October 06, 2008

Mass Hysteria

by Peter Pitts

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.

Posted by peterpitts at 12:32 PM
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October 03, 2008

European Commission Calls for More Healthcare Cowbell

by Peter Pitts

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.

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September 29, 2008

Who Spends What on Healthcare?

by Peter Pitts

On both sides of the aisle, politicians repeatedly criticize the amount of money America spends on health care.

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.

Posted by peterpitts at 08:16 AM
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September 17, 2008

Caste of Characters

by Peter Pitts

The House Energy & Commerce Committee needs to help fix the problem, not the blame.

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.

Posted by peterpitts at 08:12 AM
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September 12, 2008

IQWiG Aims at the Stars

by Peter Pitts

“I Aim at the Stars,” was a 1960 B-movie biopic about Wernher von Braun. Many felt that it should have been subtitled, “But sometimes I hit London.”

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.”

Posted by peterpitts at 08:26 AM
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September 09, 2008

The shot not heard 'round the world

by Peter Pitts

Today the NY Times, in a house editorial, tells the truth about vaccines and autism.

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.

Posted by peterpitts at 10:01 AM
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September 05, 2008

If it’s Tuesday it must be a single nucleotide polymorphism

by Peter Pitts

Scientists have shown that they can use genomic analysis to pinpoint a person's geographical origins to within just a few hundred kilometers. Besides offering possibilities for the testing of genetic ancestry, the research could also have important implications for understanding the role of genes in complex diseases and other genomic-based health studies.

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!

Posted by peterpitts at 09:31 AM
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August 20, 2008

Brave New Healthcare World

by Peter Pitts

Does it seem counter-intuitive that “universal” care results in restricted access and poor outcomes? Not when you consider the facts.

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.”

Posted by peterpitts at 11:42 AM
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August 06, 2008

Dogmatic Day Afternoon

by Peter Pitts

Much hand wringing and speculation over the FDA’s recent Vanda decision. And the big question being asked is:

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.

Posted by peterpitts at 10:12 AM
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July 28, 2008

Doctor -- reveal thyself

by Peter Pitts

The other day I attended a seminar (sponsored by Pfizer) at the New York Academy of Sciences. (40th floor at 250 Greenwich Street -- what a view!)

But the views offered on the inside were equally stimulating.

A few examples:

Elizabeth Teisberg (Professor, Darden School of Business, University of Virginia):

"Today pay-for-performance" means "pay-for-process-compliance."

Dr. J. Edward Hill (Past President, American Medical Association):

"If we believe in evidence-based medicine, then we should consider the evidence of what government run healthcare provides."

Dr. Hill also posed this interesting question, "Can we really have personalized care provided by the government?"

Dr. Michael McGinnis (Senior Scholar, Institute of Medicine):

"40% of deaths in the US are caused by the behavioral choices we make," led by lack of diet, not enough exercise -- and tobacco.

He also pointed out that "what happens at the intersections of the domains of influence" is what drives both health and care. McGinnis defined the relevant "domains of influence" as Behavioral, Genetic, Social, Environmental, and Healthcare.

There was much heated debate and audience participation -- but the most memorable comment was also one of the pithiest and it came from Dr. Hill who said, "People need to quit being complacent."

And included on that list of people needs to be doctors.

(Yes, doctors are people too.)

I asked Dr. Hill why we only hear from doctors when it's about their payment schedules. His reply was honest -- "I was afraid someone was going to ask me that question."

And that's when he offered the remark about complacency.

Posted by peterpitts at 08:58 AM
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July 18, 2008

CCHIT Happens

by Peter Pitts

From the pen of Secretary of Health and Human Services Mike Leavitt:

Commission’s rigorous testing helps ensure interoperability of technology

As Congress takes up the subject of health information technology, it must take great care to enable accelerated progress rather than sending the process back to the starting line.

My vision of health information technology in the United States is a world where medical information can be privacy-protected and managed in a way that produces better quality, lower costs, fewer medical mistakes and less hassle for everybody. Building such a system requires that clinics, hospitals, pharmacies, labs and patients have systems that speak the same language — that are “interoperable.”

Getting health information systems in various parts of the healthcare system to work together requires the adoption of common technical standards. I’ve often compared the problem to the building of railroads. Before the railroads of the East, West, North and South could be interoperable, they all had to agree on one standard track size. A similar process is required with health IT, except that the degree of difficulty is much harder than just agreeing on a track size.

There are more than 200 developers of electronic medical record systems in the United States.

Until three years ago, there was no process for harmonizing and coordinating the standards they used. To remedy this problem, we formed the American Health Information Community (AHIC). It has succeeded, and as time passes we are seeing an accelerating stream of solid and widely accepted health IT standards emerge.

People who buy systems need to know they are making an investment that will connect them with the rest of the medical world. Today, they can buy with confidence.

The Certification Commission for Healthcare Information Technology gives systems a rigorous testing to demonstrate interoperability. Those systems that pass the test are given CCHIT certification. When doctors buy systems with that seal, they know that they are on a pathway to interoperability. This has given many doctors the confidence to buy who were waiting before.

We have seen more progress toward interoperability in the past three years than in the previous two decades. This is because government agencies, the medical family, the insurance industry and the health IT sector are all working together collaboratively. This type of collaboration is hard and requires great effort, but it is working, and its momentum is increasing.

As Congress begins to write a health IT bill, it is critical that it be crafted in a way that does not interrupt this success by imposing government controls. Government has to be at the table as a full participant, but if the bill prescribes the way these standards are to be set, or puts in place a politically controlled process that picks winners and losers, it will devastate a healthy but fragile process and lose three years of maturity and momentum.

I would offer three principles to members of Congress in dealing with legislation:

First, let’s protect the flexibility of those who are working to invent new tools, and let’s not undermine the work on AHIC that is already underway. Writing legislation to bias the process in one direction or another will constrict innovation and slow the process.

Second, let’s not try to solve all the privacy challenges of the 21st century in a health IT bill. We have to be careful to avoid penalizing early adoption.

Third, let’s respect the need for legitimate healthcare communications. We have to find the balance here. It is in the patient’s best interest for doctors and the patient to have information.

The most important thing government can do is adopt the standards ourselves. The adoption of standards by Medicare, the Veterans Administration, the Department of Defense, and Indian Health, is critical.

We’re making progress on health information technology. Let’s make sure that any legislation accelerates the progress already under way, rather than chilling it with requirements that the government dictate one-size-fits-all answers.

Posted by peterpitts at 08:04 AM
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June 10, 2008

Money talks? Healthcare walks.

by Peter Pitts

Last week I attended a conference of European pharmaceutical executives, legislators, and regulatory officials. The theme was “Economics and Ethics.”

While the “universal” consensus was that ethics are primary – economics came in a very close second. One robustly debated theme was the idea of “an ethical standard based on resources.”

In other words, reality.

We live in the real world where increasing drug development costs and shrinking resources for reimbursement (government-paid in the case of the Europeans) cannot be ignored when it comes to either green-lighting a development program or making an access decision based on healthcare technology assessment (HTA).

One leading consultant suggested that pharmaceutical development program should not proceed beyond Phase II until the company met with reimbursement agencies to gauge the likelihood of a positive coverage decision based on clinical endpoints.

Frightening that such a highly paid consultant could so completely miss the point – that government healthcare systems exist to serve their citizens, not to act as actuarial bean counters. Financial prudence? Cetainly. But not at the expense of the right medicine for the right patient at the right time. That’s a medical decision. That’s ethics.

Many present pointed out that what we really need are better tools to allow smarter development programs that don’t fail in late Phase III (as over 50% do today). In the US that means the Critical Path. In Europe it’s the Innovative Medicines Initiative. Both are predicated on patient-centric care.

But when a healthcare system is a government-pay model, the cost-based versus patient-centric momentum seems unstoppable.

Consider the remarks last week of Thomas Lonngren, executive director of the European Medicines Agency (EMEA),

"It could come to a situation where we are approving a product based on efficacy, safety and quality ... but the patient can't get it because the health technology institute says it is not cost-effective."

Note to Tom – already happening.

Consider Britain's National Institute for Health and Clinical Excellence (NICE) and the series of high-profile disputes in which new drugs for conditions such as cancer and rheumatoid arthritis have been turned down for use on the state health service.

And what’s worse than a bad decision in one country? Correct – a cavalcade of uncoordinated, voodoo cost-based decisions -- with one even less patient-centric than the last. Or, as Lonngren commented,

"… a different decision in each member state (of the European Union) because this is not harmonized.”

Other countries, including Germany, have recently set up their own versions of NICE and
Lonngren said the emergence of such health technology institutes posed a challenge for drug manufacturers since these bodies often required additional research, and he suggested there might be scope for cooperation with the EMEA in designing drug approval programs in future.

Is that a good idea, EU harmonization of HTA? Or is it the camel getting its nose under the tent?

And that, dear readers, is the distinction between “universal” healthcare and “government” healthcare. In short –no difference at all.

Posted by peterpitts at 08:49 AM
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May 28, 2008

Punxsutawney Pill

by Peter Pitts

Interesting story in the New York Times about a company that's producing placebos for kids.

According to the article: "Jennifer Buettner was taking care of her young niece when the idea struck her. The child had a nagging case of hypochondria, and Ms. Buettner’s mother-in-law, a nurse, instructed her to give the girl a Motrin tablet. She told me it was the most benign thing I could give, Ms. Buettner said. I thought, why give her any drug? Why not give her a placebo?

Studies have repeatedly shown that placebos can produce improvements for many problems like depression, pain and high blood pressure, and Ms. Buettner reasoned that she could harness the placebo effect to help her niece. She sent her husband to the drugstore to buy placebo pills. When he came back empty handed, she said, It was one of those ‘aha!’ moments when everything just clicks.

With the help of her husband, Dennis, she founded a placebo company, and, without a hint of irony, named it Efficacy Brands. Its chewable, cherry-flavored dextrose tablets, Obecalp, for placebo spelled backward, goes on sale on June 1 at the Efficacy Brands Web site. Bottles of 50 tablets will sell for $5.95. The Buettners have plans for a liquid version, too."

Sounds good? Maybe not. Consider the comments of Dr. Howard Brody, a medical ethicist and family physician at the University of Texas Medical Branch at Galveston. “Placebos are unpredictable. Each and every time you give a placebo you see a dramatic response among some people and no response in others.”

“The idea that we can use a placebo as a general treatment method,” Dr. Brody said, “strikes me as inappropriate.”

Here’s a link to the complete article:

http://www.nytimes.com/2008/05/27/health/27plac.html?_r=1sq=placebo%20pill%20for%20children&st=nyt&adxnnl=1&oref=slogin&scp=1&adxnnlx=1211983244-SHLqYEyzaft9yv7JxPWWrw

And here’s my take – will products like Obecap teach children that there’s a pill for every problem? Is that a health care message that we want to teach our children? It also reinforces the general mindset that leads to parents demanding antibiotics for ear-aches. Not the way to go. We need to teach our children wellness.

Posted by peterpitts at 02:11 PM
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May 06, 2008

Value vs. Volume

by Peter Pitts

Last Thursday, in Chicago, HHS Secretary Mike Leavitt kicked off the 28th annual Midwest Business Group on Health conference (smartly themed “Survivor: Health Benefits Island”). He made some interesting points:

The first is that we need to redesign our healthcare system so that we reward “value rather than volume.” No argument there. It’s also very much in keeping with what Senator McCain is talking about these days.

He then turned his attention to the HHS “efficiency roadmap.” Lots of good initiatives. (I know, there are always a lot of “good initiatives.”) What was missing, however, was how to overcome one of the most significant roadblocks – state lines. Specifically, in addressing a group made up of large employers, the Secretary didn’t discuss insurance deregulation as a strategy towards more affordable, accessible, and patient-centered coverage. This must be a key strategy in the “value vs. volume” proposition.

He spent the lion’s share of his remarks (and productively so) talking about the need for inter-operability of healthcare IT platforms – where HHS has helped to both design and implement some successful programs lead the still nascent national dialogue.

One comment he made is worth repeating for both its wit and honesty. Leavitt quipped that “the wonderful thing about healthcare standards is that there are so many to choose from.”

And may we all live in interesting times.

Posted by peterpitts at 07:39 AM
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April 29, 2008

Follow-on O Ship of State

by Peter Pitts

Excellent piece by Bryan Liang in the Los Angeles Times:

Don’t Compromise the Safety of Biotech Drugs

By Bryan A. Liang
April 28, 2008

A toy plane has a handful of parts. A Boeing 747 has several million. This makes sense. Toy planes are small, simple models, while 747s are large, high-performance aircraft that travel more than 500 mph with thousands of component systems acting together. The model costs a few dollars because it's easy to manufacture. The 747 costs about $225 million because of its highly complex nature, testing and the need to ensure safety.
The comparison is worth keeping in mind as the debate heats up over "follow-on" biologics. Biologics are today's most advanced medicines, fully tested biotechnology protein drugs that provide targeted therapy to victims of cancer and other diseases. Follow-on biologics are the second or subsequent versions, but they are not identical.

U.S. spending on them reflects the importance of these drugs in medicine's arsenal. Biologics represent the fasting-growing sector in the medicines market, with more than $30 billion spent on these drugs each year. Indeed, the top five drugs in terms of Medicare expenditures administered in physicians' offices are biologics. By 2010, worldwide spending on biologics is estimated to grow to $10 billion, and biologics will make up nearly half of all newly approved medicines. Hence, many policymakers are focused on reducing the costs associated with these drugs.

Congressional legislation is pending that would allow the sale of follow-on biologics without requiring extensive testing -- essentially following the same model used for approval of generic forms of traditional prescription drugs.

But most drugs we're familiar with, like the pills we get from the pharmacy, are "small-molecule" drugs -- simple chemical compounds. They can be easily manufactured and identically copied. The anti-convulsant drug valproic acid, for example, has a total of just 26 atoms.

Identical to the brand-name version, these generics can "piggyback" on a brand-name company's testing. That's reasonable. These small-molecule drugs -- which typically are made up of a total of 20 to 100 atoms -- can be copied perfectly. So they don't need independent safety testing, cost less to make and are cheaper -- allowing more patients to obtain the medical benefits.

But biologics are far more complex. The brand-name drug Herceptin, a biologic that's widely used to treat cancer, is made up of a total of roughly 25,000 atoms. Large biologics can have millions of atoms.

Biologics aren't made by combining chemicals in a flask. They're made by life forms such as cells, yeast and bacteria. Like humans, these life forms exhibit diversity in metabolism and composition, making the final product a unique, heterogeneous mix that cannot be copied exactly. So follow-on biologic forms of a drug can only be similar to the original, not identical.

Because of the complexity of biologics, there's more regulation. In comparison with common chemical drugs that can have generic versions -- such as penicillin -- which only require 50 to 60 manufacturing tests for safety and quality, biologics require at least four times that number.

So the policy challenge is to provide incentives for innovation while also ensuring that any follow-on forms of biologics that enter the market are safe.

The key lies in something called "data exclusivity," which is a legal mechanism for allowing a company to keep confidential the data associated with a drug's development. Data exclusivity usually lasts for several years and spurs innovation by protecting new inventions. This is the current rule for small-molecule drugs, and it should be applied to biologics as well. Strong data exclusivity is critical for biologics, which are about 50% more expensive to develop than small-molecule medicines.

However, the current state of science makes ensuring safety of follow-on biologics difficult. Currently, the technology to map out the exact chemical structure and function of one large biologic versus another is not available. That makes safety reviews inexact. And follow-on forms may induce unpredictable adverse reactions.

Several years ago, a fully tested biologic created in the U.S. was cooperatively licensed overseas to be made in Europe. But the new version caused patients to suffer "pure red cell aplasia," whereby their bodies could not make red blood cells. This may have contributed to the deaths of some patients and permanent injury to others. Yet today, after eight years of research, the cause of these reactions is still unknown.

If even cooperative company efforts can result in unpredictable adverse reactions, any follow-on product that does not undergo full testing should be of concern. Recognizing this reality, the European Union has developed a system of assessment that requires clinical testing of follow-on products in Europe before approval.

U.S. policymakers should take note. Relevant clinical data and testing should be required to ensure safety of any follow-on biologic product being considered for patient use in the U.S. And appropriate data exclusivity should be put in place to foster innovation.

If chemical drugs were toy planes, biologics would be 747s, the cutting edge of medicine. Because of their complexity, any follow-on forms must be held to a higher safety standard. As we have learned in aviation, safety is no accident.

Bryan A. Liang is executive director of the Institute of Health Law Studies, California Western School of Law and co-director of the San Diego Center for Patient Safety, UC San Diego School of Medicine.

Posted by peterpitts at 08:05 AM
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April 18, 2008

Slamma JAMA

by Peter Pitts

What ever happened to dialogue and ... ethics?

In it's reporting/editorializing on the recent "what-did-Merck-know-and-when-did-it-know-it" saga, JAMA accuses some pretty high-powered healthcare professionals of shilling for shillings.

Now it comes to light that the folks JAMA denounced weren't even given the chance by the Sultans of Science to defend themselves.

Here's what the Washington Post says,

"Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them. Several of those people yesterday called the conclusions incorrect, incomplete or unfair."

Don't "real" journalists" seek out both sides of the story? Don't real scientists?

Posted by peterpitts at 02:22 PM
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April 15, 2008

"Evidence-Based" Rx Miscues

by Peter Pitts

From today's Washington Times ...

"Evidence-based" Rx miscues

Hillary Clinton, Barack Obama and John McCain have been traveling the country laying out their solutions to the problem of escalating health-care costs. One plan they all favor is ramping up federal funding for so-called "evidence-based" medicine.

The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.

Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.

That was certainly the case for CATIE, or the Clinical Antipsychotic Trials in Intervention Effectiveness. This federally funded, $40 million study concluded new "atypical" nonpsychotic drugs are no more effective at treating schizophrenia symptoms than are older drugs. Because this finding flatly contradicted psychiatrists' real-world observations, CATIE had no impact on which drugs were prescribed for schizophrenia.

Like most large-scale trials, CATIE took a one-size-fits-all approach to medicine. Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.

Modern science disproves that notion. Everyone has a unique biological makeup. Health-care professionals need to be given the autonomy to tailor their treatments to the specific needs of their patents.

Evidence-based programs rarely provide that autonomy. In the long run, this often results in higher costs.

Consider an overweight man who is forced to take a cheaper, less effective anti-cholesterol drug. If he ends up in the emergency room because of undertreated cardiovascular disease, this could end up costing the health-care system significantly more money.

All too often, denying patients access to the right medicines early on means paying for more invasive and expensive procedures later.

The evidence confirms this. A study from the University of Utah examined the relationship between cost-containment programs and the total cost of health care for a number of medical conditions. It found that the tighter the restrictions on which treatments a physician could administer, the higher the overall cost of care.

Medical treatment should be based on the specific genetic, clinical and demographic factors of an individual patient. That's how you keep people healthy. In an era of personalized medicine, one-size-fits-all health-care strategies are dangerously outdated.

Choosing short-term savings over long-term results has a pernicious effect on the public purse and public health. Strenuous cost controls compromise patient care.

The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.

Peter J. Pitts is a former associate commissioner of the Food and Drug Administration.

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April 14, 2008

Let's Talk Mandate

by Peter Pitts

Not.

Twenty-nine percent (29%) of American adults favor a national health insurance program overseen by the Federal Government. A Rasmussen Reports national telephone survey found that 39% oppose such a government-led initiative while 31% are not sure.

The survey also found that 46% believe the quality of care would decrease under a national health insurance program while 16% believe that quality would increase. Twenty percent (20%) say the quality of care would remain about the same while 18% are not sure.

At the same time, 42% believe the cost of health care would increase while 25% would expect prices to go down.

While opposing a national program overseen by the federal government, Americans support requiring companies to provide health insurance for their employees. Sixty-three percent (63%) favor such a requirement while 24% are opposed.

Posted by peterpitts at 08:50 AM
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March 31, 2008

And some people think patients need less information?

by Peter Pitts

Many Women Unclear About Breast Cancer Treatments

MONDAY, March 31 (HealthDay News) -- Only half the women diagnosed with early-stage breast cancer clearly understand the risks and benefits of a mastectomy versus a breast-conserving lumpectomy plus radiation, even after they have one of the procedures, according to a new study.
If the woman is black or Hispanic, the chances are even less likely she has adequate information, say researchers whose results appear in the latest online issue of the journal Health Services Research.

The study looked at 1,132 women from Detroit and Los Angeles who had undergone surgery for ductal carcinoma in situ or invasive but not metastatic breast cancer. The women reported their race and ethnicity, knowledge of survival and recurrence, and cancer topics they had discussed with their surgeons, who also were surveyed.

Only 51 percent of women in the study knew that patients who had a mastectomy or a lumpectomy plus radiation had the same five-year survival rate. Forty-eight percent of the women reported not knowing whether cancer recurrence rates were the same for mastectomy as they were for a lumpectomy with radiation.

The survey also revealed that black and Hispanic women were less likely to know about breast cancer survival and recurrence, as were older women and those with less education.

"Overall, women were not generally well-informed about the risks and benefits of the treatment they received," study lead author Sarah Hawley, a research assistant professor at the University of Michigan Health System and research investigator at the Ann Arbor VA Healthcare System, said in a prepared statement.

Women who said their surgeons discussed both treatment options did know more about survival and recurrence rates, but minority women still lagged in survival and recurrence knowledge, Hawley said.

"The authors' finding of racial and ethnic differences in knowledge of survival and recurrence according to surgical treatment are concerning because of their implications about possible suboptimal communication between surgeons and their ethnic minority patients," Dr. Leah Karliner, an assistant professor of medicine at the University of California, San Francisco, who was not affiliated with the study, said in a prepared statement.

However, Karliner said the findings are only associations, and readers can't draw cause-and-effect conclusions about the results.

For women facing breast cancer treatment, they should always ask all of their questions before deciding on a treatment option and make sure they understand the reasons behind their doctors' recommendations for or against a particular treatment, Karliner said.

Posted by peterpitts at 10:28 AM
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Just what we need, an even Dentzer Health Affairs

by Peter Pitts

No, really.

Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.

“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,” Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.

Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.

Good luck Susan.

Posted by peterpitts at 08:27 AM
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March 28, 2008

Claire and Present Danger

by Peter Pitts

Senator Claire McCaskill (D, MO) thinks that the FDA’s draft guidance on off-label communications is "a startling potential change in policy.”

Um, no.

Someone should point out to the Senator that the “policy” that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.

So much for the “startling change of policy.” (Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)

Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change” is "intellectually dishonest or evidence that they are ignorant of the legal context.”

Ouch.

Posted by peterpitts at 08:15 AM
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March 27, 2008

Follow-on, Oh Canada

by Peter Pitts

Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.

Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.

Posted by peterpitts at 08:08 AM
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March 17, 2008

How many economists does it take to screw in a lightbulb?

by Peter Pitts

If the lightbulb is meant to shine a light on the value of new healthcare-related technologies in the context of healthcare technology assessment (HTA) -- then the answer is "one."

And the "one" is Dr. Frank Lichtenberg of Columbia University.

According to Frank, for HTA to yield valid decisions in practice, it is necessary to have reliable estimates of:

ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)

And his main point is that the devil is in the details.

He believes that incorrect estimates of some or all of these key inputs are often used:

ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated

And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.

Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.

Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:

Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States

Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.

and

Murphy and Topel: The value of a life year is $373,000.

Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.

Attention must be paid. Hello NICE. Hello IQWiG. Hello Senators Baucus and Conrad.

If the devil is in the details (and it is) -- it's time for a deep dive beyond simplistic and self-serving "comparative effectivess."

Posted by peterpitts at 08:55 AM
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February 21, 2008

Dr. Bureaucracy vs.The Sustainable Individual

by Peter Pitts

No, not a new horror movie, a new op-ed from today's edition of The Detroit News:

Bureaucrats threaten personalized medical breakthroughs

American health care has come to a fork in the road.

On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.

Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.

Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.

And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.

Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."

Here's the rest of the story.

And to further entice you, here's the concluding paragraph:

We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.

Posted by peterpitts at 08:59 AM
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February 11, 2008

Make Mine a Rubin

by Peter Pitts

By way of Forbes, a real "call it like I see it" piece by Paul H. Rubin, Professor of Law and Economics at Emory University and former Chief Advertising Economist at the Federal Trade Commission and Chief Economist at the U.S. Consumer Product Safety Commission. The topic is the important role of drug reps and, more broady, drug marketing> Rubin's article is both important and timely -- and should serve as an education for those who opt for soundbites rather than sound public health policy.

On My Mind: A Free Lunch
Paul H. Rubin

There's nothing wrong with letting drug reps schmooze with doctors. What's the matter with Americans? They think there is something incestuous about the connection between drug companies and doctors.

Politicians tell them that the drugmakers wine and dine physicians while pushing the latest antibiotic or statin. Utterly corrupted, doctors impose those medications on patients, whether or not the drugs are better than cheaper alternatives.

A pending U.S. Senate bill would require drug companies to report gifts to doctors of more than $25; the House is investigating marketing practices. New York State's legislature plans to hold hearings this year on the relationship between doctors and drug companies. One congressional critic has even compared the drug industry with the tobacco industry, and Senator John McCain has called drugmakers the "bad guys."

What drugs are these legislators taking? Drug company reps offer overworked doctors useful, lifesaving information in an efficient manner. The drug companies are of course motivated by profit, but economists have known since Adam Smith that the profit motive is the best way to induce someone to do something useful. (Disclosure: I consult for the drug industry from time to time, most recently for Pfizer.)

Marketing and research are both information activities; they work together to get effective drugs to patients. The two activities are not in competition for resources. The denouncers of drug companies don't understand this. One of the senators sponsoring the bill suggests that "the millions of dollars these companies spend on marketing ... could be put into research." In fact, drug companies would not switch money from marketing to research. If they cannot market drugs in the best way, they will reduce spending on research. What's the point of inventing a new drug if doctors and patients don't know about it?

Academic physicians think that doctors should obtain information by reading medical journals. Practicing doctors do not have time to comb through the International Journal of Medical Sciences or the Annals of Internal Medicine. A meal with a pharmaceutical salesperson is a time-efficient way for a busy doctor to learn about new drugs, or perhaps a better therapeutic alternative, or a drug with easier dosing or fewer side effects than the old drug. Physicians interact with more than one drug rep, so they have competing sources of information.

Another argument made by supporters of the Senate bill is that promotion leads physicians "to prescribe the expensive new drugs that are being marketed to them when a more affordable generic would do," in the words of one senator. There are three things wrong with this argument. First, manufacturers of generics do not promote those drugs, so it might be
difficult for the physician to learn about generics at all. Second, new drugs lead to better health outcomes. They keep people out of the hospital. A 2007 study by business professor Frank Lichtenberg of Columbia University estimated that a prescription for a new drug (5 years from FDA approval) costs an average $18 more than an older one (15 years on the market) but reduces other medical costs, including hospital and office visits, by $129. Finally, by leading consumers to purchase newer drugs, marketing increases investment in innovation and thus makes research more likely.

A widely cited 2000 article in the Journal of the American Medical Association summarized 29 published studies critiquing the interaction between doctors and drug reps. Notable feature of these articles, as quoted in the summary paper: "No study used patient outcome measures."
That is, in all of the medical literature on drug sales, there was no evidence of harm to patients caused by doctors and drug reps breaking bread. These articles were written by physicians who by their oaths put patient welfare at the top of the list, but they were critical of the industry based on analyses that totally ignore this measure.

A recent report shows that the life expectancy of Americans is at its highest level ever and will continue to increase. It is truly amazing that this society keeps coming up with ways to demonize and penalize an industry that has provided us with so many benefits.

Posted by peterpitts at 11:07 AM
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February 04, 2008

Stone of Arc

by Peter Pitts

Yes, Virginia, while some media will exploit public health myths for their own venal purposes, others can play an important role in advancing the public health.

By now you are certainly familiar with the controversy surrounding the ABC program “Eli Stone” – where the title character (an attorney who has spiritual visions) goes to court to prove that childhood vaccinations cause autism.

Well, rather than piling on to the already crowded anti-pharma bandwagon, here is what the New York Times said in an editorial:

“Nevermind that such authoritative bodies as the Institute of Medicine of the National Academy of Sciences, the Centers for Disease Control and Prevention and the World Health Organization have found no evidence of a causal link. Nevermind that the incidence of autism continued to rise even after mercury preservatives were phased out of almost all childhood vaccines. As far as Eli Stone is concerned, you can’t just rely on science. Sometimes you have to go on faith.

The American Academy of Pediatrics tried unsuccessfully to get the episode canceled, fearing that it could deter parents from getting their children vaccinated, exposing them to far greater dangers from disease. Let’s hope that any parents who watched don’t make that mistake. And let’s hope that in future episodes, Eli Stone and ABC show better judgment in picking causes.”

Posted by peterpitts at 09:49 AM
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January 10, 2008

The Cost of Co-Pays

by Peter Pitts

Offering lower drug co-payments to people with diabetes, high blood pressure and other chronic diseases could increase use of preventive medicines, suggests a new study led by University of Michigan and Harvard University researchers.

Higher co-payments that took effect Jan. 1 are designed to help American employers cope with the rising costs of health insurance by making workers and retirees pay more out of their own pockets. But does it help health care outcomes for patients? No.

The study, funded by GlaxoSmithKline and Pfizer Inc., suggests that some drug co-payments should be reduced for some people with chronic diseases. Reducing the amount of co-payments by a few dollars would increase the use of preventive drugs by these patients. And properly treated, these chronic conditions can be managed effectively and cost -efficiently -- keeping patients out of the hospital or other more, er, horizontal places.

The researchers looked at a major private employer that made some medications free to employees and slashed co-pays for other drugs by 50 percent. This led to a significant increase in employees' use of preventive medicines.

The study authors also looked at another employer that kept co-payments at the same levels and found it didn't show the same increase in employee use of preventive medicines.

The findings were published in the January/February issue of Health Affairs.

"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."

Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.

Posted by peterpitts at 05:46 PM
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January 08, 2008

The Skittles Defense

by Peter Pitts

From the WSJ Health Blog ...

Claiming he popped Merck’s former painkiller “like it was Skittles” (sic), the pitcher expressed his concerns about the potential impact of the drug on his health. “Now these people who are supposedly regulating it tell me it’s bad for my heart. I don’t know what the future holds because of the medicine I’ve eaten, but I trusted that it was not harmful,” Clemens told Mike Wallace.

I may be wrong here, but I do not believe the FDA-approved label for Vioxx included any mention of either stupidity or hanging fastballs.

Posted by peterpitts at 11:07 AM
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January 07, 2008

Thanks Son

by Peter Pitts

Previously uninsured adults who received Medicare coverage reported improvements in health, especially those with cardiovascular disease or diabetes, according to a study in the JAMA.

Uninsured near-elderly adults, particularly those with cardiovascular disease or diabetes, experience worse health outcomes and use more health services as Medicare beneficiaries after age 65 years than insured near-elderly adults. Because chronic diseases are prevalent and insurance coverage is often unaffordable for older uninsured adults, the impact of near-universal Medicare coverage at age 65 years on the health of previously uninsured adults may be substantial, according to researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston.

The researchers conclude that providing earlier health insurance coverage for uninsured adults, particularly those with cardiovascular disease or diabetes, may have considerable social and economic value for the United States by improving health outcomes.

Posted by peterpitts at 09:58 AM
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January 02, 2008

Thanks Mom

by Peter Pitts

My mother-in-law hates George W. Bush. That doesn't make her special -- but it has made her impossible to talk to about Part D. She thinks it's "Bush's thing" and has refused to even consider signing up for coverage.

Over the holidays, as she was complaining about her prescription medicine expenses, I went to the well one more time and advised her to check into signing up for Medicare drug coverage.

And you know what? She did.

She may still hate the President, but she sure loves her Part D.

Oh yes -- she lives in California.

Posted by peterpitts at 09:14 AM
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December 19, 2007

And a tax credit for being a vegan

by Peter Pitts

What's worse than a bad idea? How about a bad idea without any details.

SAN FRANCISCO (AP) -- Mayor Gavin Newsom wants large grocery stores to help fight obesity by paying fees on sodas and other beverages they sell in San Francisco.

Newsom has asked his staff to prepare a law that would charge retail chains for stocking Coke, Pepsi and other drinks sweetened with high fructose corn syrup.

Mayoral spokesman Nathan Ballard says the size of the fee and how it would be assessed still have to be worked out.

He says there's a direct link between sweet beverages and obesity, which puts added pressure on San Francisco's health care system.

If the bill is approved by the Board of Supervisors, money generated from the fee would go toward a city program that emphasizes exercise, diet and other preventative health measures.

A direct link to obesity? The only direct link is the one between calories in and calories out. That being the case, perhaps the Mayor should also consider a "sit on your tuchus tax" on the sale of flat screen televisions.

The idea to tax soda is well, flat.

Posted by peterpitts at 10:11 AM
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December 18, 2007

L'Etat, C'est moins NICE

by Peter Pitts

In September I participated in a conference of French health care regulators, pharmaceutical firms and members of the Assemblée Nationale. The keynote of the event was a speech by the French Minister of Health, Madame Roselyne Bachelot. She gave a thoughtful presentation on the need for all concerned to work together for the public good.

Recently she showed that she meant what she said with these comments in front of the French Parliament:

"Je suis enfin défavorable à ce que l'on intègre,à l'instar du NICE, la notion de quality-adjusting life-years dans les indicateurs d'éfficience médico-économique. Cela ne correspond pas à la culture dont la HAS doit s'inspirer."

For those of you who took Spanish in high school, here's the translation:

"I am not in favor, as it is done by NICE, to integrate the notion of quality-adjusting life-years among the indicators for medico-economic efficiency. It does not correspond to the culture which should inspire the HAS."

(HAS = La Haute Autorité de Santé. HAS roughly corresponds to NICE in the UK or CMS in the US -- not precisely, but you get the idea.)

Well, amen to French culture and a big "Bon Courage!" to Madame Bachelot.

Posted by peterpitts at 02:35 PM
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December 14, 2007

Value-Based Insurance Design

by Peter Pitts

Yesterday I participated on a "blogger conference call" with Mark Fendrick (University of Michigan) and Michael Chernew (Harvard University). They are the co-directors of the Center for Value-Based Insurance Design.

The VBID Center sounds like an interesting proposition. For more detail check out their website:

http://www.sph.umich.edu/vbidcenter/

Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.

And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!

I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.

Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.

The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.

The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.

Posted by peterpitts at 08:24 AM
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December 12, 2007

Electile Dysfunction

by Peter Pitts

That's the title of Matthew Arnold's cover story in the December issue of Medical Marketing & Media -- "Outlook 2008: Electile Dysfunction."

Here’s how it begins:

"A cautious FDA sweating product safety issues and going slow on new approvals. An election year in which healthcare tops the agenda. Increased oversight, increasingly demanding payors and ever more aggressive generic competition.

Throw in some gloomy global market trends, and 2008 promises to be a tough one for a pharmaceutical industry trying to dig its way out from under a mountain of looming patent expirations on key products. If 2007 was a year of disappointment—with hotly anticipated products like torcetrapib, rimonabant and Galvus failing to make it to market and safety jitters hitting others, like Avandia, Zelnorm and Exubera— 2008 looks like more of the same. For all the talk about acquisitions, big pharma firms sitting on large cash piles might look to Pfizer's inability to translate scale into lasting dominance and think twice—if there were even anything attractive left to buy. And the trickle of really innovative new products coming down the pipe will have to vault high hurdles to make the grade at the FDA, with Rep. Henry Waxman breathing down Andrew von Eschenbach's neck."

And here’s the conclusion:

"At least one FDA watcher is more sanguine. “In a political year, the FDA is going to understand that it needs to be apolitical,” says Peter Pitts, director of the Center for Medicine in the Public Interest. “FDA is in the business of protecting and advancing public health. It's not an agency that wants to deal with politics at all, but it's been buffeted by very potent political winds from the outside.”

The Reagan-Udall Foundation established by the FDA Amendments Act will, together with the FDA's Critical Path Initiative, revolutionize drug development, says Pitts. “By streamlining and improving the science of drug regulation, we can bring drugs to market more rapidly and safely by helping companies fail faster, so that they can reinvest those resources in more successful propositions,” says Pitts. “Ultimately, Critical Path is like a game of Chutes and Ladders, helping companies avoid the chutes and scale the ladders.”

Here's a link to the complete piece:

http://www.mmm-online.com/Outlook-2008-Electile-Dysfunction/article/99533/

And be sure to check out the predictions of the six health care cognoscenti interviewed for the story.

Posted by peterpitts at 12:46 PM
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December 11, 2007

Rockville-on-Thames

by Peter Pitts

Last week I gave a brief presentation to folks at the MHRA on the current state of affairs at the FDA. It was a Chatham House rules affair, so I don't want to reveal any confidences -- but the first question I was asked is worth sharing,

"How can the FDA earn back its reputation?"

(Nothing like a softball question from Our Regulatory Cousins.)

Without going into too much detail here, suffice it to say that what followed was a rather robust conversation about the best ways to stand up for what's right in light of the unsavory tactics of many on our side of the pond.

There is indeed a "special friendship" between FDA and MHRA -- and we must all find ways to strengthen these important bonds of regulatory solidarity.

Posted by peterpitts at 12:38 PM