Tuesday, July 22, 2008

Google Health: Personal Online Healthcare Accounts Are Here To Stay

Google has a new online feature called Google Health that allows you to enter your medical information in a personal account and track your medications, doctor visits, and prescriptions. Your account provides access to Google’s other tools such as links to relevant information matched to your health records to help you find out more information on the drugs you are taking, the medical conditions you have, and issues you should be aware of such as harmful drug interactions and side effects.

I am very encouraged by this new feature and commend Google for creating this service. I have felt for a long time that this is the natural progression of personalized health care towards an electronic network connecting the patient, health care provider, health insurer, and pharmacy becoming commonplace in the not too distant future.

Just as we seek better jobs now, patients will seek better doctors in the future.
We are living in a time when patients are just beginning to change the nature of their relationships with their doctors. I think this will mimic what has happened with the employee/employer relationship. Years ago, it was typical for an employee to join a company, spend their whole career with that one firm, and retire from the company with a pension. The employees of the past often looked to their employers to control their career and retirement plans. That relationship is dramatically disappearing. Pensions are now rare for new employees and have been replaced with 401(K) plans, placing the responsibility for retirement savings squarely on the shoulders of the employee. Coincident with this change of retirement responsibility, employees are in a “what have you done for me lately?” relationship with their employers when it comes to their careers. Employees are empowering themselves to control their career paths and many are in a perpetual state of job hunting. It is now common for employees to expect to work for several companies, possibly in several different fields, during their careers. I predict that similar changes will occur in the health care arena as patients take on responsibilities for their health care choices that have previously been left to their doctors.

Why, you may ask, shouldn’t patients simply let their doctors control their health care decisions much as past employees let their employers control their careers and retirement? The doctors are the trained experts, so why not treat them as surrogate parental figures and not question their advice. What’s wrong with that?

What’s wrong with that model is that it is not working for most people today as well as it once did. The close family physician who took care of a patient from birth to adulthood has been replaced with unfamiliar specialized practitioners. These specialists are experts in their specific slice of medical practice but only see you for a very short time in your life. Sometimes they only see you once and only for several minutes. It is not uncommon for the patient to be a stranger to the doctor. The ob/gyn doctor who supervised your birth is not the pediatrician treating your ear infection as an infant. The emergency room attendant fixing your broken bone is not the fertility specialist helping you start a family, the cardiologist helping your heart condition, the hematology/oncology specialist doing your blood work, the radiologist looking at your X-rays, the gastroenterologist helping your stomach aches, the podiatrist helping your foot aches, the dermatologist helping your skin rash, etc, etc, etc. As medicine has specialized, so have the doctors. Therefore, they may be more likely to treat your condition more than they are able to treat the whole you. To make matters worse, in order for doctors to make money with the current reimbursement practices, they need to see lots of patients each day. This means less time they have to spend with you.

On a single doctor visit, you may have three or more people talk with you. How often have you gone to the doctor and been shown to the room by one person and have a second person document your problem and medical history with a simple checklist. Then, after a brief consult with the medical assistant, the doctor comes in and quickly examines and tells you what you should do. The doctor briefly gives you some advice, prescribes some medicine, gives you best wishes, and leaves. End of visit.

So what did you do after your visit to the doctor?
Did you research your prescribed medications to see what similar medicines are also available on the market and how they compare to the ones you were prescribed?
Did you see if your medications have side effects or if they would have bad reactions with the other medications you’re taking?
Did you get a second opinion?

If you’re like most people, you probably left the choice of medication to your doctor and didn’t bother to ask another doctor for a second opinion. Hopefully, your doctor told you about possible side effects, but chances are that many of you didn’t specifically ask. When getting your prescription filled, you probably left it up to the pharmacist to determine if there are any concerns with bad reactions your prescription could have with other medications you’re taking. Again, you probably didn’t specifically tell them about your other medications and didn’t ask. Fortunately, many pharmacies are using electronic medical records to track your medications for you to find problems such as these (this will be the topic of another podcast). However, for something as serious as your own health, it would be great to at least double check your medicines… if you had that ability.

What did you do before your visit to the doctor?
Did you investigate your doctor before the visit to find out how well they rank compared to other physicians in your area?
Did you get reviews from other patients about the doctor, their staff, and the hospital or clinic they work for?

Again, the answers are likely “no”. You may have asked your family or friends to recommend a doctor, but you probably have no real idea of how good that doctor, medical staff, or hospital is.

Hopefully these problems will be solved in the future.
As you know, a major problem is that even if you wanted to do a lot of the above research, you couldn’t do it very easily. Fortunately things are starting to change. Sites like WebMD provide a lot of medical and drug information that you can read. However, for doctor, hospital, or even drug rankings, their isn’t much information available to you. It’s much easier to find thousands of movie or music reviews about just about anything you want to see or hear, but this type of rating and review system just isn’t available for most people when it comes to their health care.

Hopefully, this will all change in the future. I foresee that just as you can fill out your personal financial information for your online banking account that allows you to track your financial health, you will be able to fill out an online health account to let you track your physical health. Just as you can manage and track balance transfers, get email notifications of account activity, and apply for new bank accounts online, you will be able to track your doctor’s visits, pharmacy prescription status, and apply online for doctor’s appointments and prescription refills all from your one account. Even better, in the future you may be able to get email notifications of health problems immediately affecting you such as drug recalls, appointment cancellations, or prescriptions that are ready to pick up.

I see a future for social network ratings sites for doctors, hospitals, and drugs just as there are now for everything from restaurants, moving companies, hotels, and cars. Of course these should have some careful monitoring. Perhaps to ensure accurate rating information, some medical ranking sites can be tied to health care reimbursement companies and non-profit community resources that have a vested interest in knowing which doctors are successful in helping their patients and which are not.

So while some people may argue against personal medical record accounts because of security and personal disclosure fears, I think they should be welcomed with open arms. Just as you use your online bank account to help you strengthen your financial health, you should be able to use online medical accounts to help you strengthen your physical health and well-being. The access to information will be empowering for patients as they try to take charge of their own health care decisions.

Saturday, July 12, 2008

Generic Drugs: Discounted cost, Discounted ethics?

I have been frequently asked why generic drugs are cheaper than brand name drugs. Are they cheaper because they’re of “cheaper” quality or do not work as well? The answer is no (in theory at least). In spite of many people who will swear that generics don’t work as well as their brand name counterparts, generics are cheaper in cost because they required less financial investment for the company that makes them. How is that?

I want to address this question because it raises some interesting ethical issues that have come to light in the press recently and promise to continue…but I’ll get to those later. First, let’s look at why generics are cheaper in cost. To do that, we have to understand a little bit about how drugs are developed.

When a company wants to sell a drug in the US, they need the approval of the Food and Drug Administration (FDA). The company must file an application to the FDA that proves that the drug is 1) safe, and 2) effective. This is referred to as the drug’s Safety and Efficacy profile. In order to get the data to prove this, the company had to go through 6 major hurdles:

1) Identify a chemical or molecule with the desired effect. This involves a lot of screening through candidates to find the one or several that look promising. This is the research phase of R&D.

2) Show that the chemical or molecule (I’m just going to call it a drug from now on) can be manufactured in large enough amounts to not only test it in drug trials, but also be able to sell it. This is often referred to as the commercialization phase of the development portion of R&D.

3) Show that the drug is likely to be safe in humans. This involves testing it in animals. It must be shown to be safe in an animal (usually several species of animal) before it can be allowed to be given to a human. This and the next step belong to the Non-clinical phase of drug development.

4) Show that the drug is likely to be efficacious (i.e., beneficial) in humans. Again, this involves animal testing.

5) Show that the drug IS safe in humans. This is the Clinical phase of the drug testing. This starts by giving the drug to healthy people and measuring the results to make sure no damage is done.

6) Show that the drug IS efficacious in humans. This is when the drug is given to patients who have whatever the condition is the drug is trying to help. This can involve testing the drug in thousands of people to make sure enough data is gathered to know if the drug works.

If all of these steps are successful, the company can put all the data together and send it to the FDA to prove that the drug should be approved for sale. Going through the 6 steps above can often take 15 to 20 years to complete and cost greater than $1 billion (yes, that’s with a “b”) dollars. That’s a lot of time and money. To make it worse for the company involved, over 80% of drug candidates fail to make it all the way through all 6 steps and get approved. So in short, it costs lots of money to look for and develop new drugs.

So when a drug does make it all the way through, the company sells it at a high price to recoup their investment costs and make a profit to keep the company going and fund future research to find the next new drug. The company can be helped in keeping it’s price high if they can get a patent on their new drug. If their drug is awarded a patent, the company is given exclusivity for selling it, usually for 17 years from the time the patent is granted. This means no one else is allowed to sell that drug until the patent expires. (Hint: this leads to the first ethical dilemma that I’ll get to in a moment).

So why are generic drugs a lot cheaper? They are a lot cheaper, because when a company applies to the FDA for approval to sell the drug, a lot of the hurdles that the FDA puts in place have already been cleared by the company that made the original brand name drug. In fact, even the name of the application sounds easier. The brand name drug maker had to file what’s known as a New Drug Application (NDA) to the FDA to get approval. The generic drug maker files what’s known as an Abbreviated New Drug Application (ANDA). As you can guess, the “abbreviated” NDA is quite simpler. The generic drug maker doesn’t have to start from scratch and toil through laboratory, animal, and human screens to find a winner. The winning drug candidate has already been chosen for them. They don’t have to redo all the lab testing that the original company did. Instead, they just have to prove that their generic drug is identical to the brand name drug. This is known as bioequivalence, namely that the generic drug has the same chemistry and biology that the brand name drug has with identical effects on the human body.

In other words, the generic drug is physically and behaviorally identical to the brand name. (Hint: this leads to the second ethical dilemma that I’ll address). This is still quite a lot of work to prove bioequivalence, but nowhere near what the research and development costs of the original brand name were. So because it was a lot cheaper to develop, the company can charge less for it. Also, because they had to prove bioequivalence, the generic drug is (hopefully) just as good as the brand name.

OK, so what are the ethical dilemmas I’m interested in that have resulted from this scenario?

The first involves the issue of granting patent exclusivity to a company that makes a new drug or method of using the drug. This legal protection is a huge incentive for a drug company. Knowing that they will have this exclusivity is what allows them to take the huge risks of research and development to find new drugs. Without this protection, a company could spend billions of dollars in developing a drug and as soon as it gets approved, another company could start selling the same drug at no prior development cost of their own. If you were the original company, you’d probably think twice before developing another new drug any time soon.

So patent protection is a very good thing to motivate companies to invest in the future and create new drugs and medicines. However, as you may have been hearing about in the news recently (OK, probably not if you’re watching CNN or your local evening news), generic drug companies in countries with large amounts of people living in poverty want to ignore these patents. They’re claim is that getting cheaper drugs now to poor people who otherwise cannot afford them outweighs the legal issue of patent infringement and they should not have to wait until the patents expire. This issue has come up several times in the recent past in several Asian countries such as India and Thailand. So is this a bad thing?

I wholeheartedly believe in getting drugs to the people who need them, especially the poor, but I have several problems with this. First, ignoring patents can greatly damage the business incentive to develop new and better drugs. Second, allowing companies to create generic drugs in violation of patent law is likely leading down a path where legal regulations can be too easily dismissed. This can lead to the dangerous situation in which the drugs are being massed produced with the focus on low cost rather than quality manufacturing with regulatory and legal oversight. Even if the “ethical” generic drug manufacturer who ignores the patent protection for the sake of the poor maintains good quality, they have opened the door for counterfeit manufacturers to get into the action. This may too easily lead to less potent, or worse, tainted or contaminated generic drugs.

If you think this problem would be restricted to the poor countries, think again. I would guarantee that as soon as cheap generic drugs became available in poor countries while only the brand name drugs (because of patent protection) are available in the wealthier countries, a black market distribution would be set up almost overnight by some unscrupulous distributors.
So my worry is that while the idea of breaking the legal patent rules for the sake of the poor may be idealistic, breaking patent laws under the guise of a Robin Hood hero may do a lot more than rob from the rich and give to the poor. It could very well lead to hurting both drug companies and patients. In fact, they could be giving a double negative whammy to patients. In the short term, patients may suffer from “cheap” generic drugs of poor quality that could jeopardize their health. In the long term, patients may suffer from the lack of new, better drugs because companies weren’t willing to take the investment risk.

But before you decide that I’m totally in defense of the brand name drug companies, let me now talk about the second ethical dilemma. Let’s assume now that a generic drug company respects the patent laws and waits it out for a patent to expire on a brand name drug. Now that the patent has expired, the company can get approval to sell the generic drug. Remember, to do so, it must prove to the FDA their generic drug is bioequivalent to the brand name drug. Well now is when the maker of the brand name drug can start playing some “is it ethical” games.

One game they can play is to strike a deal with the generic drug maker. Basically, they can make a deal that the generic drug maker will not make a generic drug to compete with their brand name drug in return for whatever favors can be negotiated. This may be cash payments or partnerships on other drugs.

Is that unethical?…probably not, but it’s not exactly great from a patient standpoint. However, there is another thing the brand name company can do that is even more controversial (I think). The brand name company can file a patent infringement lawsuit against the generic drug maker. A government statute known as the Hatch-Waxman Act stipulates that such a lawsuit delays any FDA approval of the generic drug for 30 months or until a court rules in favor of the generic drug maker (unlikely to happen quickly). This gives the brand name drug company extra time to sell their drug at full price. For brand name drugs, some bringing in greater than $1 billion dollars a year in revenue if it’s a real blockbuster, this can be some serious cash!

The Hatch-Waxman Act is definitely not bad or itself unethical. In fact, it has been a terrific law for getting generic drugs approved while providing a nice protection to make sure patents are not infringed upon. But what the brand name drug company does during those 30 months could get a little sketchy. A brand name company may use those 30 months to change the nature of their approved drug. Maybe change the dosing, change a tablet to a capsule, etc. Now what happens? The brand name drug company can try to get their patent extended if their new formulation or drug activity can be shown to be superior to the original version.

Now don’t get me wrong. If the new version is truly better, than the patent extension is deserved. What’s not so clear cut is when the change is slightly (or arguably not) better. Does an incremental increase deserve patent protection and therefore protected high drug costs versus the benefit a patient population may get from having lower costing generic versions? Or think about this one… remember the concept of bioequivalence? The generic drug maker had to show their drug was identical to the brand name drug. However, they may have just had the target moved on them while they were in legal limbo. The brand name drug is now in a new format, different from what they were trying to compare with and be identical to. The brand name drug maker may try to claim that their new improved drug is no longer bioequivalent to the generic drug trying to get approval.

Improving a drug is a wonderful endeavor and should be pursued. What is less wonderful is if the brand name drug company improves it’s drug but waits to apply for approval of the improved version and subsequently the patent extension only at the last moment of patent life, trying to maximize the full amount of total patent protection. That may be good business and profit protection, but it can be terrible for the financial burdens on patients and health care payors.

So you can see the ethical issues I raise center on the same general issue: At what point is the financial burden on the patient more important than the patent protection of the high cost drug? Unfortunately, like most major problems facing the world today, the answer is neither simple nor clear.

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