Life Science Compliance Update

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32 posts from September 2010

September 30, 2010

Cleveland Clinic’s Guy Chisolm: Physician Industry Collaboration and Innovation

Innovation 
During a recent interview, Dr. Guy Chisolm, Director of the Innovation Management and Conflict of Interest program at the Cleveland Clinic, discussed the importance of maintaining and preserving academic-industry collaboration. He clearly emphasized that this partnership benefits patients, and went on to discuss a number of ways academic-industry relationships have provided innovation and better outcomes to the public.

To begin with, Dr. Chisolm explained to Dr. Steve Freeman why AMCs interact with pharmaceutical and device companies in the first place. Dr. Chisolm explained that AMCs only generate basic, translational, and clinical science. Out of those endeavors come discoveries, and from those discoveries come the potential for intellectual property, which if it comes to fruition can benefit patients.

AMCs however, are not manufacturers of science, and in order to bring discoveries into the hands of patients for their benefit, Dr. Chisolm asserted that there has to be a partnership with industry. He also recognized that this kind of interaction between academia and industry is extremely beneficial to patients. 

A second reason why AMCs collaborate with industry is through consulting. Since faculty and staff at AMCs consume themselves with research, consulting gives companies a chance to understand what is needed in the medical world, where there are gaps in treatment and care, and what diseases or conditions should be focused on. This gives companies an idea of where there are markets and opportunities for devices and drugs, and it falls on the academics to consult them on what avenues for research are preferred. Dr. Chisolm explained that this interaction is also very beneficial to patients. 

Another way industry and academia interact that is beneficial to patients is through clinical trials. Dr. Chisolm explained that academic-industry collaboration is crucial for performing clinical trials. This partnership is essential because every innovation and drug truly advances between AMCs and industry.

The discussion then shifted from all of the benefits from academic-industry collaboration to the potential problems. Dr. Chisolm explained that if you have faculty or the AMC itself, which are benefitting from ties with industry, there needs to be caution about the decision making process. He asserted that in cases where ties exist, faculty and AMCs must ensure that making decisions is still in line with the best interests of patients, and that all data is absolutely valid and verifiable so there is no undue influence.

Despite this potential for conflicts of interest (COI), Dr. Chisolm expressed that given the many benefits from industry-academia interactions, no one in academia or industry wants to end these beneficial partnerships, and neither does the public. Instead of trying to eliminate or hinder these relationships, he suggested that a better model is more transparency about these partnerships. This will help mitigate the influence of the financial aspect of the relationships so that it does not influence data.

Part of adopting this transparent model is to end the framing bias of calling such relationships “conflicts.” He explained how calling academic-industry partnerships a “conflict of interest” is like convicting someone of something. Such a negative connotation he recognized is not necessary. Instead, he noted the correct terminology should be “innovation management” because such relationships between AMCs and industry are productive, collaborative relations. Dr. Chisolm also recognized how institutions are beginning to use the term “outside interests,” instead of using COI.  

Another function of this model, which the Cleveland Clinic has adopted, is that it does not try to hide or mask the financial relationships. It merely brings out equally the values and the potential risks of academic-industry collaboration.

In explaining the potential risks associated with academic-industry collaboration, Dr. Chisolm noted that COIs could occur when choosing what kind of drug or device to use, running a clinical trial, recruiting subjects, and the motivations behind conducting a trial (i.e. financial). However, as a recent story highlighted, the potential for COIs are not just associated with industry funding, they happen in purely academic areas as well.

Dr. Chisolm explained that in academia, you do not want to interpret data in a biased fashion because of industry involvement. Yet he recognized that it would be very difficult for an investigator in an AMC to misinterpret data because there are multiple centers collecting data. Since multiple people are handling the data, and only one has the relationship with the company, Dr. Chislom recognized that it would be a rare phenomenon with so many interactions that data could be perverted by just one of those interactions.

As a result, he acknowledged how infractions are rare. It is only because of newspaper articles that highlight these rare incidents that make them seem more prevalent. The reality is the news media are only looking for outliers because they are inherently interesting and newsworthy, which helps them sell stories. However, as Dr. Chisolm correctly pointed out, those rare infractions are not representative of what goes on, and if the public hears about a rare COI, they should recognize that.

While they may show what has happened in the past, institutions, individuals, industry and agencies have adjusted their behaviors, policies, and regulations. Dr. Chisolm noted how the people he knows in science are highly ethical. This means that when looking at these outliers in the press, people must read them with skepticism and look for corroboration of their sources.

The interview then discussed the ways AMCs can ensure that their interactions with industry are appropriate. Dr. Chisolm asserted the need for AMCs to be transparent and expose these relationships to the public so that they can answer questions from patients and the public about such partnerships. Using the Cleveland Clinic as an example of transparency, he noted how they were the first AMC to tell the public about what companies had ties to physician by using broad categories such as consulting, speaking, and education.

He recommended that AMCs should similarly develop websites and brochures for patients and the public that include the risks and benefits associated with collaborating with industry. He also noted that AMCs should be gathering information of faculty ties to industry to be looked at data by a COI committee. This committee would determine if there could be an apparent or real COI, and if so, manage it.

To measure the impact of Cleveland Clinic’s transparency, they conducted a survey last year of 1,400 patients. The survey asked questions about what patients wanted to know about doctor ties to companies. The participants were self-selected.

The results of the survey showed that the majority of patients saw the Cleveland Clinic in a positive light for willing to be transparent about ties to companies, and many felt they were handling COIs because they were being transparent about it. With respect to payments, there was a consensus among participants that payment from industry between $5,000 and $10,000 was positive because it showed that industry relied on these doctors for information the doctor knew. When payments were over $100,000, participants were more skeptical and wanted to know why so much money.

Participants also found that when physicians were making money from several different companies, they believed that doctor was on the cutting edge of innovation. When there was no money for a doctor, participants wondered if the doctor knew what was going on in his field. Overall, participants thought the ties to industry were beneficial.

The last part of the interview discussed the negative effects COI has placed on AMCs and individuals. Dr. Chisolm noted that AMCs are facing a regulatory burden that forces them to pay additional costs for resources, personnel, and infrastructure. This makes AMCs less productive in other areas like research. He touched on the recent NIH rules, and noted how NIH is aware of the beneficial ties of academia and industry, and hopes they move towards rules like innovation management.

What this means is that AMCs must be proactive about educating the public of the real risks and benefits of industry-academic ties so that we can better identify and manage the good ones, which benefit the public and patient populations. This is crucial because collaboration is so important for new products and educating doctors about new breakthroughs.

In the end, he recommended that private organizations, not the government, achieve guidelines for transparency that will help rebuild the public trust and assure them that the ways AMCs collaborate with industry will benefit them. Taking this step is important since the public, AMCs and industry does not want to end these beneficial partnerships.

ACCME-ACPE-ANCC Jointly Accredit Organizations

Medical team 
In recognition of their work to offer team-focused education that improves patient care, the Institute for Healthcare Improvement (IHI) and VHA Inc. formerly known as the Volunteer Hospital Association Inc. (VHA) received joint accreditation status last week from the Accreditation Council for Continuing Medical Education (ACCME®), the Accreditation Council for Pharmacy Education (ACPE) and the American Nurses Credentialing Center (ANCC). IHI and VHA are the first two organizations to receive this joint accreditation as providers of continuing education for health care professionals.

 

IHI is an independent not-for-profit organization helping to lead the improvement of health care throughout the world. Founded in 1991 and based in Cambridge, Massachusetts, IHI aims to accelerate improvement by building the will for change, cultivating promising concepts for improving patient care, and helping health care systems put those ideas into action.

 

VHA Inc., based in Irving, Texas, is a national network of not-for-profit health care organizations that work together to set new levels of clinical performance, identify and implement best practices to improve operational efficiency and clinical outcomes and drive maximum savings in the supply chain arena. Formed in 1977, through its 16 regional offices, VHA serves 1,400 hospitals and more than 30,000 non-acute care providers nationwide.

 

The joint accreditation status is significant because it decreases the administrative burdens for continuing education providers, as they can take advantage of one unified, streamlined process rather than obtaining three different accreditations. Organizations accredited separately can also produce education for health care teams, and organizations that are awarded joint accreditation can produce education that is not team-related. In order to be eligible for joint accreditation, an organization must:

 

-    Already be accredited by at least two of the three accreditors;

-    Its mission statement must highlight health care team education; and

-    25 percent or more of its educational activities must be designed by and for health care teams.

 

Accredited continuing education providers must meet rigorous standards for educational quality and independence – including the ACCME Standards for Commercial SpportSM. Consequently, ACCME, the ACPE and the ANCC hope that the joint accreditation initiative will assure the public that health care teams receive education that is designed to be:

 

-    Independent

-    Free from commercial bias

-    Based on valid content; and

-    Effective in improving the quality and safety of care delivered by the team.

 

The goals of this initiative are supported by the new health care reform law, which emphasizes the value of team-based care. Additionally, the Institute of Medicine’s seminal 2003 report, Health Professions Education: A Bridge to Quality, stated that health professionals need to “cooperate, communicate, and integrate care in teams to ensure that care is continuous and reliable.”

 

In response to the joint accreditation recognitions, Murray Kopelow, MD, ACCME Chief Executive noted, “Accredited continuing education for the health care team is a strategic asset to national quality and safety initiatives and contributes to improving health care professionals' performance and patient care.”

 

Echoing his support, Peter H. Vlasses, PharmD, DSc (Hon), Executive Director of ACPE, noted that, “This joint accreditation process is a ‘win -win –win’ for providers, accrediting organizations and health care professionals.” He specifically recognized that joint accreditation will:

 

-    Facilitate interprofessional learning and networking among health care providers

-    Preserve high quality standards for educational program development; and

-    Improve efficiency of accrediting organizations. We encourage other qualified providers to pursue this opportunity to support team-based, patient care.”

 

IHI Senior Vice President, Don Goldmann, MD, recognized the importance of their Joint Accreditation, and asserted that, “ACCME, ACPE and ANCC have been visionary leaders in recognizing the contribution of collaborative learning to today’s quality and safety challenges, especially in a health care environment where resources are not unlimited and can and must be used more efficiently and effectively.”

 

The concept of multiple accreditations is not new, many of the ACCME accredited organizations are accredited by multiple accrediting bodies (ACPE, ANCC…) but on different schedules for accreditation.

 

As projects such as the medical home and bundled payments begin to occur, and other reforms to the payment and reimbursement of medical care take effect, team-focused health care may have a larger role in attempting to reduce health care costs while improving efficiency and outcomes in the health care system. Team-focused health care has much promise, and a collaborative effort between doctors, nurses, pharmacists, and other health providers is often necessary in complex and chronic diseases.

 

As a result, emphasizing health care team education is a great goal for continuing medical education (CME) providers, especially given the projected shortage in primary care physicians, and large increase in number of patients from health care reform. While more and more patients enter into our system, and less doctors are able to offer direct treatment, team based health education will be crucial for handling this influx until more doctors are trained and educated.

 

September 29, 2010

Orphan Diseases Desperate for a Cure

Photolibrary_rm_photo_of_man_taking_erectile_dysfunction_pill 
There are more than 5,000 diseases designated as “orphan” because there are so few “sufferers that most pharmaceutical companies are reluctant to invest in cures.” One individual who understands that fate in a very unique way is Dr. Stephane Huberty.

Dr. Huberty, a 48-year-old Belgian doctor, has been suffering from myasthenia gravis, a rare neurological condition, for the past 14 years. As the Wall Street Journal explained, the disease affects one in 5,000 people, and is a dysfunction of the immune system, otherwise known as an autoimmune disorder. Myasthenia sufferers produce antibodies that block muscles' ability to receive nerve signals from the brain.

While there is no proven cure for myasthenia, it can be kept under control with a mix of Mestinon (a drug related to toxic nerve gas), surgery, steroids and other drugs. Treatment costs around $30,000 a year. Like with diabetes, the drugs usually require constant scheduling, and patients have to build their lives around the illness. Consequently, Dr. Huberty has been taking medication he and others developed, but he can't find investors to pay for a clinical trial because pharmaceutical companies and other doctors say his product is unproven.

In fact, Dr. Huberty decided to take “a leaf out of 19th-century science and use himself as a guinea pig,” when in late May this year, he inserted a needle into his upper arm and injected himself with a cloudy white vaccine previously tested only on rats and dogs. After the injection Dr. Huberty told WSJ that he feels better, and that the drug hasn't produced any nasty side effects. Those, he says, are “good signs that we should begin a professional clinical trial on a sufficient number of patients.”

For many patients, “taking unapproved drugs is also the last resort for those who are desperate to get access to new biological, stem-cell and vaccine technologies that are being invented much faster than regulators can certify them.”

One of the difficulties in finding “orphan drugs” is a consequence of the “laborious FDA approval process that requires drug developers to conduct four phases of trials, involving thousands of patients, which can take as long as 10 years to get a drug approved.” As one FDA spokeswoman pointed out, the agency has to be “convinced the product is safe and effective.”

Many scientists say this standard has become more thorough and demanding over the past two decades, as safety standards “have ratcheted upward,” increasing the number of patients on which a prospective drug must be tested from thousands to tens of thousands. The regulatory burden has also created a $24 billion industry world-wide in conducting medical trials, which “has made bringing a drug to market even more expensive and means many possible cures never secure the investment needed to overcome this hurdle.” And while FDA has made some progress in speeding up the approval of orphan drugs, getting them to the market is another hurdle. 

To overcome these obstacles, Dr. Huberty took matters into his own hands, similar to a previous story we covered. He began reading medical papers and came across a work by J. Edwin Blalock, a professor of medicine at the University of Alabama at Birmingham. Dr. Blalock “conceived a vaccine in the late 1980s that attacks the lymphocytes that produce auto-antibodies, and he theorized the vaccine might be able to cure autoimmune diseases.”

In the 1990s, Dr. Blalock then tested the vaccine on lab rats in which he caused myasthenia. Despite having his research funded by the U.S. Muscular Dystrophy Association and the National Institutes of Health, “he couldn't interest any companies in trying to develop and test the vaccine on humans.”

Consequently, after an initial meeting, Dr. Huberty made an offer to Dr. Blalock in 2001 to set up a company that would buy the patent for the vaccine, and to go into business together. The company, Curavac, would try to bring a cure for myasthenia to market. After establishing the company, Dr. Huberty “set about finding investors.” Eventually he was able to raise more than $1.5 million. With this funding, Dr. Huberty “hired experts in the field and outsourced the manufacturing work to a certified contracting lab in Marseille, France. After all their hard work, the drug was ready for clinical testing last year but, it would take another €5 million and a couple of years before this could begin.

Without any luck getting money from major biopharmaceutical companies, “Dr. Huberty decided he couldn't wait. Between June and August of last summer, he injected himself three times and felt cured. “He was able to swim, go for long walks and even ski. His nanomole-per-liter antibody count, a traditional measure of myasthenia gravis, fell to near normal levels, according to independent hospital records reviewed by The Wall Street Journal.” Even following a relapse, “he re-injected himself with a dose six times as strong as before, and now feels better again.”

But Dr. Huberty says “it will take €20 million and up to 10 years of clinical trials before he can sell the drug on the market.” He maintains that the “market is there” because there are 200,000 myasthenia sufferers and 15,000 diagnosed each year in Europe, the U.S. and Japan. Part of the problem getting funding, in his opinion, is that companies are not interested in curing a disease.

Once approved, “he plans to sell the cure—most likely three to five injections, possibly with a booster injection a few years later, he says—for $30,000 apiece, the same as the cost of one year of conventional treatment.”

Ultimately, with numerous orphan diseases not receiving adequate attention or funding, Dr. Huberty’s story demonstrates the length at which individuals must go not only to save their own life, but others as well. While the financial support may not be available now, Dr. Hubert is “ready to do whatever it takes to help sufferers of myasthenia gravis.”

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