Monday, August 08, 2005

Medical ethics tunneling through earth's mantle, heading straight for the core

In the Seattle Times yesterday, I was quite literally stunned to see the article "Drug researchers leak secrets to Wall Street".

This story represents the culmination of an ever-increasing fall in medical ethics, replaced by moral relativity and rationalizations for the inexcusable. Medical ethics are tunneling through earth's mantle, and heading straight for the core (and perhaps out the other side).

I recall in medical school in the late 1970's that ethicist George Annas taught my class (Boston University School of Medicine class of 1981) that only bad consequences would come from concentrating on money; that income would take care of itself and our primary concern should be the patient. At the time, I dismissed this as socialist prattle, thinking my colleagues and I would know better than to be corrupted by temptation. Ah, the days of youth and idealism....

At Merck & Co., Inc., corporate ethics called for "avoiding impropriety or even the appearance of impropriety", and to follow both the letter and the spirit of the law, making decisions regarding "gray areas" by the "acid test" of what we would be comfortable with in print or other public media. Those were wise words indeed ...

Assuming this is true, here are the issues as I see them:

(1) Today, it seems many physician-scientists' concerns regarding impropriety (or even the appearance of impropriety) can be alleviated by a green substance administered in non-homeopathic doses. This green substance is certainly not listed in The Merck Index, the (not-for-profit) encyclopedia of medicinal chemistry whose authors I once managed, except perhaps on a sticker bookstores might place on the cover page.

(2) Statements that selling information about drugs undergoing clinical trials to high-paying speculators (e.g., hedge funds) "serves a clinical purpose" is a rationalization for lining ones' pockets.

(3) When the clinician has signed a confidentiality agreement, then by even talking to major investment companies, they are literally dancing on the precipice of impropriety. It does not take much for some to push them over the edge. If the organization where the clinician works has signed the confidentiality contract, the issue is murkier; however, that "appearance of impropriety" problem rears its head very hard at $5,000+ per day of chats to investors. (The public may think the term 'bribe' is a more accurate term for this level of compensation. Merriam-Webster definition: 1. money or favor given or promised in order to influence the judgment or conduct of a person in a position of trust; 2. something that serves to induce or influence.)

Of note, the honorarium for, say, critical scientific evaluation of incoming grant proposals at NIH (which is actually hard work) is something like two hundred dollars for an 8-hour working day. Clinicians should approach talking to investor and speculator groups for high dollars with the utmost of caution. Personally, I'd avoid it like the plague, but that's my own opinion.

(4) While the information "sold" by clinicians might reflect their isolated opinion(s) on a drug undergoing testing, and might lead investors in the wrong direction as easily as the right direction, there is the possibility - especially in clinical trials going very well or going very poorly - that an additive effect could give private investors (a.k.a. privileged speculators) an edge. By doing so, the sellers of the information are giving those investors a potential advantage over the common (a.k.a. non-wealthy and non-connected) investor that is destructive to truly free markets. This hurts us all. Justifications that such information "might have little likelihood of being correct" are ethically irrelevant if the information is deemed confidential by contract. To use a somewhat extreme example, it does not justify shooting at passers-by to one's home by saying that "my aim is so poor that I'm unlikely to hit anyone."

When the clinician-salesperson actually has direct access to priviliged RCT information such as blinding, adverse events, or partial results, the transgression of ethics is ever more egregious.

(5) Where there's smoke, there's fire. Just how widespread are these practices?

(6) The statement that "drug company executives know about the practice but can't crack down on the doctors they rely upon for conducting patient testing" makes one wonder if the real situation is that pharma "won't crack down", i.e., it makes one wonder if a quid pro quo contaminates clinical trials. You do the trials, we look the other way whenever you get lucrative opportunities to 'talk to investors' [for $500/hr or $5000/day].

(7) This possibility also raises the question -- on what other issues in the conduct of clinical trials do pharma companies "look the other way?"

(8) Such activities further harm public confidence in clinical researchers and the pharmaceutical industry (assuming public opinion could go much lower).

(9) If as this article claims there are "60,000 doctors" engaged in this process, that represents a pretty high percentage of doctors involved in clinical trials. It also represents a significant % of doctors in practice in the U.S. That is very, very disconcerting regarding the effects of the commercialization of medicine.

(10) Ultimately, a lot of people pay for stock market fraud either directly or indirectly. This is not a "no-victim" or "it just hurts the rich" problem by any means.

(11) Claims that clinicians "were hounded" by investment companies for information are not going to be received well by the Vioxx, Fen-Phen etc.-tarred public as an excuse for giving in and taking fees-for-information. I used to get calls soliciting me for information of one type or another at Merck. My simple response: "sorry, can't talk, company confidential, good bye."

(12) Claims that a clinician doesn't know how the information they sell will be used or care about it strike me as cavalier. The public will not react well to such attitudes.

I've now listed twelve thoughts on this issue. I can think of others, but I think my point is made: physicians are selling out to speculators for high 'fees' that would be construed by many as bribery.

Medicine needs a strong dose of what Dr. Annas prescribed so many years ago to a class of very idealistic medical students.

-- SS
Seattle Times investigation found at least 26 cases in which doctors have leaked confidential and critical details of their ongoing drug research to Wall Street firms.

The practice involves doctors at top research universities from UCLA to the University of Pennsylvania, and powerful financial firms including Citigroup Smith Barney, UBS and Wachovia Securities.

In 24 of the 26 cases, the firms issued reports to select clients with detailed information obtained from doctors involved in confidential studies. The reports advised clients whether to buy or sell a drug stock.
... Until now, the selling of drug secrets has been hidden from securities regulators and the public, but biotech and Wall Street insiders said the practice is widespread. "Everybody does this.... It's now common practice," said the chief executive of California biotech company Valentis, Ben McGraw, a former Wall Street analyst.

... The practice of selling drug secrets, The Times found, is being driven by hedge funds, the largely unregulated investment pools that cater to the super-rich. Hedge funds can make money with aggressive strategies that exploit quick price swings in stocks, and the volatile biotech industry provides many such opportunities.
... Matchmakers typically pay doctors $300 to $500 an hour to talk to elite investors. Some doctors said they can make tens of thousands of dollars a year from such talks. [is 'bribe' a better term for these payments? The public may think so -- SS]

... Such information is so valuable that elite investors pay up to $1 million a year to firms known as matchmakers, which pair Wall Street firms with doctors involved in ongoing drug research. Gerson Lehrman Group, the largest matchmaker, claims to have 60,000 doctors available to speak to Wall Street, double the number from three years earlier.