Wednesday, January 18, 2012

Conflict of Interest: Onus put on drug firms this time to report on financial relationship with doctors

What has recently become major news for the public regarding the government’s latest steps in healthcare reform has been an ongoing legal matter followed by healthcare attorneys for years.

I have done a lot of work with physicians and hospitals who have had to disclose their relationship with pharmaceutical and medical device companies. Now, the New York Times has published an article on a government initiative requiring the drug makers themselves to disclose their financial relationship with doctors.

For years the legal and medical community have closely followed the potential conflict of interest issues arising from a relationship between doctors and pharmaceutical companies. While the companies don’t directly pay doctors to endorse their drugs, as that would be illegal, there are other ways around such endorsements. Certain doctors are targeted to do research, publish on, and give their expert opinion and consultation on certain drugs, their side effects, and positive results. They are to be honest and objective. However, they do this while the pharmaceutical companies pay for their trips to overseas seminars, panel discussions, lodging, speaking fees, etc. The assumption is that anything short of a ringing endorsement for the drug will likely lead to the doctor not being invited back. However, the doctors argue that they are not only objective, but base their findings on extensive research and peer reviewed studies and publications. In either case, most leading institutions, like the University of Michigan’s Hospital in Ann Arbor and the Cleveland Clinic agree that such a relationship should be disclosed. These institutions have done so publicly, including on their websites. This has been an epidemic for years with news publications in the past. See the following:

The link above is a ringing indictment on psychiatrists, who the article cites as the top profiteers of such a relationship. It has listed, along with the names, photos, and bona fides, a number of psychiatrists who gained a lot financially while not disclosing their relationship with their patients or the institution that employs them. In some cases, the results of their research was also found to be extremely skewed and flawed. That was published in 2009. One of the concerns underlying this problem was that many psychiatrists who did not work for pharmaceutical companies relied on the expert opinions of these doctors and their publications in prescribing and recommending the drug to their patients.

This past year, ABC news covered a similar story in March 2011. This was an editorial that also focused on psychiatrists.

On July 2, 2011, another article was published on Harvard Doctors being disciplined for similar issues.

That focuses on how Harvard and Mass General expected, but did not heavily monitor or enforce their physicians to report such financial relationships.

Disclaimer on Assumptions: The public may read about these stories and assume that a drug company is approaching doctors and giving them money directly to promote their drug, praise it as effective, and marginalize any potential side effects. This is not true. As stated earlier, they are hired for objective research and as consultants based on their expertise. The government has now put pressure on the drug companies themselves to report since many institutions and physicians have not done so. It is also worth noting that many of these endorsements are in fact sincere and objective and not based on any financial incentive. Many physicians may actually like the drug and base their opinion on thorough research.

Practical solutions: Institutions have agreed and the government is more intent on enforcing disclosure. Regardless of intent, how do you put aside the insinuation that if a physician is a paid consultant or has any financial arrangement with a drug company that it is impossible to give a truly objective recommendation for treatment? Many respected institutions recognize the difficulty in that and have taken serious measures. One suggestion is that the consulting or endorsing physician not be allowed to prescribe the drug to any of the patients at the institution that employs him/her. Furthermore, they may refer out any patients that may be a candidate for that drug. The key is to keep both jobs separate in order to avoid conflict.

Doctors should not be prohibited from advising pharmaceutical and medical device companies. It helps for the effectiveness of such drugs and even medical devices and may promote innovation. However, disclosure of the relationship and separating the jobs as much as possible to avoid conflict of interest issues is becoming as much a legal necessity as it is a medically ethical one.

Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC

Tuesday, January 17, 2012

Bruising Piece On Declining Reimbursements Neglects Impact of Legal Counsel

An article was published earlier this month about physicians in small private practices “going broke” due to a number of factors which include the evolving healthcare system, declining reimbursements, and a lack of business acumen. This article details the changes and includes a couple of anecdotes, including that of a respected oncologist.

I am inclined to agree with most experts, citing a lack of business acumen as a leading reason for the decline. However, there is also an important element left from the piece. While the article cited a change in a few laws, it did not emphasize the lack of continuous and/or effective counsel in guiding the physicians through these changes over the decades. While business acumen is important, it wasn’t always necessary to help these practices continue to thrive over the years. On many occasions, a physician’s knowledge, expertise, and exceptional quality of treatment administered among his/her patients was more than enough to not only sustain a practice, but to help it grow and expand. It brought new business and repeat business. On the same token, no amount of business expertise, marketing advice, paid advice by consultant firms, etc. could compensate for inferior care and substandard treatment.

Granted there may be a bias that this is coming from an attorney, but physicians and healthcare institutions, now more than ever, need legal counsel! Every way that a practice is being reimbursed is subject to review and reform by Federal and state government. This even includes reimbursement for prescription drugs. The passing of the Patient Protection and Affordable Care Act is not the end of this chapter. Many of its provisions will be taking effect over the next several years and will have a major impact on private practices. Those that are constantly informed and counseled will stand a better chance of weathering the storm over those who wait until something happens and require counsel for damage control. This article is especially illustrative about how even those physicians who are well respected in their locale and medical community are not safe if they are not made aware of the changes. Many of these incidents may have been prevented with a healthcare attorney advising the practice on a regular basis.

Midwest Legal Partners, LLC

Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC