Monday, April 28, 2008

No pharm pizza for doctors

The Association of American Medical Colleges came out with recommendations today that would ban all pharmaceutical company gifts to physicians and medical students, including items as inexpensive as pizza lunches for a doctor’s office.

Let me explain why banning pizza, pens, post-it-notes, and other "chachkes" for doctors won't accomplish anything. First of all, doctors and medical students should know better than to eat high cholesterol pizza. Secondly, it's not only one drug company that buys pizza for the doctors - every pharmaceutical company that has competing products buys pizza for the physicians and office staff - so the net result is no one company has an advantage in influencing doctors because they all buy the pizza! Perhaps the one that orders extra pizza toppings wins? (I'm partial to mushrooms if any pharma reps are reading this). If you think that banning pizza universally will reduce the cost of pharmaceuticals for consumers, then you've got your head buried in pizza dough. Drug companies will simply use the pizza savings for other forms of marketing like more extravagant booths at medical meetings, more distribution of peer-reviewed articles for off-label marketing, and more eDetailing. So, unless the government bans all pharmaceutical marketing by all companies there will be no net savings, merely a transfer of funds from one form of marketing to another. Additionally, the medical schools need to be careful about what they wish for since many of them receive up to 16% of their funding from pharmaceutical companies as revealed by this NPR survey done in 2005:

So if doctors and medical students shouldn't accept pizza, then the medical school shouldn't as well. Right? Also, medical schools receive a great deal of funding for their Continuing Medical Education activities from pharmaceutical companies. See this report "Medical schools and societies saw the highest commercial funding increase of any of the provider groups, drawing 8% and 7% increases, respectively." So medical schools should not accept CME funding from pharmaceutical companies - right?

And, in a study published in the Journal of the American Medical Association in October 17,2007, it was found that "two-thirds (60%) of department chairs had some form of personal relationship with industry, including serving as a consultant (27%), a member of a scientific advisory board (27%), a paid speaker (14%), an officer (7%), a founder (9%), or a member of the board of directors (11%). Two-thirds (67%) of departments as administrative units had relationships with industry." See the full article at So, all medical school department chairpeople should give up all of their pharmaceutical industry associations as well. Right?

'What Doctors Think' performed an online physician survey of 230 USA doctors in various specialties in January 2008 to determine what their views were on pharma and medical device company marketing. 60% of doctors believe that physicians should not accept any gifts from pharma reps, but 72% said that phsyicians were not improperly influenced or coerced by any gifts given. 55% of doctors were in favor of pharma companies being required by law to publicly post all gifts to physicians. The complete survey can be viewed at

In summary, to be fair, if you end pizza gifts to doctors, as per the recommendations of the Association of American Medical Colleges, then you should stop pharma from contributing ALL funding to medical schools. That would be a mistake since many schools derive great benefit from pharmaceutical company grants, funding, donations and other gifts. All that money would probably wind up being spent in DTC ads if they weren't given to doctors and medical schools. I'd rather eat pizza than see more DTC ads.
Robert Cykiert, M.D.

Sunday, April 27, 2008

FDA focuses on LASIK

LASIK is an excellent procedure as proven by millions of satisfied people who’ve had this procedure done in the USA in the last decade. A recent worldwide review of literature on LASIK revealed that there is a 95% satisfaction rate with the procedure
That’s why NASA has aproved LASIK for astronauts and other branches of the military have approved LASIK for people in the armed forces. However, no procedure is perfect, and there are always risks to any surgery, just as there are risks to driving a car or flying in a plane (although those risks are not told to people who buy cars or fly in planes – it is assumed by the auto and airline industry that travelers know that).

The FDA has apparently received 140 complaint letters from patients in the last 8 years citing various forms of dissatisfaction with their LASIK results. Before we discuss dissatisfaction with LASIK, we must define what we mean by dissatisfaction. The media has devoted much coverage to the FDA-LASIK story this past week, but most of it is in the form of short anecdotes where there is not enough time to discuss important details – as seen on my CBS News Interview from April 24, 2008

There are several possibilities for why patients may not be satisfied with the results of their LASIK procedure. Some of these are preventable and some are not. The 1st type of dissatisfaction is a poor result due to laser or equipment malfunction. This is extremely rare with current state-of-the-art laser technology, but can occasionally occur. If the malfunction occurs because of improper maintenance of equipment, then that is preventable, however, if the malfunction occurs unpredictably, then that cannot be avoided. Fortunately, equipment malfunction because of poor maintenance is extremely rare in the USA, and unpredictable malfunction is rarer.

The 2nd type of dissatisfaction occurs because of less than meticulous pre-LASIK screening of patients. There are multiple parameters that must be evaluated before a patient is determined to be a good candidate for LASIK. These include the degree of nearsightedness, farsightedness and astigmatism that requires correction, the curvature of the central and peripheral cornea and the expected postoperative corneal curvature, the corneal thickness, the pupil size in light and dark environment, the degree of dryness of the eye if any, and several other eye health and systemic health criteria. If all the preoperative parameters for LASIK are carefully and meticulously evaluated preoperatively, then inappropriate candidates can usually be excluded with great certainty.

The 3rd type of dissatisfaction may occur because of a poor result due to surgeon error during the procedure. This is also a very uncommon event since surgeons go through elaborate training to be certified to perform LASIK, however, very rarely surgeon errors can occur even with highly experienced surgeons who have performed hundreds or thousands of LASIK procedures.

The 4th type of dissatisfaction stems from patients having unrealistic expectations from LASIK. I have come across patients who expect to see golf balls 350 yards away after having LASIK, and 50+ year-old patients who expect that they will be able to read without reading glasses after correction of their distance vision via LASIK. The latter is not possible because everyone in that age group has presbyopia, and requires reading glasses if their distance vision is fully corrected in both eyes with LASIK. Some patients have the unrealistic expectation that their vision can be guaranteed to become 20/15 or 20/20 (without glasses or contact lenses) after LASIK. While in the vast majority of cases this is achieved, because of biologic variability of corneas and their reaction to laser light, some patients will only achieve 20/25 or 20/30 vision from LASIK, and some will need a second or enhancement procedure to fine tune their vision. Patients with unrealistic expectations can be screened out before they have LASIK by having lengthy, detailed discussions with them prior to the procedure to make sure they understand what LASIK accomplishes, and that guarantees are not possible.

A 5th form of dissatisfaction can arise in the extremely rare event where a patient is a perfect candidate, the procedure is done perfectly by an experienced surgeon with the latest highly maintained equipment, yet the patient has less than optimal results because of idiosyncratic healing of their eyes after LASIK.

All 5 forms of dissatisfaction discussed above are covered in a LASIK consent form which every patient should read carefully and discuss with their surgeon preoperatively. It has been my experience after 12 years of performing LASIK and Laser Vision Correction, that if the appropriate meticulous preoperative screening is done, if the latest state of the art equipment is maintained properly, if the procedure is done by an experienced surgeon, and if the patient is educated regarding proper expectations from LASIK then the LASIK satisfaction rate approaches very close to 99+%.

Nothing in medicine is 100%. I think that the FDA panel will find this as well.

Robert Cykiert, M.D.
April 26, 2008

Thursday, April 24, 2008

Chantix: Friend or Foe for cigarette smokers?

Chantix was approved by the FDA in May 2006. It's a unique drug manufactured by Pfizer that helps smokers get over their cigarette addiction:

However, in Novemeber 2007 the FDA warned that some people who take Chantix become agitated, depressed and even suicidal:

The Associated Press has publicized this by reporting on a patient with severe depression from Chantix on April 23, 2008:

I think we’re losing sight of the real issue by being myopic about Chantix. The real culprit is tobacco, not Pfizer or Chantix. Chantix was created to deal with the severe physical and psychological addiction caused by tobacco/nicotine. Tobacco is the leading cause of cancer and heart disease in the USA, and probably the rest of the world. Tobacco kills more than 400,000 people a year in the USA according to US Government/CDC statistics:
To put that in perspective, think of this shocking statistic: Tobacco kills 100 times more Americans every year than have been killed in the Iraq war in the last 5 years. Yet, for some strange reason there is very little, or no media attention to the 400,000 avoidable annual casualties at home. Why is that? Any mortality or morbidity from Chantix should really be attributed to tobacco as well.

It’s time that the government banned all marketing and advertising of tobacco products. There’s no excuse for banning tobacco TV ads and permitting advertisements in magazines, billboards, direct mail and other venues. For those who argue that there is a First Amendment right to advertise tobacco, please remember that there is also a Sixth Commandment: Though Shalt Not Kill. In this case the Commandment wins over the Amendment.

The media should also help spread the word about tobacco. Oprah, as a public service, should have an anti-tobacco show at least once a month till the tobacco companies are embarrassed and humiliated into stopping ALL tobacco advertising in the USA and internationally. People who have side effects from Chantix or have tried to commit suicide from Chantix can also appear on Oprah to emphasize that this is a tobacco related problem. She should invite guests with tobacco-related heart disease, emphysema and lung cancer on the show who can tell their cigarette induced horror stories. MTV should have a similar program once a month. MySpace and FaceBook should have anti-tobacco ads on each of their millions of web pages so that they can get the message across to the next generation. Stopping all tobacco advertising in the USA will also single-handedly reduce the USA healthcare budget and Medicare expenditures more than any other cost saving program!
Robert Cykiert, M.D.
April 24, 2008

Tuesday, April 22, 2008

Who's right? The FDA or the AMA?

The AMA, in a commentary in its Journal of the American Medical Association,, announced that it is against the FDA's recent preliminary ruling that allows pharmaceutical companies to distribute peer-reviewed literature to doctors regarding off-label use of medications It’s odd that the AMA does not trust practicing physicians to evaluate peer-reviewed literature from respected medical journals in the process of discerning whether a pharmaceutical is effective in managing a disease state. After 4 years of college, doctors go to medical school for 4 years and then do 3-7 years of additional training as interns, residents and fellows to become competent physicians with good judgment. Does the AMA think that an article distributed by a pharmaceutical rep will sway a physician to prescribe a drug incorrectly, or for a condition that it was not intended for? Doctors have sufficient common sense, knowledge and experience to realize that one article from a journal does not make gospel, and we all know that for every article making a point there is another article that disputes the point. We also know that pharma reps are obviously biased to some degree, and we realize that before we use a medication off-label we need additional ample evidence in the form of other articles, lectures and communications with colleagues. Physicians don’t need blinders. The more communications we are exposed to, the more likely we will make the right treatment decisions for our patients. The FDA is right on this one.
Robert Cykiert, M.D.

Sunday, April 20, 2008

Vytorin and Cholesterol Conundrums

In recent months The New York Times,, and Wall Street Journal,, published many articles on the controversial Vytorin -ENHANCE clinical trials and the possibility that Vytorin and Zetia were not effective in reducing carotid artery (and coronary artery) plaque, even though they were effective in reducing serum cholesterol. If lowering cholesterol does not reduce coronary artery plaque, then there may be a fallacy in the entire theory that reduction of cholesterol leads to reduction of heart attacks. Or more likely, the ENHANCE study may have not been designed properly since the group of patients that Vytorin was tested on had a genetic, familial disorder that caused elevated cholesterol, and the patients were pre-treated for elevated cholesterol prior to ENHANCE. The genetic disorder may also account for variation in plaque distribution and growth in the surrogate carotid arteries that were studied in the ENHANCE trial. In view of that, correlating the results of the ENHANCE study to the average patient who has elevated cholesterol secondary to age, being overweight, having a poor diet and leading a sedentary life style, may not be valid. Our healthcare marketing research in the form an online physician survey of cardiologists
reveals that 68% of cardiologists believe that the group of patients that Vytorin was tested on was not reflective of the average patient who has non-familial elevated cholesterol (see questions #8). However, cardiologists have ambivalent feelings towards Vytorin since there was a 10% reduction in the number of cardiologists who would use Vytorin for themselves or family members after the ENHANCE study was released (see questions #12-13). In summary, it seems like the debate is dying down on whether the ENHANCE study was an accurate gauge of whether Vytorin works as it should or is advertised. It seems like all the parties involved (Schering-Plough/Merck, cardiologists who ran the study, American College of Cardiology expert panel, FDA, Wall Street analysts) were less than competent at times, had occasional conflicts of interest, and were sometimes influenced by their egos rather than facts. The real issue will probably boil down to whether Merck and Schering-Plough delayed release of data to hide something or whether the data was so poor that it could not be objectively evaluated to draw significant conclusions. I suspect the latter. Time will tell as the IMPROVE IT study,, due in 2012 will reveal whether Vytorin and Zetia reduce the incidence of heart attacks and strokes in the study population. Even then, the study population for these drugs will be questioned.
Robert Cykiert, M.D.

Electronic Medical Records - EMR

Now that Microsoft, Google and RevolutionHealth are all getting into the EMR business, many people are concerned about the safety and security of their health records online, and whether they should place their records online. EMR is inevitable. The question is who will control it. The technology required for safeguarding protected information is available, but has to be applied properly. If Google and Microsoft want to be the storehouses of EMR then they will have to deal with HIPAA just like doctors, hospitals, clinics, etc. Otherwise, all of Britney Spears’ records will be online for the whole world to see. Currently patients upload their records to HealthVault so Microsoft is technically exempt from HIPAA regulations since patients are not bound by HIPAA laws, only healthcare providers are. However, if Microsft’s and Google’s partners (Mayo Clinic, Johns Hopkins, Columbia Presbyterian) upload records to Microsoft’s servers then Microsoft will be required by federal law to sign HIPAA agreements with these medical institutions which are already HIPAA-regulated. The security and privacy systems can and will be instituted once these organizations upload medical records. And, they will be safe. When was the last time your bank account or credit card account was broken into on Citibank’s or American Express’s servers? By the way, current paper medical records have almost no security at all. Ask the cleaning and maintenance people who have access to them on a daily basis in hundreds of thousands of doctors’ offices all over the USA. Online EMR can certainly be more secure than that. ‘What Doctors Think’ performed healthcare market research in December 2007 on the subject of EMR. We performed an online physician survey of nearly 500 primary care physicians scattered across the USA to find out their views on EMR and HealthVault. The results can be found at sults
In question 20 we asked doctors which EMR vendor they would be most comfortable with. Microsoft won with 23%. The federal government came in with 13%, WebMD was third with 11%, and Google was fourth with 9%. However this survey was completed before Google’s announcement a few months ago. Personally, I believe that Medicare should create a Universal online EMR that should be used for every Medicare patient. Since virtually every senior citizen and physician in the USA is in Medicare’s billing/financial database, building an EMR on top of that would not be an insurmountable project. Ultimately a Medicare EMR that every physician and hospital had access to, and that patients would be required to join as part of receiving Medicare benefits, would save the government tens of billions of dollars over the years and would save the entire Medicare System from collapsing in the long run. The Medicare EMR could then serve as the template and basis for EMR systems used by non-Medicare patients as well, operated in conjunction with Medicaid, private insurers, HMOs etc. The current fragmented system with literally hundreds of different EMR companies selling systems to doctors and hospitals that don’t “talk” to each other is wasteful and will cost billions to overhaul in 5-10 years. All of the millions of dollars in federal and state government grants currently being dished out to test various EMR systems is also counterproductive. The only EMR that will work efficiently, benefit patients and save tens of billions of dollars is a universal, online system. Microsoft and Google are on the right track but haven’t figured out the details yet. Additionally, MSFT and GOOG are marketing to consumers instead of doctors. This is a backwards approach as well since doctors have access to thousands of records that they can upload to servers, whereas patients can only upload one at a time, and most patients don’t know what’s important to upload and what’s not. Perhaps MSFT and GOOG don’t want to deal with doctors because that forces them to deal with HIPAA laws. It’s unavoidable if they want to be players.
Robert Cykiert, M.D.

Who cares what doctors think?

Doctors directly influence more than a third of the entire USA health care economy. Consider these important facts:

  • 902,000: number of physicians in the USA in 2005
  • $2.1 trillion: USA healthcare expenditures in 2006
  • $274 billion: sales of physician-prescribed medications in 2006
  • $587 billion: cost of various patient services and devices ordered by physicians and healthcare providers in 2004

Doctors directly control nearly $1 trillion in USA healthcare expenditures, and act as the foundation of our health care system. Doctors influence millions of patients to spend billions of dollars. Doctors have huge personal purchasing power since many are also entrepreneurs with substantial incomes, and doctors typically require sophisticated equipment costing thousands to millions just to equip a single practice.

Doctors are also enormous connectors! Many teach in universities, all require continuous medical education, and typically work through hospitals where they interact with a variety of people and companies unequaled by any other profession.

Whether you are doing market research on medical devices, pharmaceuticals, medical education or on other healthcare issues, doctor survey results will help you make the right business decisions.

We help you reach out to the doctors who are your most important customers, and you can gain priceless information at an extremely low cost. When you conduct doctor surveys, you gain insights that reveal trends shaping the medical industry and your business. You may also get new customers, since cleverly designed surveys can also be used to influence physician thinking about your company, products and services.

Can you think of a more influential group in society? What doctors think really matters!