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November 28, 2006

The Male Biological Clock: It Ticks, Too

by Stephanie Koze

Now that erectile dysfunction, or ED, is out of the closet and men are seeking appropriate medical care to treat it, the time has come to address another sensitive subject – the impact of the ticking, male biological clock upon fertility and birth defects in offspring.

Medical experts know that male fertility declines with age. And, newer research has led to strong speculation that men 40 and older are more likely than younger men to produce children with medical conditions, such as schizophrenia and autism. Among other reasons, DNA strands in the sperm of older men are more likely to break – leading to potential birth defects.

While it is relatively common to hear about women’s concerns regarding their ticking biological clocks, we need to do more to educate couples that a woman’s age is not the only factor to consider when attempting to conceive. A male’s age is important, too.

As people put off having children due to careers, delays in finding the right partner and many other issues, medical professionals, the media and couples need to discuss the male’s age, as well as the female’s age, when it comes to having children.

Posted by stephanie_koze at 12:28 PM
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November 27, 2006

Remember, you can't spell "Rational Use of Medicine" without R-A-T-I-O-N

by Peter Pitts

I was in Montreal recently giving a lecture on why ideas -- and not just politics -- matter in health care. On my way to the hotel where the conference was being held I saw the headline of the Canada's newspaper of record, The Toronto Globe and Mail. In bold type, across the entire width of Page One was the headline:

Vow Broken on Cancer Wait Times

"It was a bold promise backed by billions of dollars in new government funding: Cancer patients should not have to wait longer than four weeks to obtain critical radiation treatment."

"Four weeks. That's double the maximum waiting time oncologists recommend but still seemingly better than the cancer-care limbo many patients faced when Liberal health minister Ujjal Dosanjh and his provincial counterparts made the announcement last December."

"But figures obtained by The Globe and Mail show a staggering 70% of Canadian hospitals surveyed are unable to meet that standard for prostate cancer patients."

You get the picture?

And that was only the most recent installment of a weeklong series on how the Canadian health care system is failing cancer patients.

The next day's headline read:

Provincial drug disparity a roadblock to cancer research

"For the first time, Canada is unable to participate in a key clinical cancer trial because patients are not getting the best known treatment."

"Since most provinces don't fund Avastin, a crucial drug in the fight against colorectal cancer, Canadian patients could not join a trial run by the National Cancer Institute in the United States, which is studying what drug is most effective with chemotherapy — Avastin or Erbitux — or if they work best given together."

Please pass along this important and devastating series to anyone who recommends that what we need in the US is a system "just like Canada."

Here's a link to the series:

http://www.theglobeandmail.com/cancer

It's a worthwhile, disturbing read.

Posted by Peter Pitts at 09:46 AM
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November 22, 2006

How Critical is the Critical Path?

by Peter Pitts

New Hearing for Suit Against FDA
Associated Press

A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.

The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.

The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.

In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.

The FDA, in turn, appealed and asked for the full court to rehear the case.

Posted by Peter Pitts at 08:41 AM
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November 17, 2006

PD3

by Peter Pitts

Since there's a general belief that the pharmaceutical industry invents new diseases, I thought I'd get in on the fun with Part D Denial Disorder or PD3.

The unfortunate symptoms of PD3 are easy to spot: feelings of inadequacy when it comes to the private sector, the irrational belief that senior citizens have no cognitive abilities and, non-dietary aversion to donut holes. A less severe but related condition has been identified as Pelosian Ideation Syndrome (PIS) -- which can manifest itself through both disorientation and lack of balance.

If you feel you may suffer from PD3 stop reading this blog immediately and log onto the Public Citizen website for immediate relief.

A new study, funded by PhRMA and conducted by the Amundson Group, shows (among other interesting things) that in 2005 the average Medicare beneficiary filled 2.5 prescriptions per month -- but in 2006 (and with Part D coverage) that number jumped to 4.0 prescriptions per month. (The study found that the increase was consistent across all ages.)

The study also measured the average out-of-pocket cost for each day's supply of medication. And to those PD3-free readers, the findings should come as no surprise -- a per unit measure shows a 74% reduction in patients' out-of-pocket costs from $1.58 BPD (Before Part D) to 40 cents APD (After Part D).

More access at lower cost. Pretty sweet double play.

As for positive patient outcomes, the study measured the impact of Part D on access to drugs for specific chronic conditions that are highly prevalent in the Medicare population: Alzheimer's disease, high cholesterol, diabetes, hypertension, and osteoporosis -- all conditions that are often undertreated.

For each of these chronic conditions, the study found that there was a significant increase in the number of prescriptions filled per month -- suggesting that patients with these conditions are getting treatment under Part D that they were not previously receiving.

Note: In rare but advanced cases of PD3, symptoms can also include the belief that chronic disease should not be treated early and aggressively and the inability to differentiate between Santa Claus and the Non-Interference Clause.

If, after reading this blog, you are experiencing feelings of guilt and inadequacy, please consult a specialist -- Dr. Mark McClellan.

To view the complete study, click on the link below:

http://www.phrma.org/files/Amundsen_Study.pdf

Posted by Peter Pitts at 02:11 PM
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November 14, 2006

Adaptation

by Peter Pitts

Despite the midterms and continued brickbats from Grassley, Waxman, Hinchey, et al., the persistent and quiet revolution going on inside the FDA continues.

The most recent example of this ray of hope is the agency’s championing of adaptive clinical trials. "Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.

Yesterday, Deputy Commissioner Dr. Scott Gottlieb made such a point at a Manhattan Institute talk – and it sure was refreshing.

Scott’s full remarks can be found by clicking the link below:

http://www.fda.gov/oc/speeches/2006/manhattaninst1113.html

Posted by Peter Pitts at 12:30 PM
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November 13, 2006

VC funding lags in diagnostics

by Kelly McKenna

It's clear that diagnostics offer huge potential: reducing costs, predict an individual's risk of acquiring diseases and responding to specific therapies…the list goes on. Yet, venture capital funding has been minimal compared to investment in other healthcare areas – pharma, biotech and even devices. Key reasons may include a lack of understanding of this new business model, no blockbuster (big pharma) product prospects, slow-moving reimbursement and a general skepticism due to the misperception that few to no companies have shown a tangible cost savings.

Smaller, early stage diagnostics companies rely on funding for R&D. And, unfortunately, there are few successes, even though these companies can bring products to market and generate revenue quicker because their products typically don’t undergo the lengthy FDA review and approval process. Companies like Genomic Health and XDx have generated significant funding, commercialized products with several in the pipeline (essential to these companies long-term success) and paved the way for start ups. The diagnostics business model does work, but it requires investment and commitment. Diagnostics companies are and will enable the reality of personalized medicine.

Posted by kelly_mckenna at 06:29 PM
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Zesty Italian

by Peter Pitts

The grass is always greener, right?

Some US politicians are advocating the adoption here at home of a Euro-style, deny-and-delay health care system -- but, as P.J. O'Rourke has famously quipped, "If you think health care is expensive now, just wait until it's free."

It's never as simple as some politicians make it sound. And that's as true for price controls as it is for things like drug importation.

It's important to remember, as the debate over revoking the non-interference clause gets under way within the "first 100 hours," that price controls = choice controls. Just ask our British cousins how nice NICE is or the Germans about IQWIG or the French about their government's initiative to get their docs to prescribe fewer medicines for the sake of the budget -- and patients be damned.

And of course, when it comes to the Italians -- you can see for yourself in yesterday's Washington Post what Alberto Mingardi of The Instituto Bruno Leoni has to teach us about wistfully contemplating the adoption of a Euro-style health care system without understanding the significant unintended consequences.

The title says it all.

A Drug Price Path To Avoid
By Alberto Mingardi

Sunday, November 12, 2006; Page B07

The next speaker of the House, Rep. Nancy Pelosi (D-Calif.), has let it be known that within her first 100 hours on the job, she will move to allow the government to negotiate directly with pharmaceutical companies to obtain lower drug prices for Medicare patients.

Her plan would create a Medicare drug program that looks a lot like the system we have in my country, Italy, where drug prices are among the lowest in Europe. And that's pretty low, considering that drugs in Europe average about 60 percent less than in the United States. Even as U.S. prices rose, Italian drug prices decreased by 5 percent last year.

At first glance, this might seem an enviable model for America to follow. But before Pelosi rushes down the road to Italian-style health care, allow me to offer a word of caution. Italy is hardly a health-care paradise. In fact, it's more like a quagmire of red tape.

For the most part, Italy's lower drug prices are the product of government price controls. The state purchases nearly 60 percent of the nation's prescription drugs. And it supposedly negotiates prices directly with pharmaceutical companies. But since the Italian government controls such a disproportionate share of the market, it in effect dictates drug prices.
In Italy, these price controls have created a number of problems.

First, they distort the laws of supply and demand. Because of the country's artificially low drug prices, demand for pharmaceuticals is artificially high -- higher than it would be under free-market conditions.

The point is that the government's attempt to force down drug prices has not reduced overall health-care spending. Rather, it has resulted in a spike in demand -- which is one reason why Italy's health-care spending has skyrocketed, growing nearly 68 percent between 1995 and 2003.

As for the quality of Italy's care, that, too, is suffering. With demand for drugs rising, the Italian government has attempted to save money by adopting reimbursement policies that favor certain drugs over others. Unfortunately, the most innovative products often aren't considered reimbursable by the government precisely because they are the most expensive.

It's a great system if you just need an antibiotic. But if you're hoping to avoid open-heart surgery through access to a miracle drug, it can be a nightmare.

And Italians are lacking more than just choice in cutting-edge drugs. They also lack information. According to a recent survey, more than 50 percent of Italy's patients believe that the national health service cannot even supply adequate information about treatments and drugs.

The economy is also harmed. Because it's simply not profitable for companies to invent cures in Italy, price controls have decimated Italy's pharmaceutical industry. Today not one of the world's 50 largest drug manufacturers has its headquarters in Italy, even though the country is the world's seventh-largest economy. Because most drug and biotechnology companies are outside Italy's borders, there are only 84,000 pharmaceutical workers in Italy's entire drug industry. The industry has become a perfect target for Italy's politicians, because they can rail against it with little political downside. The more we follow this path, the less likely it is for Italian companies to develop valuable innovations -- at great risk for both our economy and our health.

So by attempting to hold down drug prices, the Italian government has deprived its citizens of the best care without reducing health-care spending. And it has deprived the country of what could be a vibrant sector of the economy. In their rush to revamp Medicare, U.S. policy leaders should be careful not to make the same mistake.

The writer is a director of the Istituto Bruno Leoni, an Italian free-market think tank.

Posted by Peter Pitts at 07:14 AM
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November 08, 2006

The Letter "P"

by Peter Pitts

So now what happens?

Post-election it’s all about the letter “P.”

I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive medicine, and the participatory critical path.” ...

… and we will move to a House of Representatives that is focused on politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.” And that’s particularly dangerous right now because of PDUFA.

On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours” to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).

You can also bet we’ll see more rhetoric over plans for phony importation schemes.

It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.

Which means we all must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.

America's health is too important to be about partisanship or about profits. It must be about progress, about patients.

We must keep our eyes on the prize.

Posted by Peter Pitts at 10:55 AM
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November 07, 2006

Localizing National News

by MaryEllen O'Donohue

A recent study conducted by the Audit Bureau of Circulation raises questions about the popularity of major newspaper dailies versus their more localized counterparts. It revealed that major newspapers such as The New York Times and Washington Post had sold fewer papers than local dailies, such as the New York Post and New York Daily News. What’s more, major newspapers are already experiencing a slump due to the Internet’s impact on how consumers access news, and advertisers are allocating more money to online promotion to maximize audience reach.

As public relations professionals, we must not underestimate the appeal of more localized publications. Consumers have access to national news from a variety of media sources, including radio, television and the Internet. Yet, local stories that readers can relate to are harder to come by. Health and lifestyle reporters at regional dailies and weeklies across the country stress the importance of a local angle that speaks directly to their readership. It is no longer enough to pitch “national” news to regional dailies and weeklies, which they can obtain and run from national wire services. Whether it means highlighting key local market statistics about disease prevalence or reinforcing patient impact within a specific area, there are numerous avenues to pursue to localize national news and maximize your chances of securing local media print placements.

The right pitch—one that is targeted appropriately to local market papers, can result in a story that is effective with readers on a local level and drive action.

Posted by maryellen_o'donohue at 02:05 PM
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November 06, 2006

Hark! The Herald Actress Sings.

by Peter Pitts

Steph Koze makes a very good point -- health care is all about options ... and knowing about them. That's precisely why an informed, educated consumer is essential.

But as far as heeding advice from a source as, well, telegenic as Suzanne Somers, my advice is also he same as Ms. Koze's -- ask your doctor.

Posted by Peter Pitts at 04:02 PM
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A targeted approach to PR for small biotechs

by Kelly McKenna

Bioetchs can't compete with the marketing muscle and budgets of big pharma. Traditional consumer marketing campaigns, including the use of celebrities and sports figures, are just not possible for the early to mid-stage biotechs. Additionally, many of these companies focus on niche diseases, developing drugs, devices and technologies for small patient populations, to secure market share and establish leadership. These factors make generating media attention and coverage very difficult. For these niche disease categories, quality of life doesn't resonate as much with reporters either because such small populations are affected. It’s all about the data.

PR teams needs to be targeted and cost efficient, focusing heavily on numbers – data differentiating the product and demonstrating cost savings over treatments/technologies currently on the market. Often it’s overcoming the enormous hurdle of creating a new standard of care and changing physician behavior. As such, communications efforts need to be targeted to niche healthcare professionals, patients and their caretakers.

The best approach – in terms of cost effectiveness and credibility, the biggest bang for your buck – is through specific professional third-party organizations and patient advocacy groups. We’re constantly identifying new channels such as newsletters, member emails, Web site activities and ongoing programs to reach these groups and their constituents on behalf of our clients. One hit to the right outlet, and your message goes a long way.

Posted by kelly_mckenna at 01:34 PM
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What is "efficiency?"

by Peter Pitts

There’s a lot of talk about how our use of pharmaceuticals needs to be “more efficient.”

But what does “efficient” mean?

Does it mean more cost-effective or more medically efficient? Does it mean either?

Let’s call a spade a spade — “efficient” means short-term savings for payors (although, as we shall see in a moment, only in penny wise but pound foolish ways). Restrictive formularies (in the US both public and private) and health care systems (in the EU, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.

Perverse in so many ways — not the least of which is that “savings” are entirely transitory.

Consider the facts. A longitudinal prospective study by Dr. Susan Horn, et al.*, examined the relationship between HMO cost-containment strategies and utilization and total cost of health care for a number of medical (non-psychiatric) illnesses. The study showed that the tighter the formulary restrictions, the higher the overall cost of care — and what drove the increased costs was the association between formulary restrictions and utilization of care.

A blunter way of putting this is that “efficient,” as the term has come to be defined, has nothing to do with patient care. “Efficient” is a cost-based word and patient-centric concerns be damned.

Welcome to the world of health technology assessment, aka evidence-based medicine, aka rational use of medicine.

And remember, you can’t spell rational without r-a-t-i-o-n.

* If you would like to see the full study, here’s the full citation: Horn SD, Sharkey PD, Tracy DM, et al., Intended and unintended consequences of HMO cost-containment strategies: results from the Managed Care Outcomes Project. Am J Managed Care 1996;2:253-264

Posted by Peter Pitts at 09:00 AM
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Hark! The Hormone Debate Continues.

by Stephanie Koze

Remember the major pandemonium that ensued when the results of Estrogen Plus Progestin Trial of the Women’s Health Initiative (WHI) were announced in July 1992?

Instead of protecting postmenopausal women from breast cancer and heart attack -- among other potentially deadly conditions -- combined estrogen and progestin was shown to actually increase their incidence. As a result, many physicians stopped prescribing hormone therapy, and women dumped their hormone therapy by the truckload.

Now, celebrity Suzanne Somers’ newest book, Ageless, raises more questions about hormone treatments. In her book, she claims compounded or bio-identical hormones (hormones produced from natural products, such as soy and wild yams, mixed in pharmacies and sold without a prescription) are far safer than synthetic hormones studied in the WHI.

Ms. Somers may have a point. It makes sense that naturally occurring products might be safer than man-made products. But, just because a hormone therapy is produced from a natural product does not make it safer than a synthetic product.

When it comes to hormones, women need to do their homework, speak with their physicians and evaluate carefully whether any type of hormone, bio-identical or synthetic, is right for them.

Posted by stephanie_koze at 08:44 AM
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November 03, 2006

M&A – The Best Medicine?

by Michael Martell

Size matters! Especially for pharmaceutical companies size is a critical success factor. It takes billions to develop and launch new drugs and the risk of a non-approval or unexpected side effects is omnipresent. This might be a break-down for small or mid-sized companies.
From this perspective, consolidation is reasonable and apparently inevitable. But on the other hand, the employees seem to be the losers of the spate of fusions. High expectations of increasing income and gaining benefit from synergies lead directly to the reduction of jobs. After absorbing Schering, Bayer confirmed the reduction of 6.000 jobs worldwide, which is the tenth part of employees in the pharma divison of both companies.
Furthermore, M&A is not always the best medicine. A current study from Ernst & Young shows that only every third consolidation leads to substantial valorization.

M&A may be best medicine for mid-sized pharma groups

If once is happenstance and twice is coincidence, the third pharmaceuticals deal in a week begins to look like a clear trend towards accelerated industry consolidation.
Belgian UCB yesterday announced a €4.4bn ($5.6bn) takeover of Germany's Schwarz Pharma; Merck of Germany last week acquired Serono of Switzerland for €10.6bn; and Nycomed of Denmark swiftly followed with a €4.5bn agreed purchase of the drugs division of Altana of Germany.
In a related sector, the bidding war for Pliva, a Croatian generics company, separately reached a turning point when Actavis of Iceland stood aside after Barr Laboratories of the US raised its offer to $2.5bn.
Some factors are common between all the transactions, and point to the likelihood of further consolidation among Europe's mid-sized pharma companies.
But analysts and bankers were cautious yesterday to stress the differences between the deals and some element of chance in the close timing of the transactions.
The clearest connection is the German market, which has long supported domestic pharmaceuticals companies with attractive drug prices, but which has begun health reforms - putting greater pressure on those businesses that had not sufficiently diversified their sales base abroad.
"Over the last few years there have been some concerted efforts to cut healthcare bills and one of the key areas of focus has been pharmaceuticals," says Alex Grosvenor, senior analyst with Wood Mackenzie, a specialist consultancy.
The tensions have increased as deregulation has reduced the need for international companies to seek local partners in each European nation as a precondition for local market access for their products.
Another common denominator has been the struggle to research and develop new products.
While the large pharmaceuticals groups have tried to reinvent themselves in an effort to boost innovation with mixed results, the challenge has been even greater for smaller companies with fewer resources and a more limited pipeline.
"If you don't have a product pipeline, you are in the mergers and acquisitions business," says one medium-sized pharmaceuticals company.
A final factor driving the recent deals has been tight family ownership, which can make building the necessary relationships and assurances for a deal more fraught. Serono was controlled by the Bertarelli family; Schwarz by the eponymous family; and Altana by the Quandt family.
"You can make a case for any pharma to merge with any other, but where they are privately held, consolidation is not only inevitable - it is taking a long time," says Martyn Postle, director of Cambridge Healthcare & Biotech, a consultancy. "If they sell, they risk their place in society and ask whether they have sold their family's heritage."
Not all the companies involved in the recent spate of deals - or other potential contenders - are in the same situation.
While Altana and Serono's deals smacked of desperation after failed auctions, advisers to UCB and Schwarz stress this was a strategic deal.
Meanwhile, some other mid-sized companies are confident they can remain independent.
The UK's Shire Pharmaceuticals has argued it has long adopted a "speciality model", aiming to be a leader in a narrow range of therapies. Its executives have repeatedly stressed their confidence in their independence, boosted by both a strong medium-term pipeline focused on speciality drugs that do not require an extensive primary care sales network, and a robust international distribution network.
Boehringer Ingelheim of Germany, although family controlled, has also followed a similar model, and ensured it has a sales and marketing infrastructure to support its medicines worldwide.
But others may well follow the consolidation trend.
Lundbeck of Denmark, controlled by a family trust, is in talks.
The combination of family stakes, small scale and a limited long-term pipeline suggest the pressure on several other companies in southern Europe in the coming months will only increase.

By Andrew Jack, Published September 26 2006, Copyright The Financial Times Limited 2006

Posted by michael_martell at 09:03 AM
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Unhappy Birthday

by Peter Pitts

One hundred years ago today, on November 3 1906, Alois Alzheimer, psychiatrist and pathologist, presented the first case of the disease that later came to bear his name in Tubingen Germany. The patient, Auguste D, developed dementia in her 50s and was so restless and confused that doctors prescribed balneotherapy - day long immersion in a lukewarm bath - to soothe her. When she was at her worst they knocked her out with chloroform.

According to an article in today's edition of The Independent (London), "A cure remains a distant dream."

We must not allow the walls that stymie progress towards finding better treatments (and, ultimately, cures) to stand. President Bush, Dr. von Eschenbach, Dr. Zerhouni, members of Congress: Tear down these walls.

Aggressive measures are required and one important way we can help advance this agenda is to forcefully support, fund, debate, and participate in the FDA's Critical Path agenda.

Posted by Peter Pitts at 08:51 AM
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