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Friday, August 14, 2009

In the rush to control health-care costs, don't chill biotech drug innovation


By Tom Still
It's not the stuff of a town hall shouting match, but one of the most far-reaching elements of the national debate over health care is the question of how long to protect breakthrough drugs produced by biotechnology from copycat generics.

One side argues that five years of exclusive marketing rights is enough of a head start for expensive biotech drugs, called "biologics." Members of this camp believe the sooner generic biotech drugs -- called "biosimilars" -- can hit the market, the better for consumers.

Others contend that research into life-saving biologics could screech to a halt if scientists and biotech companies, such as many emerging firms in Wisconsin, can't count on more time to recoup their research, testing and development costs. They want a 12-to-14 year period in which innovative biologics are protected from competition by knock-off drugs.

As the issue moves to the Senate, lawmakers such as Wisconsin's Herb Kohl and Russ Feingold should vote to grant at least 12 years of biologic protection. Anything less could crimp innovation in an industry in which American ingenuity is the world's gold standard -- and it might expose consumers to generic drugs that aren't really generic.

Biologics are medicines made from complex proteins in controlled containers of living cells. They're different from traditional pharmaceuticals, which are the product of chemicals organized in comparatively simple molecules. In fact, the term of art for biologics is often "large-molecule" pharmaceuticals, while traditional drugs are called "small-molecule" pharmaceuticals.

The problem with large-molecule drugs is that they usually come with equally large price tags. Some of the most successful biologics for cancer, anemia and multiple sclerosis can cost $20,000 to $50,000 per year; biologics from some rare diseases can top $200,000 per year because the markets are so small.

That's why some health-care reformers are pushing for five-year protection periods. They point to generic small-molecule drugs, which can cut costs by up to 60 percent compared with the original patented drug, and with little or no risk to the users.

There are some important differences between generic drugs and biosimilars. It is difficult to verify that a copy of a biologic is exactly the same as the original. In fact, biosimilars are called biosimilars for good reason: They may be close to the real McCoy, but they're not likely to be identical.

That poses important safety questions for patients and medical professionals. Biologics only reach the market after extensive review by the U.S. Food and Drug Administration and rounds of clinical tests. Generic small-molecule drugs don't undergo FDA review because they're exact knock-offs. Biosimilars may require some clinical trials and review before getting the FDA's stamp of approval -- and before medical professionals feel confident in prescribing them.

Another danger associated with a short protection period for biologics is the threat to innovation. The development of biologic drugs is a riskier investment proposition than traditional small-molecule drugs. Development times are longer. Manufacturing is often more complex and expensive. The failure rate during clinical trials is high, which means investors often spread their bets over a number of drugs in the hope one will hit the jackpot and pay for all the rest.

Tell those investors they only have five years to recoup their costs versus 12, and they might not invest at all -- which means promising new drugs never hit the market.

The rush to a one-size-fits-all approach to drug development may appeal to some federal policymakers, but it's not consistent with a core American strength -- innovation. To the extent the law fails to protect innovators, our nation will simply have fewer of them.

Controlling health-care costs is vital, and the existing system appears unsustainable in many ways. But protecting innovation and rewarding risk is just as important as cost for those millions of patients who are awaiting a breakthrough cure. Striking a proper balance is best for health care in America.

-- Still is president of the Wisconsin Technology Council. He is the former associate editor of the Wisconsin State Journal in Madison.

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Comments: 3

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At August 30, 2017 at 10:59 PM, Blogger قمم التميز said...


شركة نقل اثاث
الاثاث من الاشياء التى نستطيع ان نبذل فية الكثير من الجهد والوقت من اجل ان يتم القيام باعمال النقل من مكان الى اخر سواء الى اى مكان فى المملكة او اى مكان خارج المملكة ، فاعمال النقل من الخدمات التى تبدو لنا انها سهلة وبسيطة الا انة فى نهاية الامر من الخدمات التى تؤدى الى التعرض الى مشاكل كثيرا من الصعب ان يتم القيام بحلها من الكسر والخدش والتلفيات والضياع ،شركة قمم التميز من اهم وافضل شركة شراء اثاث مستعمل بالرياض
التى تحقق اعلى مستوى من خدمات النقل للاثاث والقيام بالاتفاق مع مركز التعاون الخليجى من اجل ان يتم الحفاظ على الاثاث ضد اى مشكلة ، فاذا كنت فى حيرة من امر النقل فتاكد انك الان تمتلك افضل الشركات المميزة الخاصة باعمال النقل من خلال الاعتماد على توفير عدد من الخدمات المميزة . بيع اثاث مستعمل بالرياض
شركة قمم التميز على وعى كبير باعمال النقل والتى تحقق افضل مستوى من خدمات النقل التى تؤكد ان الاثاث يتم الانتقال من مكان الى اخر دون ان يتم التعرض الى اى مشكلة من اهم الخدمات المقدمة الاتى :- شراء اثاث مستعمل بالرياض
الاعتماد على افضل النجاريين المتخصصين فى اعمال الفك بطريقة حرفية لان الاثاث يحتاج الى القيام باعمال الفك الى قطع اصغر من الممكن حتى يتم حماية الاثاث من التعرض الى اى تلفيات او ظهور اى عيب فى الاثاث بعد التركيب . شراء اثاث مستعمل الرياض
شركة تخزين اثاث
تخزين الاثاث من المهام التى نجتاج الية فى اوقات معينة اثناء الانتقال من شقة الى اخر او القيام بالسفر لفترات طويلة ، فالحرارة المرتفعة والرطوبة والاتربة الناعمة تؤدى الى ظهور التشققات و تؤدى الى التكسير المفاجىء للاخشاب اثاث مستعمل بالرياض
، فاذا كنت فى حيرة من اعمال النقل فتعاون مع شركة المتخصصة فى اعمال التخزين من الامور التى لابد من القيام بية بطريقة مميزة على ايدى متخصصين فى القيام بهذة الخدمة .
شركة قمم التميز من اهم الشركات التى تقوم بانشاء مستودعات طبقا لمعاير ذات جودة مميزة والتى تساعد فى الحفاظ على الاثاث ضد اى عيوب او اى مشكلات تظهر مع مرور مدة التخزين بالاضافة الى ان المستودعات مقسمة من الداخل الى اماكن مخصصه للزجاج واماكن مخصصة للاخشاب وهكذا حتى يتم الحفاظ على الاثاث فعليك ان تتعاون وتتواصل مع اثاث مستعمل
والارقام المتواجدة على الصفحة من اجل ان تتم الحفاظ على الاثاث ضد اى تغيرات من الممكن ان تحدث ، بالاضافة الى اننا نقدم عقود مميزة فى اعمال التخزين فى مقابل ارخص الاسعار

 
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