomarker we need to know about?

Skip to next paragraphBut, “… of greater concern, the authors wrote, are the kinds of drug samples that physicians provide.”  Indeed, the issue of pediatric safety is an important one, but all drugs have risks as well as benefits -- and the Precautionary Principle isn't going to help poor kids get better any faster.  But what it will do is create even wider health disparities.   It's also important to note that the report does not conclude that free samples are causing pediatricians to inappropriately prescribe anything. 

According to the Times, “The study’s lead author, Dr. Sarah L. Cutrona, an instructor at HarvardMedicalSchool, said in an interview that the drugs provided as free samples tended to be the newest, so their safety had often not been thoroughly vetted.”

Hey, what about all those generic sampling progams?

The Times interviewed Dr. Andrew Racine, director of general pediatrics at the Children’s Hospital at Montefiore in the Bronx.  He believes that free samples distort doctors’ decision-making. According to Dr. Racine, “This is just a marketing technique.”

Of course sampling is a marketing technique. But does this make sampling deliterious to pediatric health?  That’s the implication (the headline of the story is "Study says Drug Samples May Endanger Children"). 

"Just" a marketing technique?  What about the therapeutic benefits?

Another pediatrician interviewed by the Times, Dr. Lisa Asta of Walnut Creek, CA, said she's considering banning free samples from her practice because the drugs being promoted generally required high co-payments.

This is another important issue – but the answer is not to provide second class care to one cohort of children and a higher quality of care to another.  And banning samples doesn’t make things better -- it exacerbates the problem.

Click here for the complete story in today’s New York Times.

 

Mass Insanity

• 10.06.2008

Last month two Massachusetts scientists won the Albert Lasker Medical Research Award. Commonly called "America's Nobel Prize," the Lasker Award is the country's most prestigious honor for medical breakthroughs. It was given to BayState biologists for their work on gene expression, the results of which show unprecedented promise in the efforts to combat disease.

The win is a testament to the strength of Massachusetts' medical research community. Yet local legislators have recently instituted a law likely to undermine the inter-industry partnerships essential to just this sort of cutting-edge scientific discovery.

In August, Gov. Deval L. Patrick signed a bill requiring pharmaceutical firms to report to state officials any payments over $50 made to physicians, academic scientists, or other medical professionals. The information - including the names of the people getting paid - will be posted on a public Web site. The bill goes into effect Jan. 1, and provides for fines of up to $5,000 for non-compliance.

This disclosure law is supposed to increase transparency. State officials are understandably worried that money from drug makers could unduly influence research results or physicians' practices. And they want to ensure that patients know if their healthcare provider has a financial incentive to recommend certain treatments.

 
But publishing this information suggests that there is something wrong with medical professionals working with the pharmaceutical industry. There isn't.

Physicians rely on drug makers for up-to-date information about new treatments. Drug makers in turn rely on doctors for feedback on the real-world clinical effects of their pills - the kind of information that can't be acquired in a laboratory.

The law is also unnecessary. This summer, the drug industry announced strict new limits on sales personnel, banning them from buying lavish meals or giving gifts of any sort during meetings with physicians. Since physicians are often only available for non-patient work during lunchtime, sales reps will only be allowed to pay for the occasional modest meal at a doctor's office, as long as it's "in conjunction with informational presentations."

And under the new guidelines, sales reps are strictly prohibited from passing along information that is anything other than educational.The BayState's disclosure law will stigmatize the doctors it publicizes. Many might leave Massachusetts in favor of a state with a healthier regulatory environment. That would make a bad situation worse: Nearly a quarter of the state's physicians are already considering leaving or are planning to leave because of legal controls on clinical practices, according to a Massachusetts Medical Society report.

The law will also have a dampening effect on academic medical research.

Funds provided by private firms don't compromise lab work they're essential to getting the research off the ground in the first place. Many of Massachusetts' academic medical centers are currently conducting research in partnership with pharmaceutical companies.Scientists are likely to give up on research projects that require corporate sponsorship for fear of jeopardizing their reputations.

Biopharmaceutical companies employ around 55,000 Massachusetts residents, according to the Center for Labor Market Studies at Northeastern University. If researchers start leaving the state to avoid stigmatization, investment dollars and jobs will follow. And that means fewer breakthrough cures from the commonwealth.

Ironically enough, this law's passage comes at a time when state legislators are making a concerted effort elsewhere to bolster the BayState's medical research industry. In June, Gov. Deval L. Patrick approved a 10-year, $1 billion biotechnology initiative, meant to expand investment in state-level research projects.

This new disclosure law hinders those efforts. It will stifle life science innovation, choke off investment dollars into new cures, and destroy medical sector jobs. Patients, physicians, researchers, and average citizens alike should be outraged.

Mighty Joe Antos

• 10.04.2008

Check out our latest video podcast featuring the brutally honest observations of AEI's Joe Antos.

Check here and then click on the smart looking guy in the maroon-striped tie.

Here's a taste, "We have to stop walling-off reality when it comes to discussing healthcare reform."

Say it ain't so, Joe.

Katie Couric: A Front For Trial Attorneys?

• 10.04.2008

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

Commonwealth Climbs in the Tank For Obama

• 10.04.2008

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.

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.