The DJP Update

DJP Update 11-2-2010 Election Day: Vote! & some Op-Eds; Lagniappe: ABA Journal & comics

DJP Comment:  There still is time to vote.  Vote for the person of your choice.  But do your homework and act.  Failure to vote causes the acts of those who gave us our freedoms to be ignored and their sacrifices wasted.  Exercise your power to vote for individuals who adhere to principles and do not act like the souls in the Vestibule of Hell graphically by Dante.  He gives the fate of those opportunists who are not wanted in Heaven or Hell.  I discussed this issue in my book, “On Leadership…”.  So go and vote. Vote freedom and liberty.  Avoid coercion.
Here is an excerpt of what I said in 1985 in my outgoing speech as president of the Louisiana State Medical Society (LSMS) when I quoted Cyrano:
So, when I win some triumph, by some chance,

——- End of Excerpt

First Op-Ed: Donna Baver Rovito Op-Ed
DJP Comment:  Opinion of a physician’s wife, an Alliance member,  follows.  Donna Ravito is the bright lady I mentioned in my AMA Inaugural Address in 2003 for her outstanding reporting on the medical liability crisis in Pennsylvania.  She doesn’t grouse around the coffee pot.  She has the courage to gather the facts and act.

11/2/2010 – Liability and Health News Update ELECTION DAY EDITION – Protect your Health;

Support candidates who oppose ObamaCare

by Donna Baver Rovito

Editor, Liability and Health News UpdateAuthor, Pennsylvania‘s Disappearing Doctors

Commentary on Today’s Election

Today’s election will have a huge impact on your health.

The so-called “Patient Protection and Affordable Care Act” (PPACA) won’t accomplish any of the things its title implies and has already begun to accomplish exactly the opposite.

Insurance premiums are going up, people won’t be able to keep their plans, and quality will decline as millions of new patients are dumped into an already physician-starved system.

Access to care will suffer because a Medicaid or Medicare card is useless if patients can’t find a doctor who can afford to accept it because reimbursements don’t cover the cost of care.

The deficit will grow as hidden costs are revealed, and there will be direct or indirect “tax increases” for everyone, not just “rich” people.

America’s health care system (not the quality of its practitioners) needs reform – but in its haste to rack up a legislative win, a blatantly partisan Congress rammed bad medicine down our throats, and now the nation’s most powerful arbiter of health is a former trial lawyer lobbyist who wouldn’t know the difference between a scalpel and a bone saw.

Today, we must elect people who will roll back this disaster of social engineering and replace it with consumer protections, free market cost savings, tax fairness, and real choice and competition.  We need to elect people who support a common sense plan the American people can also support, instead of 2,700 incomprehensible pages of legislation and an estimated 50,000 pages of regulations yet to be written by an unelected Czarina of Health (HHS Secretary Kathleen Sibelius) and an unconfirmed doctor (Donald Berwick) who’s “romantic” about England’s disastrous National Health Service and favors rationing “with our eyes open.”

Pennsylvanians need to elect Pat Toomey for US Senate, Tom Corbett for Governor, and Congressional candidates who support Defunding, Repealing, and Replacing the PPACA with common sense measures that will keep the federal government out of your doctor’s exam room and your hospital’s operating room.

For a complete list of where Pennsylvania’s Congressional candidates stand on the PPACA, go here:

http://liabilityandhealthnewsupdate.blogspot.com/2010/11/vote-voter-guide-pa-governor-us-senate.html For a nationwide list of how members of Congress voted on the PPACA, go here: http://www.leagueofamericanvoters.com/CongressmenVotes.aspx And if you have questions about who supports Pennsylvania’s health in the General Assembly races, go here:

http://liabilityandhealthnewsupdate.blogspot.com/2010/11/1112010-liability-and-health-news.html

Americans need to do whatever it takes to counteract the toxic prescription forced on patients and physicians on March 23, 2010.  According to the latest Rasmussen poll, a staggering 58% of us want the PPACA repealed, while only 36% oppose repeal, despite a $3 million taxpayer funded advertising campaign, months of misinformation, demands of “compliance” and threats of “re-education” from the Czarina of Health herself.

The American people will NOT comply, Madame Secretary, and it is the Democratic Congress and administration who will be “re-educated” on Election Day.

Unapologetically,

DJP Comment:  Today, while the Nation is excited about the National Elections and correctly so, the FDA is holding a hearing today and tomorrow, November 2-3, on biologicals and biosimilars.  Hope your organization has weighed in on this important topic!  Too bad the hearing is on Election Day!  AMA has good policy about this topic.  I gave you some of the policy in a recent DJP Update.  There is lots of good AMA policy buried in the PolicyFinder.  We just need to make sure it is advocated in all of the important issues that come before regulatory agencies and Congress.  Below is my Op-Ed in the Times-Picayune online published yesterday.

The key message is:  …”they must design regulations that ensure patient safety, provide incentives for innovation and protect the ultimate independence of physicians.”
Here is my tweet with the link: www.twitter.com/DJPNEWS

DJP Op-Ed: Understanding the Challenges of Next Generation Medicine  http://tinyurl.com/27etgan #FDA #HCR #PPACA #CPPR #biologics

about 22 hours ago via web

——–

Also the direct link on Web is: http://www.nola.com/opinions/index.ssf/2010/11/understanding_the_challenges_o.html

Contributing Op-Ed columnist
The English writer Aldous Huxley once said that humanity has “an absolute and infinite capacity for taking things for granted.” I think about that as I consider the remarkable achievements we’ve made in medicine over the past century from discoveries like penicillin and insulin to the ability to transplant an organ.

The pediatric textbook that I studied from in 1963 said that childhood leukemia was 100 percent fatal. Now the majority of children with leukemia are cured! The science fiction of yesterday is frequently the cure of today. And within our grasp are the miracles of tomorrow.

Americans have access to the best health care in the world. We have it because each generation of doctors, researchers, scientists, and inventors stand on the shoulders of their predecessors. The medical miracles of today are only possible because of the time, effort, and yes, failures of the past. So to the miracles of tomorrow, like treatments and cures for horrific diseases like cancer and ALS (Lou Gehrig’s disease) will only be possible if we continue to make investments in research and discovery.

This very moment, researchers and scientists are in laboratories across the United States seeking the next great breakthrough. And many of those breakthroughs will come as next-generation biologics. Biologics are much more complex than traditional drugs. They are manufactured from living cells, using unique processes resulting in complex mixtures that are not easily characterized and virtually impossible to reproduce outside of the strict laboratory setting.

These medicines are so complex and so narrowly tailored to target specific cells in the body, small differences in their structure — which may involve molecules with hundreds of compounds — can change their effectiveness and potentially the safety of the medicine. It is because of this complexity that developing and manufacturing an identical generic version of biologics is not possible. However, after passage of the healthcare reform bill, Congress empowered the FDA to develop a pathway to approve similar, less expensive versions of biologics for patients.

Specifically, the health reform law directs the FDA to develop a system for introducing biosimilars into the market. But don’t let the name confuse the issue: The difficulty with replicating biologics cautions us to remember that similar is not the same. Unlike most traditional pharmaceutical generics, biosimilars are similar to, but not the same as the original biologic. That’s because they do not use the same cell line, production process, or raw material as the drug from which they are modeled.

Part of the FDA’s testing process must include an understanding of what scientific and technical factors the government should consider when determining whether a proposed biosimilar is “highly similar” to its brand counterparts.

That’s easy in theory, but probably much more difficult in practice. The major hurdle in biologic manufacturing is that no two molecules from different production processes can be the same. Some differences may be unimportant or trivial, others extremely important and critical to the health of the patient. The best way to understand the variances is to do clinical evaluations over time to understand precisely how a biosimilar under development may work differently than the biologic that was developed originally.

Although it is still under the radar, in early November the FDA will begin working to shape an approval process for follow-on biologics or biosimilars. As the FDA is considers this pathway, they must design regulations that ensure patient safety, provide incentives for innovation and protect the ultimate independence of physicians.

Additionally, doctors need to have confidence that the biosimilars are safe and effective for their patients. Thus, the process that the FDA undertakes needs to be thoughtful, deliberative, and science-based. The final decision on what medications ultimately are prescribed must remain between a doctor and patient — not legislators, insurers, or pharmacists. And there should be no substitution – by a pharmacist — without the treating physician’s approval.

As most will appreciate, manufacturers have to get biologic composition exactly right. Lives depend on it. And, until adequate science is in place to ensure patient safety, the standard for allowing a biosimilar to be used instead of the biologic it attempts to replicate must remain high.

Biologics are the fastest-growing segment of the pharmaceutical market and some of these promising new formulations will become the “miracle drugs” of the future. But we have to get this right. As we formulate new policies for biosimilars, we have to put the well-being and safety of patients first. That’s good policy for anyone seeking to improve America’s healthcare.••••••••

Donald Palmisano, M.D., is a former president of the American Medical Association and is the spokesperson for the Coalition to Protect Patients’ Rights.  His e-mail address is djp@donaldpalmisano.com.

———

LAGNIAPPE / DJP Comment: I have been a member of the American Bar Association since 1982, longer than a member of the AMA.  I get the ABA Journal each month.  In the November 2010 issue on page 10, there is an article entitled, “Comic-Con”.  It displays examples of the Yale exhibit called “Superheroes in Court!  Law and Comic Books”.  My favorite comic book example in the article is the cover that shows Batman and Robin in court.  The judge is the Joker and the jurors are more Jokers.  The text balloon from Batman says, “A JOKER judge and a JOKER jury!”  The text balloon from the judge says, “Yes, BATMAN, I’m giving you a FAIR TRIAL! HA-HA-HA!”  You can see the image and read the article at:

http://www.abajournal.com/magazine/article/comic-con/

I suspect some doctors feel that way with the broken medical liability system when they enter court.

—–

Stay well,

Donald

P.S. Stop by http://twitter.com/DJPNEWS and sign up for DJPNEWS to get tweet alerts that may not make it into DJP Updates.  Twitter is free and takes minutes to join.  Put email in and pick password.  Great source of breaking news and you don’t flood your email with it.  You can get free app for BlackBerry or IPhone etc and you check on tweets when you want.

Also, recent selected DJP Updates can be found at: http://donaldpalmisano.com/djp_update/
Donald J. Palmisano, MD, JD

Intrepid Resources® / The Medical Risk Manager Company

5000 West Esplanade Ave., #432Metairie, Louisiana USA 70006

504-455-5895 office

504-455-9392 fax

DJP@donaldpalmisano.com

www.donaldpalmisano.comwww.onleadership.us
This DJP Update goes to 2317 leaders in Medicine representing all of the State Medical Associations and over 100 Specialty Societies plus some other friends.You can share it with your members and it has the potential to reach 800,000 physicians.To join the list, send me an  email stating “Join DJP Update”To get off the list, state ” Remove DJP Update” in subject line.