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.

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.

They’ve got a point. Our $2 trillion healthcare tab is quite steep. But we're not alone — every other developed nation, even those with universal healthcare systems, struggles with high healthcare costs.

Indeed, people in other healthcare systems often pay more than Americans do, once taxes are taken into account. Add in the high non-monetary costs of rationed or denied care and waiting lists, and suddenly the vaunted European systems commonly touted as models for the United States don’t seem like a good deal at all.

Let’s dive into the numbers.

In the US this year, a family of four with an employer-based PPO will face about $15,609 total in healthcare costs. Of this amount, the employer will pay on average $9,442, and the employee will contribute $3,492 in premiums and $2,675 for co-pays and other expenses. Employee premiums are about 6 percent of the median family’s annual income — less than what that family spends on food.

In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians may spend their own money to receive private treatment for procedures or drugs that are not covered by the government system.

Citizens of the United Kingdom pay 11 percent of each pound they make in weekly income between $198 and $1,326 for care through the state-run National Health Service, plus an additional one percent of income over $1,326 per week. That’s nearly double what Americans pay.

The co-pay for drugs is low, but many drugs are not covered, often because they are not considered cost-effective enough to justify inclusion in the government’s plan.

But what if you need one of those drugs? Well, you can kiss your NHS benefits good-bye. Anyone who uses his or her own money to buy drugs outside the NHS will find him or herself shut out of the system.

In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. This coming fall, premiums are set to be standardized — and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.

In France, employees contribute only 0.75 percent of their salaries towards medical care, but they also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the bulk of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, which costs approximately 2.5 percent of salary.

When compared to the U.S., the fact is that the health care systems in Europe and Canada don’t save citizens much at all.

Health reform is urgently needed in this country, and cost-cutting will be a critical component of any reform efforts. Despite its supporters’ claims to the contrary, government control of the healthcare marketplace is anything but a ticket to a lower-cost healthcare paradise.

Starting next year, Eli Lilly and Co. will reveal how much money it pays physicians for speeches and consulting. According to a report in the Indianapolis Star, Lilly president and chairman, John Lechleiter, will announce the new policy in an address to the Economic Club of Indiana today.

"Lilly is striving to be a leader in improving transparency across our industry," Lechleiter said in a statement. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Under Lilly's registry of physician payments, they will list fees to physicians who serve the company as speakers and advisers. That information, which likely will include physicians' names and hometowns, will be posted starting in the second half of 2009 on a publicly accessible Internet database, Lilly said.

In 2011, Lilly plans to expand the database to include payments, updated annually, for clinical research and other provisions called for in the Physician Payments Sunshine Act pending in Congress.

For a big drug company to be the first to disclose its payments to doctors "takes a lot of courage," said Sen. Herbert Kohl, D-Wis., a co-sponsor with U.S. Sen. Charles Grassley, R-Iowa, of the Sunshine Act.

In 2004, Lilly became the first drug maker to voluntarily make public data on its clinical trials of new drugs. Last year it began publicly reporting its educational grants and charitable contributions, becoming the first in its industry to do so.

Now maybe people will start listenng.

Both campaigns, it seems, have come to their senses. The issue is safety.

And:

(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

The important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”

(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.

And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.

(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.

The next canard, that of "universal" care is even more dangerous. It's government care -- and it ain't free.

"Universal" care is the new importation.

But we'll bask in the demise of importation until Monday.

(And, hopefully, reports of its death have not been greatly exaggerated.)

Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.

But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right. The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.

But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”

That’s not true. It’s not fair. And it’s not helpful.

40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.

That’s great news. But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.

It's a good problem to have.

CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.

1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.

Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.

But it’s not all rosy and it’s not as easy as reporting numbers.

The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.

All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.

In keeping with that metaphor, comes news that Germany’s IQWiG (the Institute for Quality and Efficiency in Healthcare) is preparing to test a new cost-benefit methodology towards the end of this month. The test will last for about four months.

To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year and drew many comments (not all laudatory) from stakeholders. Some were critical of the proposed "efficiency frontier analysis" the institute plans to use as the basis of cost-benefit assessments. IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives.”

“Flexible” is in the eyes of the beholder.

IQWiG´s new methodology will help determine an “appropriate ceiling” price for drugs that are reimbursed by the statutory health insurers but cannot be included in a reference price group. IQWiG’s assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the health care system as a whole.

The cross-channel (and potential cross-Atlantic) implications are especially timely coming on the heels of the Baucus/Conrad bill and while experts are predicting a meltdown of Britain’s NHS.

The answer? According to Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), draconian rationing. As he said earlier this week, "Rationing is a necessary evil. We have to do it. There will be losers and winners." That's "universal" health care in its true guise of cost-based "government" health care.

As Tom Lehrer sang, “Once the rocket goes up who cares where it comes down. That’s not my department says Wernher von Braun.”

But where are the front page stories? Where's the outrage?

Where's the justice?

Here's the complete editorial:

Debunking an Autism Theory

Ten years ago, a clinical research paper triggered widespread and persistent fears that a combined vaccine that prevents measles, mumps and rubella — the so-called MMR vaccine — causes autism in young children. That theory has been soundly refuted by a variety of other research over the years, and now a new study that tried to replicate the original study has provided further evidence that it was a false alarm.

The initial paper, published in The Lancet, the prestigious British medical journal, drew an inferential link between the vaccine, the gastrointestinal problems found in many autistic children and autism. In later papers, researchers theorized that the measles part of the vaccine caused inflammation in the gastrointestinal tract that allowed toxins to enter the body and damage the central nervous system, causing autism.

Now, a team of researchers from Columbia University, Massachusetts General Hospital and the Centers for Disease Control and Prevention has tried and failed to replicate the earlier findings.

These researchers studied a group of 38 children with gastrointestinal problems, of whom 25 were autistic and 13 were not. All had received the vaccine for measles, mumps and rubella. The scientists found no evidence that it had caused harm. Only 5 of the 25 autistic children had been vaccinated before they developed gastrointestinal problems — and subsequently autism. Genetic tests found remnants of the measles virus in only two children, one of whom was autistic, the other not.

The new study adds weight to a growing body of epidemiological studies and reviews that have debunked the notion that childhood vaccines cause autism. The Institute of Medicine of the National Academy of Sciences, the C.D.C. and the World Health Organization have found no evidence of a causal link between vaccines and autism.

Meanwhile, the original paper’s publisher — The Lancet — complained in 2004 that the lead author had concealed a conflict of interest. Ten of his co-authors retracted the paper’s implication that the vaccine might be linked to autism. Three of the authors are now defending themselves before a fitness-to-practice panel in London on charges related to their autism research.

Sadly, even after all of this, many parents of autistic children still blame the vaccine. The big losers in this debate are the children who are not being vaccinated because of parental fears and are at risk of contracting serious — sometimes fatal — diseases.

By plotting the differences between genetic variations of 3,000 Europeans in a two-dimensional grid, the researchers were able to reveal a pattern that looks remarkably like Europe. The scientists included researchers from CornellUniversity; the University of California, Los Angeles (UCLA); the University of Chicago; and the University of Lausanne, in Switzerland. The findings appear in this week's issue of Nature.

Fortunately the Critical Path does not require a visa -- but it does require funding -- now!

Reuters reports that, “Expensive advertising of prescription drugs directly to consumers may do little to encourage sales, U.S. and Canadian researchers reported on Monday.”

According to the report, even though companies spent an estimated $3 billion in 2005 on such ads in the United States, they did not appear to result in more prescriptions.

"People tend to think that if direct-to-consumer advertising wasn't effective, pharma wouldn't be doing it," HarvardMedicalSchool's Stephen Soumerai said in a statement. "But as it turns out, decisions to market directly to consumers are based on scant data."

The nonprofit Kaiser Family Foundation has come to similar conclusions in reports on direct-to-consumer ads.

In an April report the foundation found that 91 percent of adults surveyed had seen or heard advertisements for prescription drugs, but just one-third spoke to a doctor about a drug they saw advertised, and 54 percent of them got a prescription for a different drug.

Among doctors, 76 percent said they sometimes recommend a different prescription drug to a patient who mentions a drug ad and 5 percent said they frequently gave patients the drug.

Here's a new article from The Scotsman:

Advertising rules stifle free market for prescriptions
By Peter Pitts

IN EUROPE, it is illegal for drug companies to advertise prescription-only drugs to consumers. But the European Commission (EC) recently announced that it will allow pharmaceutical firms to disseminate "information" on their products over the airwaves, on the internet, and in print.

I think this change can't come soon enough. For too long, European bureaucrats have put cost considerations before patient care, keeping patients in the dark about alternatives that may best address their needs. Officials have, I think, paid lip service to the idea of empowering patients with more information on treatment options.

James Copping, a principal administrator of the EC, said in 2006: "We want a system where patients can be empowered to take an equal part in healthcare decisions." But thus far, no such thing has happened.

Consider the European agencies tasked with weighing the effectiveness of various treatments, such as the UK's National Institute for Clinical Excellence (Nice) or Germany's IQWiG. These agencies exist to provide unbiased medical information to government.

But because they are operated by government, I would say they have a vested interest in keeping costs down and have an incentive to conclude that newer, more expensive medicines are no more effective than older, cheaper ones.

Nice offers an instructive example. In 2001, contrary to expert findings by licensing authorities in 65 countries – including Scotland – it cited "insufficient evidence" for recommending the use of Gleevec in leukaemia patients.

In 2002, US authorities approved Gleevec for the treatment of stomach cancer and it was deemed a miracle drug. It wasn't until 21 months later that Nice authorised the use of Gleevec for English victims of the disease.

IQWiG seems similarly set on depriving German patients of vital treatments. The agency has promoted an "efficiency frontier" as its governing methodology for evaluating treatments. But such jargon is smoke and mirrors, designed to cover for the government's preference for established – and generally less expensive – treatments, and by decreeing the most cost-effective option in a treatment category, these agencies effectively determine what a doctor must prescribe, irrespective of a patient's individual characteristics.

Obviously, pharmaceutical companies have products to sell. But, by allowing them to provide Europeans with medical information, they could serve as a counterbalance to the heavy-handed pronunciations of state-run comparative-effectiveness agencies.

Indeed, a great deal of evidence demonstrates that consumers benefit when drug manufacturers participate in healthcare decision-making.

In the US, for example, a 2002 study by the Food and Drug Administration found that direct-to-consumer advertising of pharmaceuticals improved both patient-doctor discussions and compliance with physician recommendations. The study also found that 88 per cent of patients who asked about a specific drug were afflicted with the condition in question.

A 2003 study in US health policy journal Health Affairs arrived at a similar conclusion. According to the study, ad- inspired doctor visits resulted in the advertised medicine being prescribed in only about 47 per cent of cases. Put another way, patients didn't get a prescription for the medicine they came in to discuss on more than half their visits. Even with advertising, doctors exert appropriate judgment when they prescribe drugs.

On other occasions, according to the study, previously undiagnosed medical conditions get treated – a good thing.

For European bureaucrats, there is reason for concern. If consumers can get additional information on drug options thanks to direct-to-consumer efforts, there's a good chance they'll start to ask the state-run health systems why they can't access certain treatments.

As European Parliament member Jorgo Chatzimarkakis recently argued: "Citizens cannot be deprived of information by their own governments on such crucial issues as one's health."

Government-run systems have demonstrated that they're not interested in spending more money, but armed with new information, consumers may be able to make the case to their leaders that the status quo of rationed, controlled care will no longer suffice.

A recent report published in The Lancet was the first international analysis of cancer survival that provides comparable data across countries. Across all cancers studied, survival in the US was greater than in Europe. For example, 5-year relative survival for women with breast cancer was 84% in the US and 73% in the EU. For men with colon cancer in the US survival was 60% whereas in the EU it was 47%.

The researchers attributed the variation in survival to “differences in access to diagnostic and treatment services.”

Similarly,

Is the conventional wisdom that medicines for the very ill are healthcare budget busters? Not when you consider the facts.

A recent study published in Health Affairs found that for the severely ill, commercially-insured population, the costs of medical services account for more than 75% of health plan costs. Hospitalization costs accounted for half of this amount. In contrast, medications accounted for just over 20% of health spending for this group, whose annual costs are more than nine times higher than the overall plan population. The authors concluded that medication costs “do not seem to be the driver of health care costs for these members.”

Among the 2.5% of members with the highest spending, specialty medicines (defined in this study as "biologic-derived agents that target specific immune processes and proteins”) were used by 45% and accounted for 32% of spending on medicines and just 6.6% of total plan spending.

Pharma is not the enemy – disease is the enemy.

(But that’s not a convenient political sound-bite.)

Let’s not forget the wise words of Aldous Huxley, “Facts do not cease to exist because they are ignored.”

First let’s talk about transparency.

As John Jenkins (aka, “Dr. Wry”) appropriately pointed out, communications the agency has with sponsors is commercial confidential. That’s the law. The agency’s hands are tied. Period.

Why? Many reasons, but the most important is, well, commercial confidentiality. Trade secrets. Intellectual property. And when it comes to drug development, that’s core business, intelligence other companies would love to see.

But they can’t. And that’s appropriate. It’s at the very heart of a market-based system. The system that has driven unprecedented advances in pharmaceutical development.

The alternative, the so-called “patent-free” idea advocated by Jamie Love and Senator Bernie Sanders (aka, “the Senator from Ben & Jerry’s") was last applied in the former Soviet Union -- and it didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.

Intellectual property rights are the fertile soil that facilitates the tree of pharmaceutical innovation to grow in the first place. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. That's a Silent Spring we cannot afford.

The question of honesty, however, is a more difficult issue. “Difficult” because honesty is often in the eyes of the beholder.

If you’re a journalist or pundit, you want as much information as possible. If (post August 11th 2008) the FDA issues a “complete response” letter, you want to see it so you can fully understand and report on the issue. If you’re the sponsor, you don’t want to share it because of both intellectual property considerations – but also because of how the contents of the communication might impact (among other things) how Wall Street views the value of your stock.

Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known. And let’s face it, that can quickly slip/slide into spin. Is not telling the whole truth a lie? It depends on which side of the information divide you reside. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. But one rule is crystal clear – misleading information is just plain wrong.

It’s a fine line.

And speaking of honesty, the news out of Parklawn/White Oak is that 2008 is likely to be one of the slowest years for new drug approvals in the last five years.

Some in Big Pharma (and small pharma and biopharma) blame this on the FDA’s renewed “obsession with safety.” But how can the FDA take action on applications it hasn’t received? The real question is whether or not the FDA has helped or hindered new applications.

Going down this path leads to a discussion of the importance of the Critical Path. And, unfortunately, at present that’s more of a political conversation. Hello Ms. DeLauro. FDA can (indeed must!) be a facilitator – but the main responsibility for 21st century drug development resides with innovator companies.

And hence the importance of intellectual property protection and the need for (yep, you guessed it) commercial confidentiality.

What goes around comes around.

Is this the end of the dynamic duo of safety/efficacy and the beginning of a new Holy Trinity that includes comparative effectiveness?

Most reporting went something like this (courtesy of the Washington Post):

“Vanda Pharmaceuticals' stock tumbled 73 percent Monday after federal regulators rejected the Rockville biotech's schizophrenia treatment, saying it was similar to a drug already on the market.” (My italics.)

In fairness, the FDA didn’t actually say anything. This is how Vanda chose to represent the communications it received from the agency.

But rather than looking at this through the lens of comparative effectiveness – perhaps a better way to think about it is via comparative safety. Should inferior performance in some settings (for example if you won't know about it for weeks) be a molecule killer? The debate isn’t only (or primarily) whether it's bad to be worse – but also whether it can be easily monitored.

A tough situation for the FDA and a potential opportunity for those who would exploit this situation to call for a NICE-like system in the U.S. – such as Senators Baucus and Conrad and their “Comparative Effectiveness Research Act of 2008”

But it’s really just the latest example of why dogmatic approaches to drug regulation don’t work -- and why the Critical Path program is so essential.

Nobody said the FDA’s job was an easy one.