1. First up, the Washington Post
analyzed data released this week on Medicare payments to doctors and found “that the cost of drugs administered by doctors accounts for a growing piece of Medicare’s spending and varies widely from region to region in the United States, raising questions about whether some physicians may be misusing the pharmaceuticals. Most of the 4,000 doctors who received at least $1 million from Medicare in 2012 billed mainly for giving patients injections, infusions and other drug treatments, those records show.”
2. Eric Palmer at Fierce Pharma writes : “In case anyone missed the latest forecast, drug prices were up last year and are going to continue to grow, perhaps at double-digit rates in some cases. The outlook comes from the second pharmacy benefits management report to be released in three days, this one from CVS Caremark ($CVS) following Express Scripts’ ($ESRX) missive on Tuesday.” Palmer notes that although specialty drugs accounted for 1% of prescriptions in the United States, they “accounted for more than a quarter of total drug spending.”
3. Also making the news this week, new findings from a study by the Cochrane Collaboration that anti-influenza drugs Tamiflu and Relenza may not work as well as previously believed and may even do more harm than good. In an article at Bloomberg News, Oliver Staley quotes one of the authors of the study who said: “’There’s no credible way these drugs could prevent a pandemic’ . . . Money spent on stockpiling ‘has been thrown down the drain.’”
4. Emily Cook and David Ivill of McDermott, Will & Emery reported on recent developments related to the 340B drug pricing program which requires pharmaceutical companies to give a discount to safety net health care providers. They write: “Entities participating in or contemplating participating in the 340B Program should remain alert to 340B Program developments in the coming months and should be prepared to implement changes to 340B Program operations as necessary to remain compliant with changing requirements. All 340B stakeholders should carefully monitor the status of forthcoming proposed rules related to the 340B Program and be prepared to provide substantive comments to OPA during open comment periods.”
5. Finally, Ben Comer at the PharmExecBlog wrote a fascinating post (that quotes Seton Hall Law’s Dana Darst ) on “Project DataSphere, the newest data transparency and collaboration project with buy-in from several top pharmas and academic medical institutions,” which currently contains data sets from the comparator arms of a number of late-stage oncology trials. Among other things, Comer touches on the intriguing possibility that Project DataSphere will enable researchers to use “‘in silico’” comparator arms for new active trials”. He also discussed challenges associated with de-identification (a consultant to Project DataSphere has written “an informative de-identification strategy paper for organizations grappling with the legal implications of de-identification.”). Comer concludes with a quote from Professor Peter Doshi who “says what’s often overlooked in the charge on pharma’s data vaults is the data that’s housed at FDA. ‘They singularly hold the most data across companies, across therapeutic areas, across time. EMA is releasing data, but why is FDA not similarly opening up its archives to the public?’ asks Doshi. ‘I think the status quo for them is a more comfortable place to be than a revolution in access to data.’”
By Adino Barbarito
Mandatory vaccination, as a matter of public policy, is overwhelmingly accepted within the United States as a prerequisite for children seeking a public education. Vaccination continues to be upheld by the Supreme Court’s decision in Jacobson v. Commonwealth of Massachusetts,1 and is considered established law. Unfortunately, exemptions to mandatory vaccination remain in effect in 48 states, based upon religiousand in some cases, philosophicalobjections. While medical exemptions serve a legitimate interest, other opinion-based exemptions threaten the policy on which mandatory vaccinations are based. States that allow such exemptions should cease the practice. Furthermore, parents should pursue the possibility of tort liability against other parents who subject children to harmful diseases with their decision not to immunize their own children.
The Jacobson court recognized that the majority of the medical community, the citizens of the State, and the Massachusetts legislature all accepted that vaccines provide a necessary benefit. Since the state had a duty to protect its citizens’ welfare, it was within its rights to pass a law compelling them to be immunized, even if immunization was unattractive to a few:
. . . In every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.2
While no municipalities are currently under the threat of smallpox, they should still consider diseases like pertussis, polio, and measlesdiseases that stand to threaten communitiesas “great dangers.”3 Jacobson ruled that Massachusetts could compel its citizens to receive smallpox vaccinations, and that such compulsion was constitutionally justified under the police power afforded the states.4 In so ruling, the Supreme Court stated:
We are not prepared to hold that a minority, residing or remaining in any city or town where smallpox is prevalent, and enjoying the general protection afforded by an organized local government, may thus defy the will of its constituted authorities, acting in good faith for all, under the legislative sanction of the state.5
The Court was not prepared to let the whims of a minority refute laws that were designed for the protection of the people in good faith. The Court recognized that the mandatory smallpox vaccinations were for the benefit of the entire community, including those who may oppose them. Had the immunizations been designed to oppress the opposing minority, the Court may have decided differently.
What the Supreme Court did not do in Jacobson was prevent states from enacting statutes exempting certain individuals from vaccination. Forty-eight states have enacted statutes exempting individuals from vaccination for religious reasons. In addition, nineteen states have statutes which also exempt individuals from vaccination for “philosophical” reasons. While philosophical reasons vary by state, the most common exemptions allow a very broad array of reasons that can be deemed “philosophical.” As a result, a parent in most of these states can simply choose a “philosophical exemption” without stating any actual reason.6 Obviously no child should be compelled to receive vaccinations if she or she is predisposed to health risks as a result. It is recklessly irresponsible, however, for states to allow exemptions for any reason aside from health risks, when those exemptions create a public health danger and subject all unvaccinated children to easily preventable diseases.
It is well established that a parent may not forego lifesaving medical treatment while substituting prayer or other religious means of treatment.7 Courts have time and again recognized the fact that religion is no substitute for proper medical care, and that even a fervent belief in the power of prayer to heal does not excuse the parents and caretakers of children from their proper duty of care. Parents and guardians are required to submit to the expertise of medical professionals when a child is in imminent danger. It follows that, since we do not allow parents to substitute prayer for medicine, we should likewise not allow parents to substitute their religious beliefs for the proven vaccines that would prevent their child’s death.
In a series of cases leading directly back to the Jacobson holding, courts have established that there is no constitutional guarantee of religious exemption, and the Supreme Court, through their refusal to hear cases challenging compulsory vaccination, seems to believe the matter settled with Jacobson. The most current cases in vaccination address, and dismiss, free exercise claims when it comes to mandatory immunizations for children entering public school.8 With no constitutional hurdle, then, religious and philosophical exemptions rely solely on the discretion of the states, only two of which have refused to allow them.
The matter then becomes one of state policy. Unfortunately, states presently have little reason to compel vaccination against religious or philosophical arguments when the will of its voters does not reflect a desire for such compulsion. No state wants to enact a statute that defies most citizens’ expectations of free speech and free exercise without a particularly persuasive argument. Almost certainly, religious and anti-vaccination groups will oppose such a statute. It is a politically risky endeavor, which politicians would be loath to pursue without a strong public push in that direction. So how do concerned parents achieve such a push?