Will Physician Gifting Practices Guidelines Work?

Pens and prescription pads flashing branded pharmaceutical drug names and logos could become less visible in doctor's offices as a result of PhRMA's “Code on Interactions with Healthcare Professionals.” But will it make the practice of medicine any better?

Briefly the new code of interactions instructs pharmaceutical companies not to distribute clothes, office supplies, and other gifts bearing company logos or product brand names to physicians and clinics. In addition, it also asks these companies to refrain from paying for physicians' meals, even during medical education events.

Many feel that these may only have a superficial effect. Why because compliance with the guidelines is purely voluntary. In fact, the guidelines are not even supposed to be a confession that gifts to doctors from the pharma industry influence a doctor's prescription writing skills. So when there's no problem to begin with, what problem will the guidelines solve. Perhaps they will solve just the problem of a perception that free gifts influence prescriptions.

Many from the pharmaceutical industry and doctors, though have shown respect to the guidelines, they scoff at the notion that pens and mugs are meant to influence a medic's practice.

Why Freebies may not be a bane?

Consider free samples of drugs, many physicians look up to these freebies for treating poor and and underinsured patients. Further, the samples also enable both doctors and patients to assess their tolerance of a novel drug before they purchase it. Thus, saving them from undue expenditure.

Often medical models and charts gifted to doctors help them to educate patients better, does it then really matter whether they carry a logo and a brand name? Free pens, flash drives, staplers, calculators paperweights, etc, may simply serve to support doctor's practice. But that a “viagra pen” will influence a prescription for “strep throat” is pretty hard to believe.

Further, some even contend that the guidelines don't at all help to put a stop to give aways other than freebies meant to influence physicians. And some even see it as a clever realization by the industry that rather than spending on freebies, the money could be spent in ways to ensure a better return on investment for them.

Whether or not the freebies influence a doctor's prescription drug advice may not be crystal clear, but what is, is that each practicing doctor has a conscience of her own, and as long as that is intact, no amount of supposed influence should be a cause for worry.

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XVII International AIDS Conference: 4 Precious Initiatives

The XVII International AIDS Conference (IAC) held at the Mexico City, from Aug. 3 through Aug. 8 days was an exquisite forum for sharing and showcasing of ideas from international experts. It also saw the launch of various invaluable initiatives by different organizations. Of which, the following four seemed to be quite striking.

1. The Release of “Blueprint 2008,” for AIDS Vaccine Development by The International AIDS Vaccine Initiative (IAVI)

Despite the fact that this year's IAC conference was devoid of a plenary session on AIDS vaccine, like the previous ones, many researchers intensely reemphasized the need for a vaccine to make the world AIDS-free.

The IAVI announced the release of “Blueprint 2008.” I think AIDS vaccines are positively the ultimate answer, but till that time HIV drugs should be made available to all those who need them.

The Blueprint 2008 stresses on three key areas:

The mission to develop a vaccine should be divided up into a set of intermediate milestones, as this would enable measurement of progress as well as hold people accountable.

There's a need to trim and improve the pipeline by a big measure. The number of 30-or so candidates in the pipeline need to be reduced based on the “probability of success.”

The final recommendation calls for a sustained effort with an ample supply of new cader of young researchers coupled with stable financing for flexibility.

2. The YWCA Report: ‘Nothing About Us Without Us: a report from the HIV-Positive Women’s Forum’

This insightful YWCA report comes in the wake of the unique challenges that women living with HIV face, and the special needs that they have. It is an analysis and evaluation of the “Positive Women’s Forum,” coupled with the feedback gathered back then. The Positive Women’s Forum was an unprecedented meeting conducted on July 2007 as a segment of the International Women’s Summit on HIV and AIDS.

The report offers insight, and stresses that for epidemic control programs to be effective women living with HIV must come forward and lead the AIDS response. Also that HIV positive women must become involved equal partners to shape AIDS programs and policies.

3. The Plan: “Global Alliance on HIV”

The program is the brain child of the International Federation of Red Cross and Red Crescent Societies (IFRC) and was launched in the Americas just before the conference.

The initiative, expected to benefit over 7 million would be prevalent in Latin America and the Caribbean. The objective is to raise about 22.3 million Swiss francs, which translate into US$ 21.4 million, in order to give an impetus to HIV and AIDS programs in the Americas. It is slated to begin with the following ten nations, Argentina, Belize, Colombia, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras and Jamaica. However, in a couple of years a larger number of countries would be included.

Of the 33.6 million people infected with HIV around the world, 1.6 million live in Latin America. And this program seeks to adapt an approach that's based on the prevention, treatment, care and reduction of stigma and discrimination. Furthermore, of the 7,300,000 people estimated to benefit, groups of special focus would include children with HIV, children orphaned due to HIV, sex workers and of course all those living with HIV.

4. The Open Society Institute Report: "Our Lives Matter: Sex Workers Unite for Health and Rights"

The report “Our Lives Matter:..”published in August by the Open Society Institute provides coverage of how sex workers in eight countries have organized themselves to protect their health and human rights. It delves deep into the many ways by which sex workers have battled, violence, extortion and incarceration in their fight against securing equal health opportunities. The eight groups from different countries profiled in the report include Sex Worker Education and Advocacy Taskforce (South Africa), Davida (Brazil), Durjoy Nari Shongho (Bangladesh), Humanitarian Action (Russia), Durbar Mahila Samanwaya Committee (India), Odyseus (Slovakia), Urban Justice Center's Sex Workers Project (United States) and Stella (Canada).

While HIV is indeed a tough challenge for the world, but it's heartening that so much effort is being put in by every one from international organizations to the medical industry, to find a solution. And I'm sure the humans would win over the virus one day.

Off-Label Prescriptions – Is FDA's Regulation Sluggish?

Off-label use of medicines, though acceptable, is at times still controversial in the medical world. Sometimes the off-label usage is really warranted, at others times it is rarely warranted. But how efficient is the US food and pharmaceutical drug regulator, “the FDA,” in forestalling inappropriate promotion of off-label drug use?

The well-known phenomenon called “Off-label use,” refers to the practice of writing prescriptions for drug usage that's beyond the approved scope of a pharmaceutical drug. Some examples of such usage include SSRI medication (approved for depression) prescribed off-label to treat men suffering from premature ejaculation, Carbamazepine (an anti-convulsant), used to help individuals with bipolar disorder, and Methotrexate or (MTX), which has an approved use in treating choriocarcinoma, if often prescribed to manage an un-ruptured ectopic pregnancy.

In the United States the approval process requires that the Food and Drug Administration (FDA) be convinced of a drug's safety and effectiveness in treating a disease. Once there's enough convincing evidence, the manufacturer and the FDA formulate relevant language for the drug's label.

The following figure presents the frequency of violations.

However, recently a report compiled by the Government Accountability Office (GAO) brought out the fact that the FDA takes about 7 months to send warnings to pharmaceutical companies promoting potentially harmful for off-label uses of medicines. And it takes yet another 4 months for these companies to take corrective action on the violations.

The prevalence of off-label prescriptions can be assessed by the fact that more than 20 percent of prescriptions for 100 most commonly used drugs were found to be for off label use. Further, 60 percent of randomly selected drug prescriptions were again found to be for off-label use.

So, is the FDA sluggish in regulating undesirable off label use promotion?

Experts believe that it might be to quite an extent, due to the following reasons:

1. It takes about 7 – 11 months on an average to address violations.

2. The FDA doesn't specifically monitor off-label promotion. Rather, it's just a part of a larger number of oversight activities for combating all promotional violations. Further, not all submissions to the agency are scrutinized, hence there's a greater chance for violations bypassing the filter.

3. Its capacity to monitor is not at par with the high volume of materials submitted to it (it received 68,000 final submissions in 2007 itself). For instance, the FDA is only able manage a fraction of the thousands of continuing medical education (CME) activities each year, some of which include complaints from doctors to identify off-label promotions in the form of unsolicited statements from sales persons.

The chart below depicts the increasing caseload of the FDA

4. It doesn't keep a tab on all submissions, or the status of reviews supporting off label use, which gets in the way off regulating potential violations.

5. There isn't a standardized tracking system to manage the reviews.

6. Some violations by their very nature are difficult to track, such as the violative conversations between physicians and pharmaceutical drug sales representatives.

The following picture shows the percentage share of each of the target audiences.

While on one hand the FDA's Sentinel Initiative is a great program, the recently highlighted inadequacies of the system regulating off-label promotion of drugs doesn't seem to be encouraging. On the whole it seems that FDA might need to consider a much needed review of the system aimed at addressing unauthorized off label drug promotion, whether it is for conventional drugs or alternative medicines.

FDA's Sentinel Initiative, A Pathway To Drug Safety

In the wake of growing instances where several well known pharmaceutical drugs have turned out to be hazardous, the federal health officials have announced the launch of the Sentinel Initiative, a long term program to increase drug safety by data mining an analysis.

Drug recalls are a costly affair for patients, governments and pharmaceutical drug manufacturers alike. The case of “Vioxx” a pain relief drug, is one such glaring example that had reportedly got the manufacturer a revenue of $2.5 billion before it was voluntarily recalled by the company. Now, the company is faced with compensating the plaintiffs with millions.

The Present System Of Drug Safety

Compared to the proposed system the present system's efficacy is limited. The present system revolves around three basic sources of information.

1. A report filed by health professionals or patients who experience serious problems and pin down their suspicion the drugs and medical devices they prescribe, dispense, or use.
2. Case reports published in the medical literature.
3. Results of post-approval and other clinical studies when they are performed.

Further, recently advances in information technology have opened up newer avenues for monitoring the performance of medical products. Consequently, the FDA has expanded the risk management processes by expanding data source identification and data query capabilities, improving risk identification, assessment and mitigation strategies.

Still the challenges are:

1. That well-conducted, randomized, controlled clinical trials cannot uncover every safety problem.
2. In a majority of cases the clinical trials aren't diverse enough, large enough and long enough in duration to extract all the information on a product's safety.
3. Clinical trials aren't able to to reliably detect rare, serious adverse reactions that occur with long latency or in subpopulations who weren't a part of the studies.
4. Another challenge is the rate at which new new medical products surface in the markets. As new products emerge the likelihood for their interactions with other foods, biologics, drugs (vaccine, surgical drug,etc) and medical instruments and devices also increases.

The Sentinel Initiative

The prime objective of the Sentinel Initiative is to create a nationwide, integrated, electronic system (or the Sentinel System) for monitoring medical product safety.

Such a system when developed and implemented in stages would enable the FDA to access the capabilities of multiple, existing data systems (e.g., medical claims databases, electronic health record systems) to further improve the Agency's current capability.

Moreover, this system entails the establishment of a public-private partnership, comprising myriad organizations (e.g., FDA, data owners, subject matter experts, other government agencies, etc.

This organization would, for instance develop short- and long-term project goals. It would comprise a system architecture, which would enable focused queries of a variety of data sources, located at remote sites.

The data sources are to be maintained by their owners, who would also provide consent before queries are performed on the system.

Access to and analysis of large amounts of data forms the key feature of this program. Such a facility would improve upon the already existing architecture and processes for Risk Identification, Risk Assessment and Risk Minimization.

Risk Identification: The present adverse event reporting program gets information about many medical products, alternative medicines etc, and from a variety of voluntary reporters (e.g., prescribers, dispensers, and patients). However, its limitations entail underreporting of suspected adverse events, incomplete information to enable assessment of causality, the Agency not being able to know the percentage of people that were affected.


Risk Assessment: These processes suffer, as most of the information is received voluntarily, and doesn't help in the evaluation of the rate, or the impact, of known adverse events, or even the comparative assessment of outcomes using various products.


Risk Minimization: This part entails minimizing the possible harm, at the same time continuing to facilitate the safe use of a product for those patients for whom it will be beneficial.

Some tools for risk minimization are:

• Targeted education and outreach tools (meant to to increase knowledge and behaviors of healthcare practitioners and consumers)
  
• Reminder systems (prompt, remind, double-check, practitioners and/or patients in prescribing, dispensing, receiving the products)
• Performance-linked access tools (systems that link product access to laboratory testing results or other documentation)

Challenges

The real challenge lies in the implementation of the project and specifically the challenges pertain to Privacy Protection and Data Security, Scientific Credibility of the analysis, Maintenance of integrity by insulation from undue influence, Systems Approach for effective, life-cycle, safety surveillance of medical products, Governance to provide for incorporation of a broad range of expertise and minimize conflict, Inclusiveness of stakeholders' inputs in the standards and processes of the system, Transparency of study results to public and Open Source availability of software code, standards and methods.

The project is in its initial stage and would be unfolded overtime in phases, to begin with the Medicare database would be utilized for analysis. If the program moves along as has been conceived and the obstacles are overcome, then it surely would prove to be a “quantum leap,” in F.D.A's capacity to monitor drug safety.