Seton Hall Law Remembers Ted Kennedy

Senator Ted Kennedy testifying before the House Judiciary Committee, beside Peter Rodino, Chairman.

Senator Ted Kennedy with Congressman Peter Rodino, before the Judiciary Committee– of which Rodino was Chair.

Peter Rodino served as a member of the House of Representatives from 1949 to 1989–at which time he retired to a Professorship at Seton Hall Law until his death in 2005.

Senator Kennedy worked often with Peter Rodino. In her book “Fifty-Two Words My Husband Taught Me,” Joy Rodino recounts that “Upon Peter’s passing , Ted Kennedy said that during the Watergate inquiry, ‘Many of us felt that we were seeing a Founding Father in action, living the highest ideals of the Constitution. I’m sure my brother would have called him a profile in courage. I feel the same way.’”

Peter Rodino, Ted Kennedy (1978)

The Fifty-Two words that Peter Rodino so lovingly referred to so often are those of the Preamble to the Constitution. The guiding light of Peter Rodino’s career– and of our country–those Fifty-Two words are The Who, The What and The Why of the Great Document.

Included within the Preamble as reasons for creating this more perfect Union and its Constitution are “to… promote the general Welfare, and secure the blessings of Liberty to ourselves and our Posterity.”

As that is The Why, Ted Kennedy functioned as The How of that great clause in a long and fabled career in the Senate. He gave the last full measure of his life to that cause; the Flag at Seton Hall Law flies at half-mast in his honor.

Senate Compromise on Public Plan Begins to Emerge. Half-a-loaf?

The Associated Press reports that a possible compromise has emerged in the Senate with regard to the “public plan” for health insurance:

The compromise offered by Sen. Kent Conrad, D-N.D., would create health care cooperatives owned by groups of residents and small businesses, similar to how electric or other cooperatives operate.

They’d be nonprofit, and without the government involvement that troubles Republicans and business groups about the public plan options.

This attempt at compromise seeks to address the purposeful omission of the issue of a public plan option from Senator Ted Kennedy’s 615 page health reform draft bill. The draft bill, by Kennedy and Democrats from his Health, Education, Labor and Pensions Committee, was said by the LA Times to have faced “furious criticism from even moderate Republicans” when it was released on Tuesday. This despite the attempts to avoid such by the Democrats through the omission of the contentious public plan option.

Kaiser Health News describes the Kennedy Plan as follows:

The plan “would require all Americans to get medical insurance, establish complex new insurance exchanges to facilitate near-universal coverage, and dramatically step up government oversight of the insurance industry.” The plan skips over - for now - the two issues Republicans have most vocally opposed, a government-run insurance option and a mandate for businesses to insure employees. Nevertheless,  the “Republican response was sharply negative” (Levey, 6/10).

The public plan compromise proffered by Senator Conrad, at least in principle (details have yet to surface) has garnered some tentative approval. AP reports that

The chairman of the Senate Finance Committee, Sen. Max Baucus of Montana, said Wednesday the idea could be key to a bipartisan health bill. Baucus raised it in a meeting with President Barack Obama, saying later that Obama showed interest. Baucus’ Republican counterpart, Sen. Chuck Grassley of Iowa, also said the concept had potential.

“It’s a way to bridge the gap,” Baucus told reporters.

AP reports  the outline of the  Conrad compromise as follows:

Profit-making insurance companies wouldn’t run the show, but there also wouldn’t be the federal government backing that Republicans fear would eliminate fair competition with private companies. The co-ops could get federal seed money, Conrad said, but that would be the end of federal involvement. The co-ops would negotiate directly with medical providers.

FDA Scientists Say FDA is “Fundamentally [More] Broken”

Just this last week we posted that a group of nine FDA scientists from the Center for Devices and Radiological Health– which is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery-authored a letter which asserted that “The FDA is “fundamentally broken” and requires reforms.”

We wrote:

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted “John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers,” according to Kaiser.

In that post, we also called attention to the contention of the scientists that “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts.”

Noting that

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community-and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries-the managers-lack relevant scientific expertise in the pertinent subject matter-medical devices.

Apparently, the “expertise” at issue in the approval of a breast cancer imaging device is alleged to go somewhat beyond the scientific.

The New York Times reports that it has obtained various FDA emails and internal documents which underlie the scientists’ complaint and are the present subject of both an FDA internal inquiry and a congressional investigation. The emails and documents are said to provide details of the investigations which had not previously been made public.

The New York Times reports that

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The congressman is Republican Chris Shay, who lost re-election in November. A component of the imaging device was produced by a Fujifilm Medical Systems, which “is based in Stamford, Conn., the heart of Mr. Shays’s former district,” according to the NY Times.

The article also states that

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.
Read more here.

FDA Scientists Say that FDA is “Fundamentally Broken”

“The FDA is “fundamentally broken” and requires reforms, according to a letter sent to the transition team of President-elect Barack Obama by nine agency scientists, Dow Jones reports.” (Kaiser.org 1/8/08).

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted “John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers,” according to Kaiser.

A.P reports that the letter was written on FDA Center for Devices and Radiological Health letterhead; “the center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery.”

The letter reads in part as follows:

The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid. (emphasis added)

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community-and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries-the managers-lack relevant scientific expertise in the pertinent subject matter-medical devices.

The Wall Street Journal Health Blog reports that earlier today, HHS Secretary-designate Tom Daschle appeared at “a friendly hearing before the Senate’s Health, Education, Labor and Pensions Committee.” Daschle, who was one of the recipients of the FDA scientists’ letter, did not mention it in his prepared speech. Daschle did, however, state the following:

Unfortunately, there is growing concern that the FDA may have lost the confidence of the public and Congress - much to our detriment. When Americans are nervous about eating spinach or tomatoes or cantaloupes, that’s not good for our health and it is terrible for our farmers. When nearly two-thirds of Americans do not trust the FDA’s ability to ensure the safety and effectiveness of pharmaceuticals, the result is Americans may hesitate to take important medications that protect their health. This is unacceptable.

Kennedy Steps Down, Obama Steps Up EMR Spending Plan, and Study Shows Disparity in the Treatment of Women

Ted Kennedy steps down from the Senate Judiciary Committee to focus on Health Care reform.
“As chairman of the Senate Health, Education, Labor and Pensions Committee, I expect to lead a very full agenda in the next Congress, including working with President Obama to guarantee affordable health care, at long last, for every American,” said Kennedy. Read more here.

Obama announces plan to include Medicaid and Health Information Technology in stimulus package. Set for January?
Although some “congressional sources have expressed skepticism” about the ability to pass legislation of such magnitude so quickly, “top economic advisers to Obama and congressional Democrats hope to complete work on the package in January to allow Obama to sign the legislation when he takes office on Jan. 20, 2009.”
One aspect of the proposal, computerizing medical records to coordinate efforts and avoid redundancies is said to enjoy “bipartisan support in Congress,” though privacy concerns have been a matter of contention. Read more here.

A Study which examined the hospital treatment for 78,254 heart attack victims shows a disparity in treatment and results for men and women with massive heart attacks.
The study showed a greater mortality rate for women with massive heart attacks, and a lesser likelihood for women to receive recommended medicines such as aspirin within the crucial 24 hour time frame. The study also showed that women were less likely to get treatment to restore blood flow, or that it wasn’t given quickly enough. Read more here.