Diary: Cleaning Up Clinical Research and Medical Practice Guidelines

We should all start with ourselves. We always hear the phrase, "Oh, that's not so bad". We often hear how one wrong is justified by citing another much more egregious wrong. I, too, as a physician have made a conscious effort to "completely cut-off any ties to pharma". That's a daily and continuing challenge, however, because pharma is so firmly entrenched (often ever-present if you are an employee) in medical practice.

Physicians should categorically not be a party to ghostwritten "research" publications, ghostwritten "CME", ghostwritten medical practice "guidelines", and ghostwritten DTC � ��"advertising� �� , i.e., brainwashing of the public which now goes far beyond subliminal cues. There's a very substantial paper trial in place which will now be very difficult to hide. There are many C.V.'s of esteemed � ��"experts� �� on the internet which list dozens, sometimes hundreds of � ��"research� �� publications. These publications invariably cite as authors every member of the � ��"study group� �� involved in performing the � ��"research� �� . Many of these ghostwritten publications are still cited today as if they represent legitimate research. The medical journals rarely, if ever, retract these publications.

Ghostwritten clinical � ��"research� �� papers and corrupt medical practice � ��"guidelines� �� also influence our law makers. This often results in a vicious cycle which undermines public health and depletes the U.S. Healthcare budget. Pharma, WHO, EMEA, CDC, and FDA, have apparently persuaded our legislators that it is better to � ��"hurry up, do something� �� than it is to � ��"first, do not harm� �� . This may be setting a very bad precedent. Giving preference to political expediency over proven safety and efficacy sets the bar at a new all time low.

There's an unholy symbiotic relationship that has been in place for a very long time: the medical ghostwriting results in undeserved publications, which result in academic sinecure, which gives gravitas to the medical ghostwriting, and so on. Pharma's "crime spree" will continue until the unholy symbiotic relationship with medicine is disclosed and condemned.

Pharma has become very adroit at use of indirect transfers of value and use of surrogates. By outsourcing certain high risk aspects of their franchise, pharma is able to insulate itself from lawsuits. Once faced with the inevitable lawsuit, pharma has already budgeted for a settlement. They simply write it off as a cost of doing business and continue in their criminal activity. To date, this formula has reaped tremendous profit for them.

A strong argument can be made that an unintended consequence of the conflicts of interest created by the Bayh-Dole Act and PDUFA (� ��"Prescription Drug User Fee Act� �� ) is the loss of integrity of clinical research in this country.

Physicians who follow the company line get rewarded with perks of all kinds, not the least of which include academic sinecure. Physicians who � ��"go rogue� �� , often get cut off at the knees by pharma through use of lawsuits, fear of lawsuits, and � ��"peer fear� �� . From first-hand personal experience I can tell you that use of fraud, fear, extortion, and concerted action, are major tools of their enterprise.

In the U.S., pharma's crime spree will continue until the U.S. Department of Justice uses the � ��"ultimate sanction� �� with pharma - a felony conviction that would render a company's drugs ineligible for reimbursement by state health programs and federal Medicare. David Evans' use of the phrases "crime spree" and "ultimate sanction" was prescient in his Bloomberg article of November 9, 2009. See:
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA

How do these drugs gain expedited market approvals in the first place? Illegal off-label marketing by pharma is just a � ��"spin-off� �� benefit derived by pharma for gaining expedited market approvals under the PDUFA.

Many of these expedited new drugs and biologicals are simply � ��"me-too� �� drugs which only serve to deplete the U.S. healthcare budget. Some are actually dangerous drugs, left in the marketplace, even after significant safety signals are noted. There must be a better system of checks and balances. Pharma's apologists routinely use the word � ��"innovation� �� in conjunction with the now endless parade of expedited new drugs, biologicals, and devices, e.g., � ��"innovative� �� RFID chip implants. The implicit assumptions that all innovations are universally good for society, and that society can afford them, are seriously flawed.