New York City’s Attempt to Crackdown on Prescription Drug Abuse Through the Emergency Room

On January 10, 2013, New York City Mayor Michael Bloomberg announced[1] that the City’s eleven public hospitals will comply with voluntary emergency room guidelines aimed at stemming the abuse of prescription opioid painkillers.

The New York City Emergency Department Discharge Opioid Prescribing Guidelines (“Guidelines”) highlight that the federal Emergency Medical Treatment and Active Labor Act (“EMTALA”) “does not require the use of opioid analgesics to treat pain.”   Given their risks, “[o]pioid analgesics should not be considered as the primary approach to pain management in discharge planning for patients.”

According to the Guidelines, only when deemed professionally appropriate to prescribe these drugs, emergency department (“ED”) prescribers should prescribe no more than a short course of short-acting opioid analgesics, such as hydrocodone (e.g., Vicodin), immediate-release oxycodone (e.g., Percocet), and hydromorphone (e.g., Dilaudid), for acute pain.  The Guidelines define “short course” as no more than three days’ worth of medication for most patients.

ED providers should altogether avoid prescribing long-acting or extended release opioid analgesics, like OxyContin, Methadone, and Duragesic patches, however, because they “are not indicated in the management of acute or intermittent pain.”

The Guidelines further recommend that EDs as a matter of policy refuse to replace prescriptions for opioid analgesics that are claimed to be lost, stolen, or destroyed.  In rare instances, it may be reasonable to dispense a single dose of the medication from the ED, but only where the ED physician “confirmed the need directly with the patient’s physician.”

An article in the New York Times reports some critics’ concerns that the Guidelines will prevent doctors from providing care to poor and uninsured patients who may use EDs as their primary source of medical care.  In addition, Dr. Alex Rosenau, president-elect of the American College of Emergency Physicians, is quoted as criticizing the Guidelines for preventing him from being a professional and using his judgment.

In fairness to the Bloomberg Administration, the Guidelines expressly note that they are not intended to apply to “patients in palliative care programs or with cancer pain.”    They further recognize that they “do not replace clinical judgment in the appropriate care of patients nor are they intended to provide guidance on the management of patients while they are in the ED.”

This suggests doctors retain the ability to exercise their professional judgment to deviate from the Guidelines in appropriate cases. Indeed, Dr. Rosenau apparently does not speak for the New York State Chapter of the American College of Emergency Physicians, which endorses the Guidelines, according to Bloomberg’s press release.

But implicit in the Guidelines is the assumption that appropriate prescribers are available to provide palliative care or substance abuse treatment to patients with needs that demand more than the Guidelines permit.

The number of uninsured Americans remains significant, even with the Affordable Care Act’s reforms.  Many individuals with health insurance, moreover, have difficulty finding specialists who participate in their plans or may have to wait weeks or months for an available appointment.  How are ED prescribers supposed to know which patients will be able to secure a timely follow-up appointment and which ones require ED discretion?

Another potential concern with the Guidelines is how they may impact ED use by patients seeking opioid prescriptions.

It is possible that the Guidelines will drive up demand for painkillers from ED services at private emergency rooms in New York City and public or private emergency rooms in areas bordering New York City that are not bound by the Guidelines.   As the New York Times article reports, although the City cannot impose the Guidelines on its 50 or so private hospitals, some already have agreed to adopt them, including NYU Langhone Medical Center and Maimonides Medical Center.   If they don’t, it’s reasonable to predict demand for pain medications may spike at these facilities, which effect would not address the underlying problem but instead would just shift its locus.

ED use could even increase at hospitals electing to comply with the Guidelines.  A patient who previously obtained a ten-day dosage of pain medication from a single ED visit, for example, might more than triple her ED use because now she may only obtain a three-day dosage in each visit.  This risks exacerbating the ED high utilizer problem that so many current reforms aim to reduce.

There also seem to be holes in New York’s prescription monitoring program that limit its value as a tool to help ED physicians decide how to exercise their discretion.

For one, although the Guidelines recognize that prescribers can “access the New York State Controlled Substance Information (CSI) on Dispensed Prescriptions Program for information on patients’ controlled substance prescription history,” the Guidelines do not require ED prescribers to do so.

Even if ED physicians access the database, current law only requires pharmacists to update the registry every two weeks.  While this may identify historical patterns of abuse, the reporting delay severely hampers the ability of physicians to timely identify concurrent or more recent doctor shopping.

Effective August 27, 2013, New York’s database arguably should become more valuable as a tool for identifying drug seeking behavior.   Pursuant to Public Health Law Section 3343-a, prescribers in New York will have to check the database before prescribing controlled substances, and pharmacists will have to update the database in real time.

But importantly, subparagraph (2)(a)(v) of this law exempts ED prescribers from the requirement to check the database prior to prescribing controlled substances as long as the prescription does not exceed a five day supply, which the Guidelines generally prohibit.   New York’s registry also will not contain information about prescribing in other states, such as bordering New Jersey and Connecticut.

Although not a substantive criticism of the Guidelines, it also is interesting to note the potential tension between this initiative and news that New York City’s public hospitals are negotiating to experiment with performance pay.  As a recent article in Forbes chronicled, there is evidence that doctors overprescribe medications, including powerful narcotics, to help secure higher patient satisfaction scores and, in turn, greater compensation.  If this performance plan goes through, it will be worth watching how ED doctors in New York City public hospitals balance the need to comply with the Guidelines with their desire to maximize their compensation.

Mayor Bloomberg rather cavalierly dismissed critics’ concerns about the Guidelines in his weekly radio show, reportedly responding, “[S]o you didn’t get enough painkillers and you did have to suffer a little bit. The other side of the coin is people are dying and there’s nothing perfect …. There’s nothing that you can possibly do where somebody isn’t going to suffer, and it’s always the same group [claiming], ‘Everybody is heartless.’ Come on, this is a very big problem.”

Certainly, prescription drug abuse is a very big problem. But that does not mean the Guidelines are the best we can do.  We must continue to evaluate and revise our reform efforts.

Bloomberg’s announcement also touted the creation of NYC RxStat, which is a joint effort of the Mayor’s Task Force on Prescription Painkiller Abuse and the New York/New Jersey High Intensity Drug Trafficking Areas (HIDTA) Program to “leverage relevant public health and public safety data in support of monitoring and combating the problem of prescription painkiller abuse.”

Undoubtedly it is critical to bring together city, state, and federal agencies to address this cross-border problem by sharing data, assessing trends, and evaluating strategies to reduce prescription drug abuse.  I hope part of its charge will be evaluating the Guidelines — and similar efforts in places like Seattle, Ohio, and Milwaukee — to address potential flaws and to make more effective use of prescription monitoring programs without denying appropriate care to patients in need.

Recent Research Regarding Potential Best Practices for Prescription Drug Monitoring Programs

As this blog has chronicled (see here and here), New Jersey has begun implementing the 2008 legislation that authorized creation of a Prescription Drug Monitoring Program (“PMP” or “PDMP”).  Although New Jersey’s PMP database has been collecting data for more than a year, the State has not yet issued implementing regulations to flesh out the details of the program beyond what the statute requires, such as the specific information and in what time frames pharmacies must make reports and the scope of interoperability agreements with other States.   The Prescription Drug Monitoring Program Center of Excellence at the Heller School for Social Policy and Management at Brandeis University released “Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices” on September 20, 2012, which provides much for the State to consider as it moves forward.

As its title suggests, this White Paper aims to identify potential PDMP best practices, evaluate the evidence supporting labeling these as best practices, and survey the extent to which PDMPs throughout the country have adopted them.

After tracing PDMP development  from its early roots  in the 1980s and summarizing evidence suggesting that PDMPs are effective in improving the prescribing, and addressing the abuse, of controlled substances, the report identifies thirty-five potential best practices for these programs, including:

1.       Standardizing data fields and formats across PDMPs to improve the comprehensiveness of data, comparability of data across states, and ease of integration with prescription information collected by potential PDMP collaborators, like Medicaid, the Indian Health Service, the Department of Veterans Affairs, and Department of Defense.

2.       Reducing data collection intervals and moving toward real-time data collection to improve the utility of information collected for clinical practice and drug diversion investigations.

3.       Integrating electronic prescribing with PDMP data collection to facilitate communication with electronic prescribers and facilitate monitoring of prescriptions as they are being issued as well as before and after they are dispensed.

4.       Linking records to permit reliable identification of individuals (patients or prescribers), which is necessary for accurate analysis of trends and potential questionable behavior.

5.       Determining validated and standardized criteria for possible questionable activity.

6.       Conducting epidemiological analyses for use in surveillance, early warning, evaluation, and prevention to identify trends in prescribing and questionable behavior, which may inform public health objectives.

7.       Providing continuous online access and automated reports to authorized users to encourage utilization.

8.       Integrating PDMP reports with health information exchanges, electronic health records, and pharmacy dispensing systems to make it more efficient to access data.

9.       Sending unsolicited reports and alerts to appropriate users based on data suggesting potentially questionable activity, such as doctor shopping or inappropriate prescribing.

10.   Enacting and implementing interstate data sharing among PDMPs to address interstate diversion and doctor-shopping.

11.   Securing funding independent of economic downturns, conflicts of interest, public policy changes, and changes in PDMP policies, such as from grants, licensing fees, general revenue, board funds, settlements, insurance fees, private donations, and asset forfeiture funds.

12.   Conducting periodic review of PDMP performance to ensure efficient operations and to identify opportunities for improvement.

The authors noted, however, that good research evidence is not available to support the value of the vast majority of these potential best practices because “research in this area is scarce to nonexistent.”  Thus, they suggested a prioritized research agenda with the goal of strengthening the evidence base for practices they believe have the greatest potential to enhance effectiveness of PMP databases and that can be studied using scientific techniques like randomized controlled trials or observational studies with comparison groups.  Specifically, the report recommends focusing research and development on (a) data collection and data quality; (b) linking records to identify unique individuals; (c) unsolicited reporting and alerts; (d) valid and reliable criteria for questionable activity; (e) medical provider education, enrollment, and use of PDMP data, which includes the question of whether to require providers and dispensers to access the database; and (f) extending PDMP linkages to public health and safety.

The report makes valuable recommendations that will help guide policy makers as these programs continue to evolve.  Despite its many strengths, however, the report gives short shrift to a critical area for ongoing monitoring — whether PMPs have a chilling effect that makes it more difficult for patients in pain to obtain appropriate, palliative care.    Although this concern is mentioned in passing in various places in the report, it is not expressly incorporated into the authors’ conceptualization of how we should evaluate PDMP effectiveness.  Indeed, it is dismissed as potentially overblown even though Appendix A to the report notes that twenty-three percent of Virginia doctors in a 2005 survey who believed their prescribing was being more closely monitored because of the PDMP “reported it had a negative impact on their ability to manage patients’ pain.”   Admittedly, other studies summarized in the appendix found no chilling effect.  But given the article’s critique of most studies as lacking empirical rigor and its call for more scientific study, it seems prudent to encourage empirical research to evaluate this concern.  Recognizing that “an explicit goal of PDMPs is supporting access to controlled substances for legitimate medical use,” an August 20, 2012 [fee required to access] report from the Congressional Research Service suggested that “[a]ssessments of effectiveness may also take into consideration potential unintended consequences of PDMPs, such as limiting access to medications for legitimate use . . . .”  (Although the August 20, 2012 CRS report does not appear to be available without charge on the internet, a July 10, 2012 version of this report is available here.)

With this caveat in mind, the Brandeis report undoubtedly is a valuable resource to policy makers and academics as they consider how to make the most appropriate and efficient use of PMPs.  New Jersey can build on this knowledge base as it decides how to make use of its PMP.  As the White Paper’s laundry list of potential best practices makes clear, the State has a plethora of options to research and consider.  If New Jersey adopts the proposed regulations permitting electronic prescribing of controlled substances, for example, it should consider how it can integrate electronic CDS prescription records with its PMP.  Given the statutory authorization to share data with other States, New Jersey also can learn from the experiences of States that are adopting standardized data formats and implementing interoperability agreements with other States.

The State also should evaluate the evidence that unsolicited reports increase the effectiveness of PMPs and whether legislation and/or regulations would be required to authorize their use in New Jersey.   A related issue is what criteria to adopt to define potentially questionable behavior that would trigger an unsolicited report, which must balance the risks of false negative and false positive reports.

Similarly, the State may wish to explore the advantages and costs of moving toward a real-time database rather than its current design that requires dispensers to report at least twice per month.  The Alliance of States with Prescription Monitoring Programs’ PMP Model Act 2010 Revision recommends that pharmacies submit data no more than seven days from when the script was dispensed, and Oklahoma is implementing real time reporting.  (A recent study published in CMAJ found a 32.8% relative reduction among residents receiving social assistance in inappropriate prescriptions for opioids and a 48.6% reduction in inappropriate prescriptions for benzodiazepines within thirty months of implementation of a Canadian centralized database containing real-time prescription data.)

New Jersey also could study the experiences of various states like New York that are requiring certain prescribers and dispensers to register with the State’s PDMP and, in some cases, to check the database before authorizing or dispensing prescriptions for CDS.  A research study underway in Utah may shed some light on whether mandating provider participation in PDMPs improves effectiveness.

In general, the State may wish to research how to strike the appropriate balance between educating prescribers, dispensers, and patients of the risks of prescription abuse and punishing those involved with diversion or abuse.

Because virtually all of these policy choices also involve substantial costs to research and implement, New Jersey might wish to pursue alternative sources of funding, such as grants available through the federal Harold Rogers Prescription Drug Monitoring Program or the National Association of State Controlled Substances Authorities.

Sunder on Patents and Access to Medicine

Last week, the blog Concurring Opinions featured a symposium on Madhavi Sunder’s new book, From Goods to a Good Life: Intellectual Property and Global Justice. A chapter relevant to health law scholars is available online, here.  The chapter focuses on access to drugs in less developed countries (LDCs), and makes the following case:

Not too long ago, an HIV-positive diagnosis was tantamount to a death sentence — for people in the East and the West, in the South and the North. The drug companies that perfected the antiretroviral therapies invested princely sums to find these miracle cures. To justify their investment, they rely on the promise of a patent . . . . Thus patents have saved countless lives. But this structure has its limits. Indeed, the evidence is mounting that in crucial ways patents fail to promote the health of people in the developing world, and in some cases in the developed world as well.

The chapter begins by telling the moving story of Thembisa Mkhosana, one of thousands of South Africans who cannot afford the third-line antiretroviral treatments needed to survive AIDS.   “My blood test results have worsened dramatically,” Mkhosana told a reporter, “And now I suddenly have fever and am in pain. I’m really worried.”  ”I know that I’m going to die,” she said, but “who is going to look after my children?”  Her story appears in this video.

Mkhosana’s plight raises difficult interpretive issues.  Is she “collateral damage” from a patent system that depends on the strict rules that deny her access to the medicine she needs? Or is this an entirely avoidable tragedy, a consequence of misapplied and misinterpreted laws?  Sunder makes the case for the latter view very convincingly, while providing a compact and accessible account of the development of international patent policy over the past 20 years.

Sunder acknowledges the importance of patent law to incentivizing the development of new drugs. However, as she wisely notes, one can’t squeeze blood from a stone, however important the “skin in the game” ideology has become to advocates of “free-market” healthcare.  According to Sunder, “creation of generic drug markets for the poor ought not significantly impact the bottom line of Big Pharma, which derives only 5 to 7 percent of its profits from this part of the world.”  It may well be possible to make up for some of that figure by cutting back on promotional budgets in the developed world. It’s also a rather trivial figure compared to tax avoided or evaded on the tens of trillions now hidden away in tax havens.

On the other hand, Big Pharma has a number of justifications and excuses for aggressive assertion of their patents. Spokesmen aver that they are only concerned about what would happen to their profit margins if drugs circulated in an uncontrolled manner. They claim that, if poor countries are permitted to manufacture vast quantities of their drugs, those countries may sell them on the black or grey markets. That, in turn, would reduce the return on such drugs in the developed world, leaving less money for research in the future. Sunder responds that, “The grey-markets concern is a valid one—but . . .the World Trade Organization has begun to craft creative solutions to this problem (requiring generic drugs made for developing world markets to be distinctively labeled, for example).”  As surveillance of both people and goods is better perfected by state security apparatuses and RFID technology, the grey market concern should also become more technologically manageable, enabling finer-grained and more effective price discrimination.

Access to drugs is a key area where ordinary markets simply can’t be expected to achieve humane and rational results.  In 2008, the purchasing power of the average American dog was higher than that of forty percent of the world’s population. Given the extensive extant involvement of the U.S. government both in the domestic pharmaceutical industry and in the international negotiations determining its powers and duties abroad, there is a special moral obligation for U.S. citizens and politicians to assure the widespread and equitable distribution of lifesaving drugs. As Sunder states:

Economists call the millions of people who need a drug but cannot afford it “dead weight loss.” But the millions who die needlessly because of the patent system—a number that some scholars calculate as nine million in the developing world annually—are more than an inefficiency in the system. . . . We must both adopt alternative mechanisms for developing and distributing medicines to the poor (including prizes), and fully support the use of compulsory licenses by developing countries to treat their sick poor. Patent law cannot draw the line at rectifying market failure. Our law must contend with moral failure as well.

Sunder’s eloquent case for access to drugs commends respect and admiration for the Health Impact Fund, Knowledge Ecology International, Medecins sans Frontieres, and other groups for trying to close this gap.

X-Posted at Bill of Health.

Childhood Cancer: Pushing and Pulling Against a Powerful Foe

Since September is National Childhood Cancer Awareness Month –a calendar of events can be found here– a review of relevant recent and pending federal legislation seemed appropriate.  The Food and Drug Administration Safety and Innovation Act (FDASIA), which the President signed into law on July 9, 2012, included a number of provisions that it is hoped will speed development of drugs to treat childhood cancers and other rare diseases.  As Peter L. Saltonstall, who heads up the National Organization for Rare Disorders (NORD), explains here, the central purpose of the FDASIA was to reauthorize the Prescription Drug User Fee Act, but several separately-introduced bills “of particular importance to rare disease patients and supported by NORD” were incorporated into it.  These included the Creating Hope Act, which was powerfully advocated for by Kids v Cancer and the bi-partisan Congressional Childhood Cancer Caucus.

The Creating Hope Act expands the FDA’s priority review voucher (PRV) program– which was passed to incentivize the development of treatments for neglected tropical diseases, malaria, and tuberculosis– to cover rare pediatric diseases, including childhood cancers.  Under the program, “[t]he [FDA] shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the [FDA] of such rare pediatric disease application.”  The fully-transferable voucher can be redeemed for review of–and action on–another new drug application within just six months.  In an influential 2006 article in Health Affairs, David Ridley and colleagues estimated that if a “voucher speeds FDA approval by a year, it could increase the present value of sales of a blockbuster drug by more than $300 million.”

While a voucher worth as much as $300 million would seem to add up to an attractive “pull” mechanism, the PRV program for neglected tropical diseases has, unfortunately, not lived up to expectations.  Only one company, Novartis, has received a PRV, for an anti-malaria drug which was already approved and marketed outside the United States.  Writing at The Incidental Economist earlier this year, Kevin Outterson characterized the PRV program as “unsuccessful” and its extension to rare pediatric diseases as “disappointing.”  More promising, Professor Outterson suggests, are “push” mechanisms like the Innovative Medicines Initiative (IMI) in Europe, described here, which will, among other things, funnel $738 million to antibiotics researchers between now and 2020, with the initial goals of “building and training networks of researchers, facilitating and increasing the exchange of research data, and improving the efficiency of clinical trials on new antibiotics through better laboratory tests and better trial design” and the long-term goal of “speed[ing] up the development of much-needed antimicrobial drugs.”  Notably, the IMI was established with $1.23 billion of European Union funds and an impressive $1.23 billion of “mainly in kind contributions (consisting mostly of research activities)” from the European Federation of Pharmaceutical Industries.

The National Pediatric Research Network Act of 2012, which is currently pending in the House and Senate, bears some similarities to the IMI’s antimicrobial drug development effort.  The Act would appropriate government funds to support the establishment and operation of a network of pediatric research consortia that would conduct “basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research” and “train[] researchers in pediatric research techniques.”  The Act provides that “an appropriate number of such awards” must be awarded to consortia that, among other things, agree to “conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions[.]”

Childhood cancers are not specifically mentioned in the text of the National Pediatric Research Network Act, however, and, should it pass, the Network it establishes is likely to focus on other rare pediatric diseases.  An existing network, the Children’s Oncology Group (COG), which is principally supported by the National Cancer Institute, “unites more than 8,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer.”  COG “has nearly 100 active clinical trials open at any given time … include[ing] front-line treatment for many types of childhood cancers, studies aimed at determining the underlying biology of these diseases, and trials involving new and emerging treatments, supportive care, and survivorship.”  The existence and success of COG — it’s “research has turned children’s cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today,” although it has suffered from budget cuts in recent years–likely explains why advocates have turned their attention to pull mechanisms like the Creating Hope Act that build on existing incentives aimed at increasing industry investment in drug research.

Another model for increasing industry involvement is to require it.  This could perhaps be described as a strong pull mechanism.  The Pediatric Research Equity Act (PREA) takes this approach, requiring, with some exceptions, that a sponsor of a new drug application study that drug in children.  FDASIA, as the FDA summarizes here, makes PREA “permanent — no longer subject to reauthorization every five years[,] … requires earlier pediatric study plan submission by drug manufacturers subject to PREA and gives FDA new authority to help ensure PREA requirements are addressed in a more timely fashion.”  PREA, though, has not worked to generate research into pediatric cancer treatments, and the FDASIA reforms will not change that.  In remarks delivered at the 2^nd Annual Childhood Cancer Summit in September 2011, Dr. Peter Adamson, the Chair of the Children’s Oncology Group, explained that an exception to PREA’s requirements “can be granted for most new cancer drugs, as the common cancers observed in adults essentially do not occur in children.”

Of course, industry involvement could increase though profit-driven activity without additional pushes or pulls from government.  Childhood cancers have not, thus far, been an industry focus.  In the past twenty years, the FDA has approved just two drugs, clofarabine and erwinaze, to treat pediatric-specific cancers.  It was not until this past August that the agency approved the first “pediatric-specific dosage form” of a cancer-fighting drug, everolimus.  A story reported in Fortune’s September 3, 2012 issue entitled Rare Diseases Mean Big Profits (an online version is available here), suggests that there may be hope that the pace of development will accelerate.  According to Fortune:

Wall Street skews bullish on Alexion[, a specialty pharmaceutical company that developed and sells the drug Soliris which is used to treat two rare disorders,] and its peers in the ultra-rare-disease market.  With Pfizer and other big pharma companies facing devastating revenue drops as blockbuster drugs like Lipitor go off patent, niche players like Alexion look good because of their monopoly pricing power.

Soliris, Fortune reports, costs “around $400,000 per patient per year.”  There may be, then, cause for hope that in the coming years the private sector will increase its investment in the surpassingly important search for treatments for childhood cancers and other rare pediatric diseases.  I welcome your thoughts.

Electronic CDS Prescriptions Proposed in New Jersey

More than two years ago, the Federal Drug Enforcement Administration (DEA) issued interim final regulations permitting practitioners to issue and pharmacists to fill electronic prescriptions for controlled dangerous substances (“CDS”) (see, e.g., 21 C.F.R. § 1306.08).  Regulations of the New Jersey State Board of Medical Examiners (N.J.A.C. § 13:35-7.4A(g)-(h)) and Board of Pharmacy (N.J.A.C. § 13:39-7.11(h)-(i)) similarly permit electronic CDS prescriptions, subject to certain requirements.  But the State’s CDS regulations do not currently permit electronic CDS prescriptions (N.J.A.C. § 13:45H-7.8).

On August 20, 2012, Eric T. Kanefsky, the Acting Director of New Jersey’s Department of Consumer Affairs (“DCA”), proposed regulations to resolve this regulatory inconsistency.  DCA would add a new rule, N.J.A.C. § 13:45H-7.20, which would permit “[a]n individual practitioner [to] issue, and a pharmacist [to] accept for dispensing, an electronic prescription for a controlled dangerous substance, consistent with the requirements of this chapter and Federal law.”  This proposed rule would define “electronic prescription” as “a prescription that is transmitted by a computer device in a secure manner, including computer-to-computer and computer-to-facsimile transmissions.”  DCA also proposes to amend N.J.A.C. § 13:45H-7.8 to expressly permit an electronic prescription for Schedule II narcotics “[i]f permitted by Federal law, and in accordance with Federal requirements.”

These Federal requirements, set forth in 21 C.F.R. Parts 1300, 1304, 1306, and 1311, include provisions intended to balance the desire to permit the use of modern technology while “maintaining the closed system of controls on controlled substances dispensing” (75 Fed. Reg. 16236).  Thus, if DCA ultimately adopts these rules, New Jersey prescribers and pharmacists seeking to exercise their option to issue or fill electronic prescriptions will need to ensure that they comply with all Federal rules, including, as DCA’s proposed rule reminds, a requirement for a third-party audit by a DEA-approved certification organization to verify that the technology used satisfies DEA security standards (see 21 C.F.R. § 1311.300).

In addition to “eliminating any confusion that may exist with respect to filling electronic prescriptions for controlled dangerous substances,” DCA also believes that “[e]lectronic prescriptions are more efficient and less susceptible to errors.”  With proper controls and checks, electronic prescriptions can make it more difficult for patients to try to fill fraudulent prescriptions by, for example, forging doctor’s signatures on stolen prescription blanks or altering the dosage that the doctor prescribed. Electronic prescriptions also support other health care reform initiatives, including increasing the use of electronic medical records, which can facilitate improved care coordination.

The public may comment on DCA’s proposal until October 19, 2012.  But given the potential advantages of electronic prescriptions and the strong controls required by Federal law to prevent their abuse, I would expect the comment to be light and these regulations to be adopted.

New Jersey’s Medical Marijuana Program: (Almost) Off and Running

Three summers ago, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a position paper in support of New Jersey’s then-pending “New Jersey Compassionate Use Medical Marijuana Act.”  The Act passed the following January but the road to implementation has been rocky, as I blogged about here and here.  In April of this year, a prospective patient and physician sued the state’s Department of Health and Senior Services and Department officials alleging that the “selection of six nonprofit groups to grow and sell the drug at alternative treatment centers was ‘arbitrary and capricious,’ and that the regulations it created to govern the program were not consistent with the law’s intent and were ‘intentionally designed with the intent to interfere with the medical marijuana program.’”

There are, however, signs of progress.  Yesterday, the Wall Street Journal reported that: “[f]or the first time in generations, marijuana is legally growing in New Jersey.”  According to the Journal, the Greenleaf Compassion Center, the first and only nonprofit to secure a permit from the Department of Health to grow marijuana, has for about a month been growing its first plants in a secure 5,000-square-foot warehouse in an undisclosed location.  By September, Greenleaf expects to begin serving patients at a dispensary to be located in Montclair, which is in the northern part of the state.

Another nonprofit, the Compassionate Care Foundation, was denied permission to set up shop by the zoning board of one town earlier this year, but was subsequently given the go ahead by officials in another town, Egg Harbor Township, which is in the southern part of the state just inland from Atlantic City.   Compassionate Care’s Chief Executive Officer William J. Thomas told the Journal that “New Jersey’s Division of Gaming Enforcement, which typically vets casino owners for possible organized crime ties, is nearly finished with extensive background checks[.]“  Mr. Thomas “hopes to have a permit to grow pot by the end of August” and “to harvest a crop around November.”

The remaining four nonprofits which were selected by the Department of Health in March of 2011 have yet to find permanent homes. Breakwater Alternative Treatment Center, which was approved to operate in the central part of the state, was rejected last year by one town and is, according to Republican Assemblyman Declan O’Scanlon, a supporter of medical marijuana in New Jersey, “going ahead with talks with several municipalities.”  The Journal was not able to find out where the three other nonprofits are in the process.

Democratic Assemblyman Reed Gusciora, who sponsored New Jersey’s medical marijuana legislation, has called for hearings on the cause of the ongoing delay.  In April, Governor Christopher J. Christie explained that the state has taken its time because he does not want New Jersey to “become Colorado or California.”  Interestingly, recent research suggests that even in those very liberal states the legalization of medical marijuana was not accompanied by increases, and may have even been accompanied by decreases, in the use of marijuana or other substances such as alcohol and cocaine among high school students.  This should provide some comfort to Governor Christie and others concerned about the ancillary effects of legalization as New Jersey’s program moves closer to full implementation.

Another Multi-Billion-Dollar Settlement for Pharma

As reaction to the Supreme Court’s decision on the Affordable Care Act (“ACA”) continues to make headlines with mind-numbing political arguments surrounding the distinction (or lack thereof) between a “tax” and a “penalty,” healthcare fraud enforcement rolls on unchanged.  This week brought news of yet another pharmaceutical company entering into an eye-popping settlement following damning allegations that it fraudulently marketed their drugs and misled the FDA.

In another record-breaking settlement amount, GlaxoSmithKline agreed to pay the U.S. government $3 billion – a criminal fine of $1 billion and civil fine of $2 billion – for fraudulent promotion of Paxil, Wellbutrin, and six other drugs, and for failing to notify the FDA of safety information on Avandia, its blockbuster diabetes drug.

Particularly, GSK’s marketing staff is alleged to have illegally paid doctors in an effort to increase usage of its drugs.  This allegedly included speaking engagements, vacations (including hunting trips, spa vacations, and trips to Hawaii), and tickets to entertainment events – including a Madonna concert.  The government also alleged that GSK marketed Paxil for use in children, for which it was never approved, and marketed Wellbutrin for sexual dysfunction and weight loss, two conditions for which it was not approved.  Regarding Avandia, the Justice Department alleged that GSK did not notify the government of post-approval studies that indicated that taking the drug may result in heart disease and/or heart attacks.

However, as the New York Times reported, GSK made $10.4 billion on Avandia, $11.6 billion on Paxil, and $5.9 billion on Wellbutrin during the years covered by the settlement – totaling nearly $28 billion in profits on these three blockbuster drugs.  We’ve seen this before.

As Professor Katrice Bridges Copeland has impressively written in her article Enforcing Integrity in the Indiana Law Journal, and as this blog has noted in the past, corporate integrity agreements (“CIAs”) and large fines continue to hold questionable – if not very little – deterrent value.  As Copeland has argued, pharmaceutical companies continue to expect to be subject to fines and a new CIA following each new fraud offense.  As long as the company does not get excluded from any of the federal healthcare programs, none of its executives go to jail, and the monetary penalties make up only a fraction of the profits the pharmaceutical company makes on the drug, there are few incentives for companies to change their fraudulent practices.

Unfortunately, the ACA does relatively little to bring about change in healthcare fraud enforcement.  Sure, there are some statutory changes (e.g., now an Anti-Kickback statute violation explicitly constitutes a predicate offense for the False Claims Act), and it provides more funding for anti-fraud efforts, but the underlying structural problems that have failed to prevent or curtail healthcare fraud remain.  Put simply, the amount of offenders and settlement amounts continue to grow.  Indeed, the ACA may have altered the healthcare landscape, but the industry’s major enforcement challenges remain.

First Circuit Finds Generic Drugmaker Had State Law Duty to Stop Selling Unsafe Drug

Earlier this month, the First Circuit surprised observers when it held, in Bartlett v. Mutual Pharmaceutical, that a state law product liability suit founded on the claim that a generic drug was unreasonably dangerous due to a design defect was not preempted by the Federal Food, Drug, and Cosmetic Act (FDCA).  In coming to its decision, the First Circuit distinguished Pliva v. Mensing, in which the Supreme Court held that the FDCA does preempt a state law product liability suit founded on the claim that a generic drug was unreasonably dangerous due to a label that failed to warn of the drug’s dangers.

Pliva hinged on the fact that the FDCA and its implementing regulations “require that the warning labels of a brand-name drug and its generic copy must always be the same– thus, generic drug manufacturers have an ongoing federal duty of ‘sameness.’”  Because the defendant in Pliva could not fulfill its alleged state law duty to add stronger warnings to its label without violating the federal duty of sameness, the Supreme Court held that the state law product liability suits at issue could not go forward.  As the First Circuit put it in Bartlett, “Congress cannot have wanted the generic to pay damages under state law for a label that the FDA required.”

The defendant in Bartlett argued that, because generic manufacturers cannot alter the composition of a drug, “[Pliva's] policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning.”  The First Circuit rejected this argument, finding that

“…although Mutual cannot legally make [the drug at issue] in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context.”

James M. Beck, at the defense-oriented blog Drug and Device Law calls this result “startling[,]” pointing out that “before Bartlett the post-[Pliva] precedents had universally rejected arguments that supposed state-law duties (no state high court has ever recognized such a duty) to remove generic drugs from the market altogether could survive preemption.”  Beck argues that

“[a]nybody could always avoid liability by not selling any products at all — but that would make preemption ‘illusory,’ and also totally defeat the purpose of the Hatch-Waxman Amendments to encourage production of generic drugs. Sooner or later, one plaintiff or another will argue that every generic drug ever approved should be removed from the market.”

While plaintiffs may argue that generic drugs have design defects and should be removed, their arguments are unlikely to succeed.  As the First Circuit explains, many state courts refuse to review claims that FDA-approved prescription drugs are defectively designed.  Even where such claims are permitted, manufacturers can defend against them by showing that a drug “was unavoidably unsafe but was highly useful and had an adequate safety warning[.]“  For unknown reasons, the defendant in Bartlett “abandoned that defense on the eve of trial.”

That said, Bartlett highlights a number of important questions.  Should generic manufacturers, as the First Circuit decision suggests, have a duty to perform their own continuous risk-benefit analysis of the drugs that the FDA has approved them to sell?  They may be in the best position to do so, although monitoring is likely to be more complicated the more manufacturers of a single drug there are.  Should they have a duty to stop selling a drug as soon as the risk-benefit balance — in their sole estimation — tips?  Maybe, maybe not.  Drugs are, after all, “highly useful” and there are inevitably winners as well as losers when manufacturing is discontinued.  Such a decision might be better entrusted to the FDA.

Legislation is pending in Congress that would overturn Pliva by giving generic manufacturers the same authority that branded manufacturers have to add warnings to their labels.  Perhaps Congress should also clarify manufacturers’ obligations (or lack thereof) with regard to removing drugs from the market.

Risperdal: Low Hanging Fruit for States with Medicaid Deficits?

Think of it as a clarion call, a shot across the bow, or even the smell of carrion wafting towards the nostrils of bean counters and state administrators everywhere–but any way you look at it, be sure that the Risperdal verdict of $1.2 billion dollars against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., has states across America checking the terms of their own False Claims Act and counting how many prescriptions of the drug were filled through Medicaid.

It is no secret that states face shortfalls; it is no secret that Arkansas was awarded $1.2 billion, $5,000 per prescription plus a relatively minor amount for deceptive practices.  Think back to the tobacco litigation of the 90s for an apt analogy–states across the country plugged their deficits with tobacco money to the tune of billions. Make no mistake, the Risperdal verdict is a game changer–from the perspective of the litigation itself, the Risperdal litigation to come, and what that litigation signals– especially from  a Pharma and Healthcare legal compliance perspective going forward: because you can rest assure that after states have finished counting Risperdal prescriptions filled through Medicaid and prepped the requisite paperwork,  they will then commence their search for “the next Risperdal.”

In case you missed it, here’s a snippet from Zack Buck’s superb article on the verdict and the “rigid and severe” penalties associated with the False Claims Act.  Reading the rest of it is time well spent (link below).

News of the $1.2 billion verdict against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. for their roles in marketing Risperdal during the middle of last decade sent reverberations through the industry earlier this week.  The award resolved Arkansas’ claims that the companies fraudulently marketed the “second generation” antipsychotic, misleading doctors and deceiving the state’s Medicaid program into paying for 239,000 prescriptions of the drug.  Specifically, the state claimed the companies minimized Risperdal’s dangerous side effects by not disclosing the risks on its label, marketed the drug for unapproved uses, and characterized it as more effective than competitors’ drugs.

After the jury found that the companies had misled doctors about the risks associated with Risperdal, Judge Tim Fox awarded $11 million for the violation of the state deceptive trade practices act. Further, Judge Fox turned to the Arkansas’ False Claims Act (FCA) – which carries a minimum $5,000 civil penalty for each violation of the Act (the federal FCA requires a minimum civil penalty of $5,500) – and applied Arkansas’ statutory penalty to the 239,000 prescriptions of Risperdal paid for by Arkansas Medicaid between 2002 and 2006, totaling $1.195 billion in damages.  According to Janssen, the state paid only $8.1 million for Risperdal during the 3½ year time period, which amounts to less than 1% of the damages amount.  The companies plan to appeal.

http://www.healthreformwatch.com/2012/04/15/rigid-severe-penalties-of-fcas-on-full-display/

New Jersey’s Recent Efforts to Combat Prescription Drug Abuse

New Jersey is adding to its arsenal of resources to investigate and combat prescription drug abuse and diversion.

On January 18, 2012, New Jersey’s new Attorney General, Jeffrey S. Chiesa, announced the launch of the State’s long-awaited Prescription Monitoring Program (“PMP”), which permits the State to monitor prescriptions for controlled substances.  (I blogged last June about the passage of the statute authorizing the PMP, N.J.S.A. 45:1-45-1-52.)  According to AG Chiesa, the PMP is “a powerful new tool in the State’s fight against the abuse and diversion of prescription drugs, and the often-heavy reimbursement costs of fraudulently-obtained prescription medication borne by health insurance companies, the State, and ultimately taxpayers.”

Before the PMP, investigators of inappropriate prescribing or usage patterns, absent timely and reliable complaints, had to pick which pharmacies, providers, or patients to investigate and then cobble together data from these various sources, looking for the proverbial needle in a haystack.   It often took quite a bit of time and resources, not to mention a bit of luck, to find the evidence required to demonstrate diversion or abuse.

The PMP now centralizes these data in a searchable database maintained by the State’s Division of Consumer Affairs.   Since September 1, 2011, the PMP has been collecting information from 2,000 pharmacies throughout the State every 15 days regarding the prescription sale of all drugs classified as controlled dangerous substances (CDS) and human growth hormone (HGH).   As AG Chiesa explains, the PMP “database will help the Division of Consumer Affairs and other law enforcement agencies identify and investigate individuals and businesses suspected of fraudulently diverting controlled drugs for abuse. By highlighting the location, nature, and extent of abuse throughout the state, the information collected will also better inform our healthcare initiatives and addiction-treatment efforts.”

Investigators are not the only folks with access to this data.  Beginning January 4, 2012, State-licensed prescribers and pharmacists may register to be able to access the PMP database to help inform their professional decision making with regard to current patients.  Consumer affairs also will provide information garnered from the database to other law enforcement agencies and the professional licensing boards, as permitted by law.

By May 2012, the State intends to enhance and expand the PMP database to permit more sophisticated statistical analysis.  According to the State:

When fully expanded, the NJPMP will generate reports on geographical areas with unusual CDS or HGH prescription activity during a specific time frame; identify practitioners in each county who prescribed the largest quantities of a specific drug during a given time period; and provide other information that can help identify and compare troubling patterns of CDS and HGH activity.

By using the PMP, investigators may more swiftly identify patients who are filling multiple prescriptions for CDS or providers who are authorizing large quantities of CDS.  With this information, investigators may examine whether there are medically appropriate justifications for these prescriptions, or if this is evidence of diversion, abuse, or fraud.   For example, the State’s press release recounts that investigators used the PMP to identify a patient who obtained a four-month supply of methadone and oxycodone in just over one month by presenting what are now believed to be fourteen forged prescriptions to three different pharmacies, and they made this discovery within a month of the abusive behavior.

To help the State maximize the potential of the PMP, AG Chiesa announced the “next step” in the State’s “comprehensive, statewide plan to fight the diversion and abuse of prescription drugs” — a reorganization and expansion of the Enforcement Bureau (“EB”) of the Division of Consumer Affairs.  The EB is the investigative arm of the various state professional boards, including the State Board of Medical Examiners and Board of Pharmacy, which investigates potential professional misconduct by the licensees of these Boards.   The AG plans to add investigators to the three investigative sections that play “a key role in the Division’s effort to curb prescription drug diversion and abuse” to permit the EB to develop expertise in identifying “the unlawful distribution and diversion of prescription medications.”

First, the AG plans to grow from 7 to 9 the number of undercover investigators in its drug diversion section, which investigates “cases related to the distribution and diversion of prescription drugs; indiscriminate prescribing and dispensing; prescription fraud; and enforcing the bans enacted by the Division of Consumer Affairs on so-called “bath salts” and other designer drugs.”  Indeed, the State’s press release reports that one investigator has already been hired.

The AG also plans to add 4 pharmacist/investigators to the current 9 in the pharmacy inspection section, to inspect pharmacies and review security protocols to try to prevent theft of CDS.

It then will add three nurse/investigators to its quality of healthcare section, which currently has 7 registered nurses or other experienced investigators.  By monitoring the quality of care provided by licensees primarily of the medical and nursing boards, this section often oversees investigations concerning “drug impairment and self-use by practitioners, and health insurance fraud.”

The AG also said that the 20 investigators in EB’s other 2 investigative sections will be available as needed to support the State’s efforts to fight prescription drug diversion.

There is much to applaud here.  Public health demands increased efforts to curb prescription drug abuse and diversion.  If used appropriately, these initiatives offer considerable promise — individuals, including practicing health care professionals, in need of substance abuse treatment can be identified in a more timely fashion; practitioners lacking adequate training in the prescribing of controlled substances can be required to take additional courses; and dishonest or dangerous practitioners can lose the privilege of licensure.

These initiatives also raise a number of policy and legal questions that need to be fleshed out.  These include, just to identify a few:

• How do we ensure patient privacy? Prescribing doctors and pharmacists must certify that they are accessing the database for a current patient, but how do we verify the truth of their certifications?
• When will information be shared with other law enforcement entities?
• New Jersey’s statute permits the State to enter interoperability agreements with other states so that each state may access the other’s data. When will other states be able to access New Jersey’s database?
• The statute does not require prescribing doctors and pharmacists to access the database — should it, to better inform care decisions? (The Massachusetts Senate unanimously passed S. 2122recently, generally requiring doctors to check the State’s PMP database before prescribing a Schedule II or III narcotic drug to a patient for the first time. Not everyone, however, thinks it’s a wise proposal.)
• Should New Jersey amend the PMP statute to permit non-prescribing substance abuse treatment providers, such as social workers or psychologists, to access the database?
• How do we discern from the data which high volume prescribers may be too readily prescribing — or even complicit in diversion — and which are needed palliative care doctors who treat a disproportionate number of patients in chronic pain? It is critical that well-trained, ethical pain management doctors are not deterred from practicing their specialty by fear of being caught up in a protracted, potentially career-ending investigation. (Somewhat relatedly, the Florida Legislature recently killed a bill that would have prohibited doctors from writing prescriptions for controlled substances while arrested and awaiting trial on — but not yet convicted of — a charge relating to controlled substances.)
• What public policy initiatives can be adopted to ensure that all patients with legitimate prescriptions for pain medication can get those prescriptions filled at local pharmacies?

I am encouraged by New Jersey’s continued efforts to combat the real and deadly challenges of prescription drug abuse and diversion, but I encourage balance in the implementation of these new tools so that patients suffering from pain are not denied appropriate palliative care.  I am eager to work through these issues.  Let’s start a dialogue.  I welcome your ideas.

New Evidence on Smoking Marijuana and Lung Function; Update on New Jersey’s Nascent Medical Marijuana Program

This week’s JAMA includes an article reporting on new evidence that smoking marijuana does not negatively affect lung function. Smoking tobacco has long been known to harm the lungs and to increase the risk of developing chronic obstructive pulmonary disease and lung cancer, both leading causes of death. The risks posed by smoking marijuana, on the other hand, have largely been assumed, based on the fact that “[m]arijuana smoke contains many of the same constituents as tobacco smoke[.]”

The authors of the JAMA article analyzed data from a 20-year longitudinal study of 5,115 people in 4 American cities who “comprise a broad cross-section of typical tobacco and marijuana use patterns” and found that “[w]ith up to 7 joint-years of lifetime exposure (e.g., 1 joint [a day] for 7 years or 1 joint [a week] for 49 years)” there was no evidence of an adverse effect on the lungs. Very heavy marijuana use in excess of 7 joint-years of lifetime exposure could prove harmful, but there were not enough heavy users in the study to demonstrate this.

High-quality epidemiological evidence like this latest JAMA study will be key to filling in the gaps in our knowledge about marijuana’s safety profile. While double-blinded randomized controlled trials are considered the gold standard for evaluating the safety and efficacy of drugs, they are not always an option, particularly where the goal is to gather data over many years. Marijuana’s classification as a Schedule 1 controlled substance adds to the difficulty of mounting clinical trials. Given this, it is (or will be) a very good thing that New Jersey’s still-nascent medical marijuana program will include a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about the drug’s safety and efficacy.

The statute authorizing New Jersey’s medical marijuana program was passed two full years ago, in January 2010, but the road to implantation has been a long and rocky one. (My previous posts on the subject are here, here, here, and here.) While the Christie Administration is now on board, local towns have proved resistant to efforts to site alternative treatment centers that would grow and/or dispense marijuana there. In the Associated Press earlier this week, Geoff Mulvihill writes that “[s]o far, only one [of the six groups authorized by the state to operate alternative treatment centers] has announced that it has secured local approvals. … Three others have been shut out of their chosen locations by local government bodies, despite assurances that security at the dispensaries would be tight and that pot would be given only to patients who are truly sick.”

The state may be fighting back. Nina Rizzo reports in the Asbury Park Press that Assemblyman Declan O’Scanlon has announced “that he will introduce legislation next week that would prohibit counties and municipalities from interfering with the development of medical marijuana cultivation and distribution centers by extending their protections under the Right to Farm Act.”

Such a heavy-handed approach may be necessary in the short term, to ensure that all six authorized alternative treatment centers can get off the ground. If the New Jersey Compassionate Use Medical Marijuana Act and its regulations work as they are intended to, however, public confidence in the program should grow.

Recommended Reading: Recent Scholarship with Implications for Pharmaceutical Pricing and Access

Bundles in the Pharmaceutical Industry: A Case Study of Pediatric Vaccines, by Kevin W. Caves and Hal J. Singer of Navigant Economics, provides a technical but still accessible analysis of the anticompetitive effects of vaccine manufacturers’ practice of conditioning price discounts on physician buying groups agreeing to purchase the manufacturers’ vaccines in a bundle and agreeing not to purchase other manufacturers’ products.  The article begins with an interesting overview of the characteristics of the vaccine market, an introduction to the physician buying groups that purchase vaccines and to the anti-kickback concerns they raise, and a summary of the (somewhat up in the air) legal standard for when bundled discounting becomes an antitrust violation.

The authors then present their analysis of the uphill battle Novartis (a source of funding for the article) will have to fight to induce physicians to “break the bundle” and buy its new meningitis vaccine.  The authors conclude that even if Novartis were to give away its meningitis vaccine for free, “buyers defecting from [Sanofi Pasteur's bundle of vaccines, which includes Sanofi's meningitis vaccine,] would still lose $14.05 per patient in expected value.”  They present data indicating “that buyers unencumbered by … Sanofi’s loyalty contracts are over three times as likely to purchase [Novartis' vaccine], relative to encumbered buyers…” and conclude that enough of the market is foreclosed to Novartis to establish a presumption of anticompetitive effects and concomitant harm to consumers.  Per the authors, “[i]n an industry served almost exclusively by large, multi-product incumbents, with no prospects for generic competition and extremely limited entry by competitive rivals of any kind, these findings have significant implications for public policy and antitrust enforcement.”

Somewhat less accessible (due to a plethora of equations) but still well worth reading is Tort Liability and the Market for Prescription Drugs by Eric Helland, Darius Lakdawalla, Anup Malani, and Seth Seabury.  Helland and his co-authors present the results of an empirical study of the relationship between product liability rules and drug price and utilization.  While the effect of a liability rule can often be studied by comparing a state that makes a change to the rule with one that does not, the authors had to modify this approach because drugs are sold nationally.  They determined the exposure to punitive damages caps of each of nearly 16,000 drugs by first determining each drug’s geographic distribution of sales, a figure which varies from drug to drug due to geographic variation in the prevalence of disease.  The authors found that the degree of exposure to caps was correlated with an increase in drug prices but also with an increase in drug utilization.  Tighter liability standards also correlate with a reduction in adverse drug reactions.  The authors write that their numbers “imply that if every remaining state adopted some reform, there would be a 23% increase in all [adverse] events and a 25% increase in serious [adverse] events … among branded drugs.”  They conclude that “on balance, liability improves consumer and social welfare.”

FDA’s ‘Bad Ad’ Program is in Full Effect

Last spring, the Food and Drug Administration (FDA) launched the Truthful Prescription Drug Advertising and Promotion Program (known more accessibly as the “Bad Ad Program“). The goal of the program is to enlist the help of health care professionals, consumers, and industry representatives in noting FDA violations and reporting activities and messages that are false or misleading. Common drug marketing violations include omitting or downplaying risk, overstating effectiveness, promoting off-label uses and making misleading drug comparisons. The program is run by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), which is responsible for “ensuring truthful advertising and promotion of prescription drugs.”

The FDA published a year-end report in May noting that the program has been successful in raising awareness. DDMAC received 328 reports of potentially untruthful or misleading promotions in one year, with the majority of those submitted by health care professionals (188 reports) and consumers (116 reports). The report notes that prior to the Bad Ad program, the FDA received an average of about 104 reports per year.

And the Bad Ad tips are still coming in. Just at the end of last month, DDMAC issued a reprimand letter to Pfizer’s Vice President of US Regulatory Affairs regarding misleading advertising of drugs on the company’s Lipitor website. A complaint to the Bad Ad program observed that the links from the Lipitor site led to pages for the drugs Caduet (for high cholesterol and blood pressure), Norvasc (for high blood pressure), and Chantix (for smoking cessation). But each of those pages failed to note any of the risk information associated with the drugs, which is a violation of the Federal Food, Drug, and Cosmetic Act.

The FDA states that “by omitting the most serious and frequently occurring risks associated with Caduet, Chantix, and Norvasc, the webpage misleadingly suggests that these drugs are safer than have been demonstrated.” The letter ends with a request that Pfizer immediately stop the dissemination of violative promotional materials for the drugs. The company was to have submitted a written response to the complaint by September 14^th that states how they will comply with the request.

While the Bad Ad program may be working to raise awareness among health professionals and consumers, one violation may not be enough to induce compliance from pharmaceutical companies. In fact, DDMAC already chided Pfizer in March of 2009 for omitting risk information for Caduet and Chantix. In that case, Pfizer sponsored links for the drugs on Internet search engines. The sites linked to did not mention any risk information and therefore, presumably,  can be said to have also represented the products in a manner which, as above, suggests that these drugs are safer than have been demonstrated.” The most recent letter states that “DDMAC is concerned that Pfizer is continuing to promote its products in a similarly violative manner.” A citizen’s task force is a good way for the FDA to multiply their eyes and ears to keep tabs on misleading and/or violative advertisement. We’ll see what further successes the next year-end report for the Bad Ad program can show. Or, perhaps, success might also be measured in the absence of violations.

Generic Drugs, Cost-Effectiveness, and Confidence

Smarter prescribing and better medication management are linchpins of current efforts to care for those with chronic medical conditions in a more consistent, coordinated, and, it is hoped, affordable manner.  A study reported in last month’s Health Affairs found that using medication to control patients’ blood sugar levels and lower their blood pressure and cholesterol is not just cost-effective, it can actually save money by reducing “downstream complications and the use of health services that outweigh the cost of the medications themselves.”  Notably, these cost savings can only be achieved if the medications in question are generics.  The authors conclude that “in a health care system strapped for resources, physicians will increasingly use generics, and patients will have to expect that most of their medications will be generic.”

As the authors also note, resistance to generics, on the part of both patients and their doctors, is longstanding and persistent.  Some of this can be chalked up to the intense and wide-ranging marketing campaigns that innovator companies mount on behalf of branded drugs.  Branded medications used to treat chronic conditions are especially heavily marketed, including through the use of free samples.  Numerous studies (here’s a recent one out of Vermont) show that physicians with sample closets in their offices are less likely than those without sample closets to prescribe generics where appropriate.

Interestingly, the Centers for Medicare and Medicaid Services announced earlier this year that Medicaid Part D prescription drug plans “may incur expenses related to distribution of and reporting on generic drug samples, provided to members within a physician’s office setting, under the plan’s administrative cost structure if doing so is consistent with a cost effective drug utilization management program.”  CMS explained that generic samples have the potential to reduce the government’s overall costs and to promote compliance with drug therapies by reducing enrollees’ current and future cost sharing expenses.  (George Van Antwerp argues here that CMS overstates the benefits of generic samples, but only because generic fill rates are rising so fast without them.)

Marketing is not the whole story behind lingering resistance to generics, though.  As the New York Times recently reported, most generic drugs are manufactured in “a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.”  While plants in the United States are inspected at least once every two years, the Food and Drug Administration has historically lacked the resources to provide the same level of oversight to foreign facilities.  An “epoch-making” agreement between the FDA and generic drug manufacturers will, assuming it is approved by Congress, change this.  The manufacturers have agreed to pay $299 million in annual fees to, among other things, fund inspections of foreign plants on the same schedule that applies to domestic plants.  As the Times notes: “[T]he generic drug industry is no longer a motley collection of struggling mom-and-pop companies.  Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.”

Of Pain and Suffering, Morphine and Global Shortages

In recovery for more than 18 years, up until yesterday I had little good to say about narcotics. Having seen over the years at close quarters what drug and alcohol abuse can do to people and families, I could be considered almost virulently anti-drug. I have no patience for abuse– which may well have spilled over into use. The constant barrage of Pharma commercials which promise that I can avoid any of the discomfort associated with daily life has only added to my distaste. I receive dozens of spam messages through this blog each day promising me cheap oxycontin and the like through internet clearing houses. We are a Pharma Nation. But yesterday, as is so often the case, born of personal experience, I came to appreciate the pain relief that properly administered drugs can bring– and to also appreciate the gravity of the lack of such medicines across the globe.

I woke up and broke out in a cold sweat and quickly began writhing around and wailing in pain like a wild animal caught in a bear trap. The pain came in excruciating waves radiating as though I had just been punched below the belt– repeatedly. Afraid it may have been appendicitis or something equally as dire, I had my son call 911. The police showed up immediately, but the all volunteer ambulance squad took close to 40 minutes to get here. I cursed, hollered, moaned, pled– and even shrieked, the whole time. I did the same even after we reached the Emergency Room, though there I peppered my plaints with apologies.

Convinced it was a kidney stone, the nurse and doctor insisted I take something for the pain. Explaining my recovery status I  protested, but ultimately relented asking if they could make the drug/dose “as little as possible.” They gave me morphine and Toradol. Moments later I became human again. It stopped the pain, it didn’t get me “high.”

The CT scan showed the stone to be making its may down to my urinary tract– all 4 painful millimeters of it. It would need to be 5 millimeters, however, for it to be surgically removed. As such, I longingly wait for it to pass.

Over the years, because I’ve seen so many alcoholics and addicts relapse after using prescription drugs, despite severe pain I’ve eschewed the use of prescription pain relief– always risky to wake a sleeping dragon. But this was something else entirely.

So what does this all have to do with health reform and law? Outside the U.S. there are severe shortages of morphine. Although a dose costs only pennies, the “War on Drugs” is said to have rendered the drug largely unavailable for medical use. In India, morphine is said to be “almost impossible” to get. In the video below,  Diedrick Lohman of Human Rights Watch asserts that “freedom from medical pain should be a basic human right.” I’m not sure how that would be defined legally, but conceptually, I agree. If you ever find yourself within the grips of an unrelenting pain– a pain so great you no longer even feel human–you may too. The video below details the problem, in excruciating terms.

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