Latest Drugwonks' Blog
In the case of the Commerce Clause and whether the government can compel people to purchase health insurance the Court is, following the reasoning of Judge Silberman, The Court will look at " four factors in determining whether legislation represents a valid effort to use the Commerce Clause power to regulate activities that substantially affect interstate commerce. I am paraphrasing from the Supreme Court decision to invalidate the Gun-Free School Zones Act of 1990 on the grounds is exceeded the authority of Congress to regulate under the Commerce Clause:
Whether the activity was non-economic as opposed to economic activity; previous cases involved economic activity.
Whether the purchase of insurance is an interstate commerce activity
Whether there had been Congressional findings of an economic link between not purchasing insurance, the economy and/health care costs at any point in time
Whether there is a link between regulated activity or inactivity and interstate commerce. http://en.wikipedia.org/wiki/United_States_v._Lopez
The third factor is the one that Silberman focused on. And like other judges who did so they bought the argument that without a mandate people who didn't have insurance would add costs to the system at some point and therefore not buying coverage is, broadly defined, an economy activity. However, one aspect of the Lopez case not always considered in current discussions. The Court of Appeals that ruled the Gun Free Act unconstitutional found the findings and evidence presented before Congress to justify the passage of the Act pursuant to the federal Commerce Clause power was simply insufficient to uphold the Act. http://en.wikipedia.org/wiki/United_States_v._Lopez#cite_note-9
I don't know if the states bringing suit against the federal government have raised or will raise this argument. I don't know if doing so is a plausible legal strategy. But it would seem pretty easy to poke holes in the claim that the lack of a mandate is responsible for rising health care costs and to argue that the findings and evidence presented by Congress are not enough to support the health care law.
It's probably a point worth pursuing for the following reason: I still believe that whatever the Court decides it won't be to the advantage of the proponents of the law and President Obama in particular. If the Court overturns the mandate the administration has made it clear that the rest of the expansion of government power can go on, as well it can. And if the Court upholds the law, it will re-ignite resentment and then some. Whatever happens, Obamacare will become an important campaign issue, as will it's repeal or wholesale revision. That is as it should be.
The Supreme Court said on Monday it would consider the challenge to last year's health care reform law, setting up a major ruling on the Obama administration's signature legislative achievement just months before the presidential election.
The case is likely to be heard in March, meaning that a final decision is likely at the end of the Court’s term, in June.
Apparently in recognition of the complexity of the issues presented by the cases, the Court has asked for an unusual amount of time for oral arguments. The order said the court would listen to five and a half hours of arguments—a rare departure from its usual practice of allocating an hour to hear a case.
The Court has asked lawyers to answer four legal questions about the law in their briefs, signaling that it will issue rulings on each of them.
Read more here.
The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) proposed by Senator Kay Hagen (D,NC) would create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they provide meaningful advances in the treatment of an unmet serious or life threatening condition. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries.
TREAT would permit progressive approval based on data "reasonably likely" to predict clinical benefit, the standard currently used for accelerated approval. Unlike accelerated approval, drugs could receive progressive approval without data from a surrogate endpoint. Exceptional approval could be granted when the data necessary to satisfy the standard for approval "cannot ethically, feasibly or practicably be generated." would also relax conflict of interest restrictions for advisory committee members, create a fixed term for the FDA commissioner, and revise FDA's mission statement to emphasize the promotion of biomedical innovation.
The draft bill can be found here.
http://washingtonexaminer.com/opinion/columnists/2011/11/david-salzmans-valiant-fight-what-truly-matters
David Salzman's valiant fight for what truly matters
By: Diana Furchtgott-Roth | 11/10/11 8:05 PM
It was December 2006, just before Christmas, when my friend David Salzman called. "I have bile duct cancer, and they've given me only three months to live."
That was almost five years ago. At 1 am on Saturday morning, David, age 53, a Maryland entrepreneur, succumbed to an infection, dying at Johns Hopkins Hospital in Baltimore, with his mother, Nancy Salzman, next to him.
He was one of the longest-surviving patients with bile duct cancer. As well as his mother, he leaves his wife, Beth Kevles; two children, Michael, 16, and Joel, 14; and his brothers, Andy and Jimmy.
For David, our health insurance system worked. As an entrepreneur, he had small-business insurance through Blue Cross Blue Shield. It didn't drop him and never questioned his care. David had only praise for Blue Cross.
I met David in Washington, D.C., in 1986. With two degrees in physics, a B.S. from Yale and a Ph.D, from the University of Chicago, he could have taken the usual academic route. Instead, he founded startups to develop new products.
One of his first companies was Polychip, where he pioneered proximity chip-to-chip communication, which dramatically increases the data rate between chips by stacking them on top of each other.
David sold that patent to Sun Microsystems, later bought by Oracle, which now has a government contract using the technology to develop a new generation of supercomputers.
Another of his companies, LightSpin Technologies, uses new ways to manipulate, detect, and generate light. When David died, he was developing ways to use light waves to find land mines. He considered this vital because of the danger posed by hidden mines.
One of his partners, Eric Harmon, told me, "You shake the ground with a loud noise, and then use the pattern of the sound waves to find the land mines."
Right until his death, David was active in community meetings about the new Montgomery County rail line, the Purple Line. He was intensely concerned with the way politics were overcoming science, and showed how studies justifying the project were artificially inflating ridership and energy savings and minimizing the noise levels.
David was more than just a scientist, he was a modern Renaissance man, able to enjoy literature, opera, and politics with equal knowledge and gusto. That's why my husband and I asked him to be the godfather to our third son, Godfrey, hoping a little magic would rub off.
"There wasn't anything that could be learned that David didn't want to learn," his mother told me on Wednesday.
This extended to his cancer treatments. David's college buddy, Phil Schiff, organized a team of friends to drive David to Hopkins for his weekly treatments so that Beth could spend more time with the boys. I was honored to be on the team.
At the hospital, David would go over the printouts of the blood tests, questioning the nurses and technicians. He chose the most aggressive treatments possible, overcoming pain and side effects, anything to have more time with his family.
Thoughts of his family spurred him on. David kept going by trying to survive until specific events such as Michael's bar mitzvah, Joel's bar mitzvah, and then, the final goal, Michael's 16th birthday on Sept. 23.
Beth told me on Thursday, "David did not want to be remembered for his cancer. Cancer was what he had, not what he was." On the drives to Hopkins we'd talk not about cancer treatments, but about how our various children were doing in school and what they would do over the summer.
Because, in the end, that's what matters.
The Digital Health Council (DHC) was created to serve as the collective public voice and provide a national public forum for the discussion of current and future issues relevant to digital and electronic marketing of healthcare products and services. I am honored to serve on the Council’s advisory board.
On October 13, 2011 at the Marketing to the Digital Consumer conference in Fairfield, NJ (hosted by DTC Perspectives), I participated on a panel with some of my fellow DHC advisory board members. My fellow panelists were:
Mark Bard, Co-founder of the Digital Health Coalition
Joan Mikardos, Senior Director, Digital Center of Excellence, Sanofi
Jeremy Shane, President and Chief Operating Officer, HealthCentral
Jay Goldman, VP Strategy, Klick
Gautam Gulati, Chief Medical Officer, Physicians Interactive Holdings
My opening comments commenced as follows:
In my opinion, social media must be viewed primarily as a way to advance public education, public health, adherence, compliance – all the things we say are really important – but always come second to selling product. We’re not going to advance the use of social media as long as we’re stuck in “sell” mode. When we move towards advancing the public health we begin to revive the mission of the pharmaceutical industry.
A transcribed version of the panel discussion has been created as a white paper and can be found here. No punches were pulled.
The National Federation of Independent Business is announcing a new report this morning that says the health insurance premium tax (levied on insurance plans) will cut as many as 249,000 jobs in the private sector by 2021 and cause a loss of $18 billion to $30 billion in sales. The drop would be a result of rising premium costs for employers and consumers. Just last week America's Health Insurance Plans released a similar report that said the tax would increase premiums by as much as 3.7 percent. The White House pushed back on the AHIP report and said it ignored "provisions that will increase transparency and bring costs down."
Read the NFIB report here.
Kansas Gov. Sam Brownback announced a major overhaul of the state’s Medicaid program today, which would put nearly all Medicaid recipients into private, managed-care plans. While low-income families are currently in such plans, elderly and disabled Kansans receive care through a fee-for-service system.
The state has drafted a request for proposals from private contractors willing to provide comprehensive health, mental health and long-term health care services at a fixed rate per person. State officials say they expect to select three vendors, who will compete for clients.
At a news conference today, Lt. Gov. Jeff Colyer, a physician and the administration’s point man on the Medicaid reform effort, predicted the changes could slow the growth in Medicaid spending by nearly one percent a year. That would save the state more than $350 million over the next five years and would save the federal government $500 million at the same time.
Read the full story here.
A new report in the Chicago Sun-Times raises an important question in the looming debate over generic interchangeability – the non-active ingredients in pharmaceuticals.
Just as there are bioeqivalance issues between innovator and generics – so too are there important differences between generics of the same molecule. And an important issue in both cases is the variety of fillers, colors and additives in these products that have nothing to do with the reason it is prescribed but can have unintended and undiagnosed consequences that can range from stomach pains to headaches to hyperactivity.
“It’s frequently overlooked by medical professionals and patients because, when we prescribe medication, we’re prescribing the active ingredient,” said Dr. John Saran, who specializes in internal medicine with Edward Medical Group. “(But) there may be 15 other things in there.”
While patients generally are asked if they have allergies to any medications, the allergy refers to the drug, not necessarily the fillers in it.
For instance, lactose is a common filler in pills and capsules. If a patient is lactose intolerant, the patient might believe they cannot tolerate the drug, when in fact, it is the filler that is causing cramping. Neither the doctor nor the patient may be aware that the pill contained lactose because, according to Saran, many times the additives and filler information are not included on the handout from the pharmacy.
According to the Sun-Times report, “Common additives … can lead to asthma attacks, anaphylaxis, runny nose and adversely affect children with learning disorders. Artificial sweeteners can affect those who have hyperactivity. Vegans may not want capsules because they are gelatin based. Even dye-free versions of medicine may still contain preservatives that can cause reactions. Children’s medications are especially a problem because they are flavored and colored to make them more palatable."
As if adverse event reporting wasn’t tough enough already.
According to BioCentury, Lisa Barclay has replaced Molly Muldoon as chief of staff for Commissioner Margaret Hamburg. Barclay, a partner at the law firm of Zuckerman Spaeder, worked at FDA in the 1990s in the Commissioner's Office of Policy.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
