Pharmalot... Pharmalittle... Good Morning

E-records recruitment is a great idea. It will save any given pharma company hundreds of thousands of dollars/year that would be otherwise be paid to study coordinators for painstakingly combing through patient charts looking for eligible subjects.

How is e-records a good idea? Not many Americans realize study coordinators are combing through patient's charts i.e. their medical records looking for eligible subjects to a trial that they don't even know about! Now you are going to have hospitals turning patient records directly over to pharmaceutical companies! Whatever happened to privacy? Considering how trials are regulated in this country- patients should have the right to opt in and be very wary while doing it.

Anonymous, I can assure you that adequate HIPPA protections are in place even during the chart review. You seem to be saying that patients should give informed consent PRIOR to chart review. The reality is that for any given protocol, the vast majority of candidates are excluded at the chart review stage. Prior consent would worry most patients needlessly. Besides chart review often occurs before an actual protocol is in place. The investigator is just gathering patients in advance that may be more likely to qualify for a study in his/her area, based on past studies. This is a PRE study activity. Informed consent is only necessary once a study protocol has been written, since a basic element of the IC is a description of the study procedures themselves.

so, how much will the hospitals make for selling our information? and HIPAA only works to keep you from finding out how your friend is doing in the ED - other than that it's a false security. anonymous is right, we should be able to opt-in if we want to participate.

I do believe clinical research much like marketing should be an opt in situation prior to a chart review. That hospitals and physicians should ask patients if they want to be considered for clinical trials and only those charts should be used in initial screening. Medical information is sensitive and should be treated that way. The crux of the entire EMR and HIT argument- who owns your medical information.. and at the end of the day that should be you - the patient not the provider.

Whenever you fill out forms in the doctor's office consenting to release of your medical information to a third party, most people think that means just insurance companies, but absent specific prohibition of release of such information to a pharmaceutical company, any third party can see the data as long as HIPPA is observed.

In many pharma companies it is common to get charts, pharmacy data and mailing lists from providers when one of the branded products is about to go off patent, so that patients could be offered discounts and warned about the hazards of generic switches for certain classes of drugs in order to maintain brand loyalty.

Who doesn't want to save patients money and improve compliance and safety? I thought that was called doing well by doing good.

Vet writes:

"In many pharma companies it is common to get charts, pharmacy data and mailing lists from providers when one of the branded products is about to go off patent, so that patients could be offered discounts and warned about the hazards of generic switches for certain classes of drugs in order to maintain brand loyalty."

Wow. This will come as news to many people.

Mailing lists from providers for discounts seems to fall specifically into marketing. It is about time for Congress to come up with strict usage delineations and protections for medical information to reign in insurers, providers and pharma companies.

Dear Anonymous. Remember also that pharmacists are also key providers, and in fact one of the larger providers of patient data. Pharmacies and pharmacists are regulated by the states, not Congress. If you want to change things then you will have to start overturning laws state by state. Courts have repeatedly upheld the loegal rights of companies such as IMS to purchase these databases and sell them to drug companies.

JiM, I worked on several Narrow Therapeutic Index drugs, which if switched to a generic when the branded drug went of patent could be hazardous to the patients' health. Furthermore, in states like New Jersey, there are passive consent laws, which means that the pharmacist may automatically switch the patient to a generic unless the patient verbally instructs the pharmacist not to do so. Since doctors can't always be counted on to write "Dispense as Written", or "Do Not Substitute", it is the role of the drug company to proactively warn patients about dangers of such generic switches. This is not marketing; it is a matter of public health.

Re: Vet's comment, "This is not marketing; it is a matter of public health," I would offer the following invitation:

As a result of litigation, we are always seeing internal correspondence that does not make companies like good.

I would _love_ to see a record of internal correspondence which documented a company's concern about losing exclusivity essentially for public health reasons. Genuinely.

If there is such a record, I would include it in my syllabus. Guaranteed.

Pharmavet, before you get everyone riled up about the need for congressional investigations, I think you might want to check a few facts. I'll admit that my experience is dated somewhat - I left the marketing/marketing research part of the industry in 1997 to attend medicald school. Nevertheless, IMS never collected individually identifiable PATIENT information. Prescriber information, yes; patient information, no. There are survey companies which collect household information, and from these it is possible to identify households where specific medications were used, or whose members had specific medical conditions. Now the targeted direct marketing companies in the internet realm can identify potential targets by looking at the cookies accumulated from visiting various websites. Additionally, some PhRMA companies have collected patient information in the process of consumer offers - such as coupons/rebates, or registration on sponsored websites. If the consumer reveals the health information voluntarily to a commercial interest, it is not a HIPPA violation. It is not necessary to wade through charts in violation of the law to collect patient information (This does not stop ambitious reps from "assisting" doctors - typically specialists - in identifying patients who might be good candidates for their great new drug/formulation. If anyone knows of such a case, it would be in their best financial interests to contact a Qui Tam lawyer and/or their local federal prosecutor.)

Health plans/insurers can presumably use health claims information to deliver "important" targeted messages to specifically members based on clinical criteria. More often than not, health plans do not proactively reach out only to persons who may be currently affected by a policy change - but send out a general announcement to all covered members. Often though plans will encourage enrollment in case management/disease management/health coaching programs - which are a precisely targeted subset of patients who can be targeted for special messages/attention. Certainly, healthcare professionals (such as mail-order pharmacists) have previously contacted prescribers to request therapeutic (or even equivalent brand) substitutions.

On a separate matter, I used to buy the "narrow therapeutic index" argument for phenytoin, warfarin, and digoxin (before medical school). Then a few things happened: the manufacturer of phenytoin changed the formulation (and delivery kinetics) without really telling anyone about it. Some patients clearly suffered, but many others did not. Still it represented a callous disregard for the argument by the manufacturer in preference to extending exclusivity (and higher revenues). Warfarin production tolerances seemingly improved, and I came to understand that INR is as profoundly affected by patient diet, concommitant medication use and adherence as it is by who makes the tablet. For digoxin two things happened - 1) we found out that if you take if for CHF you feel better, but die sooner, and 2) the brand name has historically been pretty inexpensive.

Knowing what I know now about patient adherence to medications treating chronic conditions, the variability of kinetics based on dietary factors, drug-drug interactions, and changes in metabolism over time, I'm not very concerned about insisting on a specific brand name. Mostly, I just want the patient to receive the medication everyday as directed. In fact the only medication that I really have a preference for a specific manufacturer's product (in limited cases) is a short acting beta-agonist which has a dose counter. My preference for the dose-counter is because no asthmatic should need to use albuterol every day - and it is impossible to tell how much medicine is left without the counter.

On the "narrow therapeutic index" argument, Warner-Lambert used it to argue against generics. Around the same time, they were convicted for repeated manufacturing defects in their branded Dilantin. Health Research Group noted the irony at the time, and described the WL Dilantin situation as the most corrupt they had encountered to that date.

Here is the link for the HRG release:

http://www.citizen.org/publications/publicationredirect.cfm?ID=5555

Sid Wolfe concludes:

"In all of the years of following drug recalls, I am not aware of any company which has had so many recalls involving such a large number of bottles of pills pulled back from the channels of distribution. It is time for more vigorous enforcement by FDA and a strong message to consumers that brand name companies such as Warner-Lambert--many of whom have bent over backwards to denigrate the poor quality of generic drugs--should look in the mirror at themselves.

11/29/95"

In case some of you missed it, Pfizer put people with epilepsy at a much greater risk from switching products than any generic drug maker might have. This is because- by switching to a generic we would have known to watch out for dangers and attempted to titrate safely.

1) They did not inform patients, doctors, or pharmacists when they reformulated Dilantin in late 2007. They simply replaced the product with no warning. With no concern for safe titration.

2) They kept the same name as the innovator- rendering the DAW pointless.

3) They called it "New Look" as if that was the extent of the situation. And despite what they say- we were told it was only the appearance. I spoke with them personally on the phone. I suppose you can choose to believe me or not.

4) They did it all with the blessing and participation of the FDA via CRADA. FDA stating in their report "There is a need within the regulatory community and the pharmaceutical industry for case studies that put these principles into action and test these approaches." They did research using a NTI drug. It isn't the first time research has been conducted using epileptics- but WTH century is this?

5) DOJ didn't give it as much consideration as it would the medication you give to your dog (them taking on a bad dog product, shortly after, made my heart sink and allowed me to know my station in life long before I lost my house)- even though people with epilepsy are protected under the ADA. For all that's worth.

6) The Epilepsy Foundation (funded in part by drug companies) was removing our posts.

7) Eventually Pfizer released a statement online (about 10 months later)- impossible to find if you weren't digging- stating that doctors might want to watch our blood serum levels after all.

8) One of my Senators had the gall to reply by lecturing me on the value of generic drugs. Seems that was all he could grasp of the situation because I mentioned The Office of Generic Drugs.

I would prefer the pharmacist had handed me another generic, as "New Look" Dilantin was approved by The Office of Generic Drugs, and because we did not know it.

The pharmacists I went to in looking for some Dilantin Kapseals didn't even know they had something different on their shelves. When I asked if they had any of the Dilantin Kapseals left, they said... the brand name Dilantin? I said, well yeah, they are both brand name, but Pfizer changed the product. Some seemed truly surprised when they opened the new bottles to check. Some made phone calls. All were apologetic that they could do nothing to help.

People that could find them were paying for them out-of-pocket beause their insurers had paid for Dilantin once already. They were not going to pay for the same drug again.

Meanwhile I was getting letters from the group I had come to know on the Epilepsy Foundation forum. Horror stories of treatment seeking gone wrong. Including an autopsy report. Idiopathic Seizure with a phenytoin level of 4.something. The range is 10-20. Broken bones, loss of teeth, loss of incomes, stitches, ER visits- all by people who had previously had good consistent control. A couple of those people were in different areas of medicine. One being a pharmachologist with epilepsy. How do you think we gained access to all of the information that we did?

And none of you would know about it even now if not for Ed taking the story and my attempt to allow you to know that things are not quite as they seem.

How many sNDAs has your drug gone through? Don't bother complaining about generics as long as you know they are generics, really. While it is sad that FDAs criteria for generic drugs is not tight enough- if branded drug makers can change their products without releasing that information- you're better off not getting too comfortable with safe and effective medications.

Dr. Helm you are correct. It is third party companies that collect patient demographics, not IMS.