Filed under: Children's Issues, Proposed Legislation, Public Health, State Initiatives
I was stunned to learn recently that female lacrosse players, at least in my town in New Jersey, may not wear hard helmets even though male lacrosse players must wear them. This struck me as ludicrous and unfair. Both sports involve athletes running around with long sticks, hurling dense rubber balls at high speeds. It seemed to me that balls and sticks can strike players in the head and players can collide in either sport. How could we care more about preventing traumatic brain injury (TBI) in boys than in girls? I was outraged. But as it turned out, I also was a bit uninformed. It is not as clear as I thought it would be that we should require girls to wear helmets.
A common objection is that female and male lacrosse are very different sports subject to different rules and requiring different skills. Male lacrosse involves much more brute physical contact, whereas female lacrosse does not permit body checking and demands finesse. As a female senior lacrosse player explains, because girls’ lacrosse sticks have shallower pockets, girls “’have to be more skilled with our cradling, . . . [so our] game is more graceful.’” A male senior midfielder acknowledged that the girls’ “’stick skills are unbelievable’” and that “’the girls’ version is more pure.’” Some believe there is less need for helmets in girls’ lacrosse because of these differences. Moreover, there is concern that requiring girls to wear helmets will encourage girls to play more like boys, which would risk losing the valuable uniqueness of girls’ lacrosse.
As much as I want to honor female players’ pride in their skills and finesse, science should drive the policy decision whether to require girls to wear helmets. Research by Nationwide Children’s Hospital in Columbus, Ohio reveals that girls’ lacrosse has the third-highest rate of concussion among female sports, after soccer and basketball, and “its in-game rate is only about 15 percent less than the rougher male version.” But what do we know about whether helmets can reduce that risk? Not enough. Read more
Christmas has just passed and Hannukah now draws to its candled conclusion as Kwaanza begins, heralding the start of a brand new year. These times naturally encourage reflection, and with my twenty-year old prodigal daughter, Lexi, about to return to Occupy D.C. after a holiday respite, I find myself considering the positions of her compatriots who think, foremost, that the influence of big money should be removed from politics–they are championing a constitutional amendment to do so, and there are close to 300,000 signatures petitioning as a prelude to such change. It’s an ambitious and interesting thought this– what would the political landscape look like if legislators and executives voted their conscience without having to calculate the impact upon scores of their largest benefactors? What would health reform look like?
Of the Maine Clean Election Act, Matthew Edge of the Occupy Albany Political Strategy Working Group told Lehrer that “It allows for everyone running for office to essentially have the same amount of money to run. So they can win based on their ideas, and not based on just how much money they can raise. And once they’re elected, since agreeing to opt into the public funding system, the clean elections system requires them to agree not to accept any private contributions. So that seems to be — while it’s not the end all, be all — the first step.”
The Maine Clean Election Act? This is how the Act is described by the State of Maine at http://www.maine.gov/ethics/mcea/index.htm
The Maine Clean Election Act (MCEA) established a voluntary program of full public financing of political campaigns for candidates running for Governor, State Senator, and State Representative. Maine voters passed the MCEA as a citizen initiative in 1996. Candidates who choose to participate may accept very limited private contributions at the beginning of their campaigns (seed money contributions). To become eligible, candidates must demonstrate community support through collecting a minimum number of checks or money orders of $5 more made payable to the Maine Clean Election Fund (qualifying contributions). After a candidate begins to receive MCEA funds from the State, he or she cannot accept private contributions, and almost all goods and services received must be paid for with MCEA funds.
It is, notably, a voluntary program–though participation has markedly increased since the Act’s inception: legislative candidates in the year 2000 totaled 33% (116 of 350); in 2006 & 2008 that number rose to 81% (313 of 386 and 303 of 373 respectively); and in 2010 the number leveled out to 77% (295 of 385). Participation by state senate candidates is even higher, and interestingly, the participation rate of incumbents is high as well–even for those who had won in close races the previous cycle.
Equal money? Consider this from OpenSecrets.org about the 2008 elections:
In 93 percent of House of Representatives races and 94 percent of Senate races that had been decided by mid-day Nov. 5, the candidate who spent the most money ended up winning, according to a post-election analysis by the nonpartisan Center for Responsive Politics. The findings are based on candidates’ spending through Oct. 15, as reported to the Federal Election Commission.
Continuing a trend seen election cycle after election cycle, the biggest spender was victorious in 397 of 426 decided House races and 30 of 32 settled Senate races. On Election Day 2006, top spenders won 94 percent of House races and 73 percent of Senate races. In 2004, 98 percent of House seats went to the biggest spender, as did 88 percent of Senate seats.
But of course, as the Maine Ethics Commission responsible for overseeing the MCEA has recently noted,
In June 2011, the U.S. Supreme Court ruled in Arizona Free Enterprise Club’s Freedom Club PAC v. Bennett that the way Arizona awarded matching funds to candidates was unconstitutional. The Court’s decision upheld the constitutionality of publically funded campaigns but ruled that the “triggering” of matching funds based on the spending by other candidates or independent spenders was a violation of the First Amendment. Maine, like Arizona, has a full public funding program for candidates; therefore, the Supreme Court’s decision had an impact on Maine’s MCEA program.
A retooling is said to be underway for the MCEA. As it stands, matching funds have been jettisoned. According to the Maine Commission: “The loss of matching funds presents a challenge for the program. In the last four election cycles, 40% – 50% of legislative MCEA candidates received some matching funds. However, the core function of the program remains unchanged.”
Given the reality of an electorate system in which money seems to almost guarantee office, coupled with the strictures of Arizona Free Enterprise Club’s Freedom Club and Citizens United– is calling for a constitutional amendment outlandish?
When President Clinton announced his “Task Force on National Health Reform” in late January, 1993, Republicans (at least initially) felt the need to offer voters a conservative counterpoint. Their primary concern was countering the “employer mandate” proposals, which the right has long opposed as a job-killer. The stakes were raised when, for various reasons, the Task Force’s activities became a political liability for the new President. (The PBS Newshour’s website provides a useful timeline for the entire “Hillarycare” fiasco.)
Politicians on both sides recognized many of the same problems with American health insurance. But without employer mandates or government-run plans at their disposal, Republicans needed a more direct means of containing the cost of health coverage and protecting the insured from “free riders.”
Solutions from the Pauly and Heritage plans soon found their way into Republican- and Democrat-sponsored health bills-including the individual mandate that was vital to both. Lately, liberal pundits have been pushing this fact as some great dramatic irony: Republicans, some of whom are still in office today, loved the mandate back when it was an alternative to President Clinton’s proposals.
That’s a bit of an exaggeration. However much Republicans liked it, conservative legislators wanted to focus on how their bills would enable individuals to choose the insurance they wanted, rather than the consequences for failing to do so.
The “Health Equity and Access Reform Today Act of 1993,” sponsored by Republican Senator John Chafee, was probably the most thorough proposal of the bunch, and even enjoyed some bipartisan support. As has been noted, the bill shared several common elements with the ACA, and would have required all citizens and resident aliens to possess qualifying health coverage by 2005. (This is also the only bill I know of to call this requirement an “individual mandate.”)
Like the ACA, but unlike the think-tank plans or competing Republican proposals, the Chafee bill excludes those with religious objections from the mandate. This proposal didn’t so much enforce the mandate as attempt to make compliance financially attractive-only by possessing qualifying coverage could one take advantage of increased tax credits.
One rejoinder to this history lesson is that two bills without mandates, Representative Rick Santorum and Senator Phil Gramm’s “Comprehensive Family Health Access And Savings Act” and Representative Cliff Stearns and Senator Don Nickels’s “Consumer Choice Health Security Act”, were both more popular among Republicans than the Chafee bill. This is true insofar as neither bill contained a specific provision requiring Americans possess health coverage, but untrue in every other respect.
Based on the Heritage plan, the Stearns-Nickels bill terminated the employer health plan exclusion, and the medical expense and self-employed health insurance deductions. The tax credits and other benefits designed to defray the cost of health care expenses were withheld from those who failed to possess “federally qualified” coverage, as were both itemized health care deductions and even standardized deductions. The Consumer Choice Act would also have followed through with a version of the think tank proposals’ enforcement mechanism, creating state programs to provide coverage “to any individual who . . . who refuses to voluntarily purchase such insurance coverage privately.”
As with other 1990s reform bills, the Consumer Choice Act didn’t devote a specific provision to spelling out an individual mandate; yet no less an authority than the Heritage Foundation considered the bill to possess an individual mandate as per their own design. Soon after the introduction of Nickels-Stearns, Heritage scholar and conservative health care guru Robert E. Moffitt delivered an eloquent and detailed apologetic in its support. Moffitt’s reasoning would be echoed, years later, in the Government’s own defense of ACA § 1501(b).
The Santorum-Gramm bill was, at once, more draconian and less detailed than any competing proposal. Title VI of that bill stated that “Any individual with family income exceeding [100%] of the official poverty line . . . but who fails to purchase [the required] coverage . . . within 1 year of the date of the enactment of this Act, shall not be eligible for the insurance pool program under title V of this Act.” Title V established subsidized insurance pools for those with pre-existing conditions. In addition, “No provision of Federal, State, or local law shall apply that prohibits the use of any statutory procedure for the collection of unpaid debts for medical expenses incurred by [these] individuals . . . .”
In other words, under Senator Gramm’s plan, not only would you suffer the same tax disadvantages in the similarly-structured Stearns bill, but noncompliance at any point apparently nullifies whatever bankruptcy protections that would help relieve medical debt. The uninsured and underinsured would also risk the possibility that a health condition would price you out of health coverage for either a year or until you aged into Medicare (the bill is unclear as to which). That may be a valid exercise of the commerce power, but it’s also begging a closer look at the Eighth Amendment’s use of the phrase “cruel and unusual.”
There were a few conservative and libertarian criticisms of these mandate proposals, but they were comparatively tame to what we hear now. Nobody seemed to consider the individual mandate a constitutional problem of any kind. The main concern about Stearns-Nickels, it seems, was not that it required states to forcibly insure hold-outs, but that it permitted (but did not require) this by way of state-run plans. At a March, 1994, Heritage Foundation meeting, Senator Nickels promised to delete the provision. But neither Nickels nor Representative Stearns ever altered it.
This disinterest continued even after Democrats reintroduced the “Health Security Act” in July, 1994. That bill had an express individual mandate, was authored by liberal superhero Ted Kennedy, and would have issued Americans spooky-sounding “Health Security Cards.” Amazingly, at the height of Newt Gingrich’s revolution against government overreach, not a constitutional concern seems to have been raised.
At any rate, all Republican bills were left for dead by the end of 1994. Various forces (including Bill Kristol’s infamous memo) convinced the party that any compromise on health care reform would be good for President Clinton and thus bad for them. Colorado senator Hank Brown went so far as to rescind his co-sponsorship of the Chafee bill a month before the midterm election. The problem wasn’t the individual mandate, itself, but its incompatibility with the new message: there wasn’t a health care crisis in America to begin with.
 Stearns-Nickels § 131(b).
 Note, the original text reads “exceeding 200 percent of the income official poverty line . . . or who is eligible for a partial or full credit to purchase a catastrophic health insurance plan under such section.” Said tax credits are calculated as “100 percent reduced (but not below zero percent) by 1 percentage point for each 1 percentage point (or portion thereof) the qualified individual’s family income exceeds 100 percent of the income official poverty line . . . .” Thus, if your income is 101% or greater, you’re subject to the bill’s penalties.
 William Saffire, Let’s Make a Deal on Health, N.Y. Times (May 23, 1994) (available online at http://select.nytimes.com/gst/abstract.html?res=F00713FC355C0C708EDDAC0894DC494D81&scp=10&sq=safire%20health%20care%20let’s%20make%20a%20deal&st=cse); Michael D. Tanner, Health Care Reform: The Good, the Bad, and the Ugly, Cato Institute Policy Analysis No. 184 (Nov. 24, 1992) (available online at http://www.cato.org/pubs/pas/pa184.pdf); Miller, supra.
On November 30, the Food Safety Modernization Act (Senate Bill 510) passed the Senate with a 73-25 vote. Despite bipartisan support for the bill, on November 29, the Senate rejected two amendments to repeal Form 1099, a measure which likewise carries bipartisan support.
Form 1099 is an informational return required of any business that pays a vendor or contractor more than $600 in a tax year. Pursuant to the Patient Protection and Affordable Care Act, all corporations must fill out one Form 1099 for each qualifying payment relationship beginning in 2012. The tax requirement has been criticized as an onerous and burdensome requirement for small businesses.
Although both proposed amendments would have repealed the new rules, the bipartisan agreement was limited to that single issue. Democrats and Republicans have not decided how to offset the loss of approximately $20 billion over ten years that will result from repeal of the Form 1099 reporting requirements. Senate Finance Committee Chairman Max Baucus’s (D-Mont) amendment (S. Admt. 4713) did not include any budgetary offset, an omission which appears to have sunk the amendment. The Baucus amendment failed in a 44-53 vote.
The competing amendment (S. Admt. 4702) was offered by Senator Mike Johanns (R-Neb) and would likewise repeal the Form 1099 requirements. In addition, it would have offset the cost of repeal by permanently rescinding $39 billion in discretionary non-defense spending. The Johanns amendment garnered more support, but ultimately failed in a 61-35 vote (the amendment required 67 votes to pass).
According to BNA, Senators Baucus and Johanns spoke after the vote and have agreed to work together on a bipartisan solution. Senator Baucus told BNA, “We will probably need to find a revenue bill, but our desire is to get this done. We will do whatever works.”
Senator Chuck Grassley (R-Iowa), also a member of the Senate Finance Committee, stated that negotiations had begun on November 30 to solve the Form 1099 reporting problem. According to Grassley, the two main issues are (1) how to pay for the repeal and (2) what bill will serve as a legislative vehicle. “I assume there’s going to be at least one tax bill this year and if there isn’t, there’s something wrong … so some sort of tax bill has to go and you can put it on that.”
Lawmakers still have time to work out these two issues, since the Form 1099 requirements do not go into effect until 2012.
Filed under: Food and Drug Administration (FDA), Proposed Legislation
Today CNNMoney reports that drug recalls quadrupled from 426 in 2008 to a record 1,742 in 2009. The recalls have been attributed to “manufacturing lapses” in raw material quality, labeling and packaging, and contamination. Generic and over-the-counter drugs have been affected the most. CNNMoney notes that the race to put generic products on the market and the pressure to cut costs have caused drug companies to
sometimes fail to spend enough time learning how best to make the drug…. And since generic and over the counter drugs aren’t as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.
One such cost-cutting measure involves outsourcing production to foreign manufacturing sites and this measure seems to have received the most attention. (Check out fellow blogger Jae W. Joo’s post on outsourcing.)
Earlier this month, Senator Michael Bennet (D-Colorado) introduced the Drug and Safety Accountability Act of 2010 which seeks to ensure the safety and efficacy of drugs sold in America, regardless of their manufacturing location. The bill would require, among other things, that:
- manufacturers have quality management plans which the FDA can inspect;
- manufacturers maintain supply chain documentation;
- the Secretary of Health and Human Services track facilities manufacturing drugs or active ingredients for the American market; and
- the FDA be given more power to ensure drug safety, including the authority to enact mandatory recalls for batches of drugs that pose risks and to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act.
[f]or too long, the FDA has lacked the proper authority to adequately safeguard our drug supply. Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made.
A father of three, Sen. Bennet has said that the recent McNeil recall of over-the-counter children’s medicine spurred him into action.
Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson has issued a statement in response to the bill, saying that:
[t]he lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop. Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.
In addition, drug manufacturing for the U.S. market — regardless of where it occurs — is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA). These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.
The U.S. regulatory system for prescription drugs is the toughest and safest in the world….
Okay. But other people here don’t think so. (Click here to read a good opinion by Dr. Lynn Parry, Chair of the Colorado Prescription Project, on why this bill should pass.)
According to a recent Pew Prescription Project poll, less than 10% of Americans feel confident about medications manufactured in India and China. 89% of Americans support Congressional action to introduce new drug safety measures. How many of those people realize that approximately 80% of the materials used to make or package drugs sold in America comes from foreign sources? I didn’t, but then, is such high a percentage really that surprising?
Reading through the CNNMoney report, I was reminded a little of a scene from a seventh season episode of Friends:
Phoebe: It’s amazing! My headache is completely gone! What are those pills called?
Phoebe: Oh, I love you, Hexadrin! Oh look! It comes with a story!
Monica: No, Phoebe, those are, like, the side effects and stuff.
Phoebe: Say what?
Monica: You know, the possible side effects.
Phoebe: Oh my God! Dizziness, nervousness, drowsiness, facial swelling, nausea, headache… Headache! Vomiting, stomach bleeding, liver damage! Now, okay, I don’t recall any of this coming up when you gave me these little death capsules! Oh, I’m sorry, extra-strength death capsules!
Admittedly, the scene concerns how potential side effects can be worse than the problem being treated (and that’s a whole other blog post). Yet it’s also a reminder of how we can forget about the other potential hazards of these potent drugs, delivered in easy-to-swallow capsules/tablets/liquids, if there are quality control or other manufacturing issues. It’s as easy to forget as it is to pop them, well, like candy.