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!