Life Science Compliance Update

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33 posts from December 2009

December 31, 2009

Antidote Interview: Bio-Medical Education Companies and the Media

Recently William Heisel, Senior Communications Officer at the Institute for Health Metrics and Evaluation, interviewed me about the CME industry and the roll of medical education companies.  The questions he asked along with my answers were published on his blog under the title: Antidote: New Ways to Investigate Untold Health Stories. There are two parts to the interview.

Part 1: Medical education companies don't deserve media abuse
A key issue that we discussed was how bio-medical education companies insure that their passion is truly put to educational use and not channeled into a much bigger marketing effort. I noted that education companies are not influenced by the ‘big marketing’ efforts because we go out and apply for grants from a variety of sources including government, foundations, and industry.  

On another key point, I acknowledged that one of the reasons pharmaceutical and device companies pay for the education portion of CME classes is because it's part of their public health mission. In fact, by offering grants for courses, these companies are trying to make sure that doctors are as up to date as possible.  It's the translation of science to medicine. It's taking what's available in science and translating it into the clinical practice.


Regarding bias, I also outlined to Mr. Heisel that that medical education companies resolve bias as a part of their business practices to remain accredited. Most companies have all their information reviewed by an outside independent physician with no ties to industry to look to see if there is any bias.


Medical education companies also use a very strong vetting with their faculty to make sure that if they have a conflict, there is someone else reviewing their content. Some companies even send potential faculty a disclosure form before they are even engaged. Another way medical education companies eliminate bias is by disclosing information before presentations and disclosing information in the handout materials for the live meetings and on the Web.


Part 2:


During the second part of the interview, we took on the issue of how ghostwriting and conflicts of interest are two separate and unrelated issues. Whereas ghostwriting is publishing a paper and using the company to write it, CME does not do that. Rather the doctors who work for medical education companies have no direct contact with those that fund the programs, and most of the time they do not even know what company is funding the work. The doctors who teach CME courses are there to present good science.


The discussion then focused again on media coverage regarding industry-funded CME. I noted that most coverage has not been fair because journalists do not realize that there is no scheming behind the scenes with drug companies. Instead, CME is very straightforward. Companies choose to educate doctors about a particular topic, and then they apply to grants from foundations, the government and companies to pay for it. While certain companies have been put in the hot seat recently, these cases should not overshadow the convergence of science and industry that has benefited millions of patients and their physicians. I also acknowledged that certified CME companies do not have back and forth drafts with drug companies before a program is held.  That is the business of promotional education which is FDA regulated and not accredited.


At the end of the interview I noted that although health care reform is bringing about an uncertain time, doctors are always going to need education, and so there always will be a role for medical education companies. As a result, talking about the issues facing CME and bringing to light the changes that need to be made regarding the perception of bias and industry funding are important first steps to ensure the future of medical education.

December 29, 2009

FDA Guidance and the Courts: Whatever Happened to Rule Making?

While the health care debate is distracting most Americans about who is going to get insurance and what conditions are going to be covered, one extremely important health agency—the Food and Drug Administration (FDA)—is receiving a little less attention. Why should this concern you?


According to a recent article in The Regulation Policy Market Access Report (RPM), the public should be concerned because the FDA is invoking legal doctrines that “if accepted by courts will shield FDA legal determinations from scrutiny for at least substantial periods of time,” according to attorney Arnold Friede.


His article describes how FDA guidance, both draft and final, “has replaced rulemaking as the primary mode for the agency to communicate its official position on many matters.” As a result, he asserts that any guidance from the agency becomes “the functional equivalent of a rule or regulation.” To highlight such changes, Mr. Friede discusses the Teva Case.


The Teva Case


Teva Pharmaceuticals USA Inc. v. Sebelius, involved a case of eligibility for a first applicant for a 180-day generic drug exclusivity. In deciding the case, “Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia squarely addressed and rejected many procedural obstacles, analogous to those advanced by FDA in the BBK case, interposed by the agency in an effort to avoid judicial review.”


In explaining this decision, Mr. Friede noted that since the FDA had not provided a “definitive answer” on the agency’s view regarding this issue, Judge Collyer stepped to “decisively reject a litany of procedural objections advanced by FDA in an effort to evade review on the merits.”


In fact, Judge Collyer held that “FDA’s earlier determination on two prior occasions involving different generic drugs of the precise statutory interpretation question in Teva effectively amounted to a “rule” that constituted “final agency action” for purposes of APA review.” In other words, since FDA had already made decisions on similar issues, their guidance from those prior cases essentially became an agency law.


Although FDA’s position was ultimately upheld, Mr. Friede wondered why the agency “went to such great lengths to avoid judicial review in the first place.” He noted that in a new era of American government, which calls for transparency, continuing these guidance practices that are not reviewable by courts is an “unwise and unsound approach.” He asserted that because the “FDA is not above the law,” the agency should welcome early and active judicial review as a way of progressing the agency’s public health mandate.”

December 28, 2009

Data Mining: Fatal First Amendment Flaw in Prescription Restraint Statutes

With the recent attention of health care focusing on the use of prescription data, civil liberties attorney and Harvard Law scholar Laurence H. Tribe wrote an article titled The Fatal First Amendment Flaw In Prescription Restraint Statutes, to help explain the ramifications this issue could have for patients and the health care system.

Mr. Tribe notes how states such as New Hampshire, Maine, and Vermont have each “recently enacted laws generally making it a crime to transfer entirely truthful information about prescriptions with the purpose of promoting prescription drugs.” As he points out, these laws are neither to “prevent misleading drug advertising or labeling nor to protect patient privacy” because other rules already do so.

Instead, he notes that these new laws “are intended to prevent conversations between doctors and drug companies about the merits of different treatments -- and are designed to do so by bottling up prescription-related information at its source in the pharmacies that fill the prescriptions.” Basically, these laws prohibit “the transfer of information in order to make it harder for drug companies to locate the doctors who would be most interested in how (not by whom) the companies' products have been used.”

Prescription Data

One of the obvious reasons academic clinicians and pharmaceutical manufacturers began using the complex data from prescriptions was for drug safety. These providers wanted to “identify unforeseen problems like drug complications and rising antibiotic resistance.” In doing so, these companies, “when presented with new and relevant information, would contact doctors who are known to prescribe certain medications in order to alert them to what has been learned.” 

Mr. Tribe also noted that pharmaceutical companies use prescriber-specific data “to help them market new and alternative therapies directly to doctors,” through a process known as detailing. Not only does the prescription history data let a company target those doctors who would most want to know about the company's products, it does so without including any private information about the patient. Doctors are not forced into meeting with detailers but, usually choose to do so “because they receive useful information about current developments.” 

What makes this data particularly useful is that “pharmaceutical companies do not themselves generate the data that detailers use to locate interested physicians.” This data comes from companies who collect the prescription drug records maintained by pharmacies throughout the country. Mr. Tribe compared this data publishing practice to the way The Wall Street Journal reports on hedge fund performance -- in which the names of all investors remain anonymous, but the fund managers and the investments they make are the subject of independent evaluation. 

Ban on Data

Although the laws in New Hampshire, Maine and Vermont did not directly ban detailing, they “generally forbid data research and publishing companies from acquiring, analyzing, and providing pharmaceutical companies with such data, even when indisputably accurate, when one of the purposes of such data acquisition and dissemination may be commercial.” The laws also served to prevent “pharmaceutical companies themselves from relying on the publishers' reports as a means to tailor their marketing strategies.” 

Consequently, Mr. Tribe noted that these restrictions make “it more difficult for doctors to receive truthful information from drug companies that the states think will lead doctors to make bad prescribing decisions.” The problems with such restrictions are not offset by the rationale states use for the laws, such as cost-reduction, improved patient safety, and protecting patient privacy, because doctors are being prohibited from truthful information.

Interestingly, the problems these laws have created have been tested in court. “In New Hampshire, a trial court struck down that state's statute, but the court of appeals reversed.  In Maine, the statute has been struck down in part, a ruling that is now on appeal.  Vermont's restriction remains pending before the U.S. Court Appeals for the Second Circuit.” Mr. Tribe asserts that “these lawsuits should be easily decided in favor of holding the statutes unconstitutional.”

He reasons that the statues abridge freedom of communication and regulate speech by directly banning data researchers to publish reports of pharmaceutical relevance. As a result, Mr. Tribe uses two Supreme Court cases which affirmed the view that “obstructing access to the informational building blocks of speech is every bit as pernicious an abuse of governmental power over the free flow of information and ideas as is restricting the resulting speech itself.” 

Accordingly, he notes that the new statutes “cannot survive application of these core principles and the precedents embodying them because the transmission of the truthful pharmaceutical information itself is fully protected by the First Amendment.” Moreover, because the companies that distribute prescription history information are not proposing any commercial relationship, “their speech too warrants heightened protection because it includes extensive scientific information on matters of profound public importance.” 

The laws are also a problem and deserve strict judicial scrutiny according to Mr. Tribe because while they “try to make it harder for drug companies to contact doctors, the statutes also encourage the use of the identical information by the state itself and by health insurers to try to dissuade doctors from prescribing brand-name drugs.” Such a practice he notes has been struck down by the Supreme Court numerous times. 


Mr. Tribe uses the word of Supreme Court Justice Oliver Wendell Holmes to sum up his ideas precisely. Justice Holmes observed that, "the ultimate good desired is better reached by free trade in ideas," for "the best test of truth is the power of the thought to get itself accepted in the competition of the market," and "truth is the only ground upon which [peoples'] wishes can safely be carried out." 

As a result, if States have problems with detailing, they should devote their considerable “resources to loudly voicing that opposition and debating ways to regulate its supposed abuses -- but not to silencing the free flow of truthful information that these new and dangerous laws target.”

Since these statutes violate the core principle that the government may not restrict even commercial communication merely to block the dissemination of truth, Mr. Tribe asserts that they should be overturned and changed. Ultimately, to think that States are better “able to make prescription drug choices than are the highly trained doctors who actually know their patients and prescribe medications for them” is a serious problem. Hopefully Mr. Tribe’s insight will show patients why.


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