Tuesday, September 9, 2008

What are all those drug ads saying?

Why are all those smiling people talking about bad drug side effects on TV?
We are now all familiar with seeing drug ads on TV that talk about all the benefits and risks of prescription drugs. These commercials have become the common butt of many jokes to see a bright smiling attractive-looking face talking so openly about the diseases and medical problems they're suffering from and the medications they're taking. The commercial actors speak so comfortably about the various potential side effects the drug may cause such as nausea, vomiting, muscle aches, burning sensations, etc., etc. Each prescription drug commercial is almost formulaic: 1) Smile at camera, 2) mention what illness you have, 3) talk about how this drug has helped you, 4) tell people about a list of potential side effects, and 5) tell people to ask their doctor about more information.

The reason these commercials are so formulaic-looking is because they are. There is actually a set of rules that tell drug advertisers what they can (and can't) say in prescription drug advertisements. So who makes these rules and what are they? That is the topic of this blog.

Who makes the rules?
There are 2 types of drug classifications based on how you are able to obtain the drug. Prescription Only drugs (which I'll simply refer to as prescription drugs) can only be obtained by prescription from your health care professional (makes sense given the name). This is in contrast to Over-the Counter drugs that can be purchased at pharmacies or other stores without a prescription. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and sale of both classes of drugs in the US. However, the FDA only regulates prescription drug ads. Advertisements for Over-the-Counter drugs are regulated by the Federal Trade Commission (FTC). Our focus is on prescription drug ad rules and regulations, therefore we will focus on the FDA.

The FDA's main goal regarding prescription drug ad regulations is to ensure that drug companies provide information in their advertisements that is truthful, accurate, and balanced regarding the positive and negative drug effects. Remarkably, the FDA typically does not require prescription drug ads to be reviewed and approved prior to their public use. Rather, the FDA often reviews these ads after they have already started being used. There is an FDA division called the Division of Drug Marketing, Advertising, and Communications (DDMAC) that monitors these prescription drug advertisements. This job was a lot easier prior to the mid-1980s when the drug advertisement landscape drastically changed.

How do drug companies advertise their drugs?
Prior to the mid-1980s, drug companies advertised prescription drugs only to health care professionals (HCPs), such as doctors and pharmacists. The HCPs then relayed that information to their patients to whom the drugs were being prescribed. However, during the 1980s, some drug companies started to advertise directly to the public, an approach refered to as Direct-to-Consumer (DTC) advertising. DTC ads changed everything. They were and continue to be highly controversial. Because of the controversy, many drug companies abide to a moratorium on DTC advertisements for six months after a new drug comes to market. The US Congress is currently asking drug companies to agree to a two year moratorium on DTC ads, but no companies have taken them up on the offer.

With the advent of DTC ads, drug companies now have multiple ways of marketing their drugs. A few things they need to consider are:

Who is the target audience of the ad?
Drug companies now have 2 different audience groups to consider: 1) the HCP (e.g., the doctor), and 2) the patient (i.e., the consumer). There are different FDA rules based on which of these audiences is being targeted.

When will the ads be used?
The drug company can choose to advertise the drug before the actual FDA approval to sell the drug. These ads are known as pre-approval ads. Drug ads that are used after the actual FDA approval to sell the drug are known as post-approval ads. There are different FDA rules for pre-approval ads versus post-approval ads.

Where will the ads be used?
Drug companies can advertise in many locations. Pamphlets and brochures can be placed in the doctor's office. This type of media distribution is part of what's called promotional labeling which is often treated differently from advertisements. Drug advertisements tend to be either in print (e.g., magazines, newspapers) or broadcast media (e.g. TV, radio). There are different FDA rules for print ads versus broadcast ads.

Will the ad mention the drug's name?
This may seem like a strange question? Why wouldn't the ad mention the drug's name? Well, for reasons we'll address in a moment, the drug company may not want or, as we'll see, may not be allowed to mention the drug's name. An advertisement that does mention the drug's name is called a branded ad. An advertisement that does not mention the drug's name is called an unbranded ad. (As a side note, pre-approval drug ad campaigns cannot use both branded and unbranded ads, so marketing departments must carefully plan their promotions.)

Product Claim Ads
A familiar type of branded ad is the Product Claim Ad. Product Claim Ads not only name the drug but also discuss its benefits and risks. This is the type of ad that probably comes to mind when you think of a TV drug ad. The FDA requires that Product Claim Ads not be false or misleading and must be understandable by the average person
Product Claim Ads, whether they appear in print or on TV, must include the following key components:
1) The drug's name. This must include both the brand name (i.e., the drug company's proprietary name) and the generic name (the non-proprietary name).
2) The drug's FDA-approved use
3) The drug's most significant side effect risks. These risks must be stated in a balanced manner relative to the drug's benefits.
4) a statement that the drug is obtained by prescription only (remember, we are dealing with prescription drugs. Over-the-counter drugs are regulated by the FTC).

Drug companies are prohibited from advertising any drug benefits that have not been approved by the FDA for that drug. Interestingly, doctor's are allowed to prescribe a drug for uses other than the FDA-approved use. This Off-Label prescribing is a highly controversial issue, but will await a future blog.

In Product Claim Ads, drug companies must provide the consumer access to lots of details about the FDA-approved usage of a drug. These FDA-approved drug details are contained in the drug's Prescribing Information. This information can be found as a document in the drug's container known in the US as the Package Insert (PI).

The prescribing information includes lots of details about the drug including:
1) the drug's chemical description
2) the FDA-approved drug use (i.e., what medical condition does the drug help)
3) the drug's method of action (i.e., how it is believed to work)
4) the drug's interactions with other drugs, health supplements, or foods
5) who should not use the drug (e.g., children, pregnant women)
6) the drug's side effects, both serious and non-serious risks even if they may be rare. Risks that may lead to death or serious injury may have the warning information displayed within a black-bordered box. Such a warning is referred to as a Boxed Warning or a Black Box Warning.

So how does the drug company put all of this information into its ad (and still get you to be interested in buying the drug)?
The FDA ad rules for Product Claim ads are slightly different depending on whether the ad is printed or broadcasted

Print ads must include a Brief Summary of all the prescribing information listed above. The Brief Summary is usually on a separate, but adjoining page to a nice colorful ad page with lots of pretty graphics to catch your eye. Check this out next time you see a Product Claim ad in a magazine and you'll find this Brief Summary page next to every main drug ad page (if you don't, you can report it to the FDA because it would otherwise be illegal). The Product Claim ad will often also provide sources of further drug information, such as a website and toll-free telephone number. In addition to the Brief Summary, the FDA requires that all print media Product Claim ads include the exact statement "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." (again, look for this next time you see a Product Claim ad in a magazine...go ahead, it will be fun.)

Broadcast Product Claim ads must meet what the FDA calls Adequate Provision when providing drug information. Broadcast Product Claim ads do not have to state as much drug information as print ads do. This makes sense because it would be costly, time consuming, and not very welcoming if the broadcast ad had to tell you all the Brief Summary details. Believe me, you would turn the TV channel before the actor even got close to being done.

Instead of a Brief Summary, broadcast ads just have to provide what's known as the Major Statement. The Major Statement presents just the most important risks that the drug presents. The Major Statement may be provided as text in the TV video, but it must be spoken. So this is why that smiling actor on TV is telling you about the drug's main side effects. They are giving you the requisite Major Statement of the drug. This Major Statement helps the drug company fulfill the FDA's Adequate Provision requirement, but it is not sufficient. In addition to the Major Statement, the drug company must provide ways that the listener (radio) or viewer (TV) can find the drug's FDA-approved prescribing information. This may include a toll-free phone number, a website, a magazine containing the print version of the ad, or a recommendation to ask your doctor. So now you know why the actor keeps recommending you speak to your doctor ... they are fulfilling the Adequate Provision requirement.

So that's a lot of information that drug companies need to know about advertising their drug. But that just covers Product Claim ads. There is another type of Branded Ad that doesn't need so much detailed information. This is known as the Reminder Ad.

Reminder Ads
Reminder ads give the name, but not the use, of the drug. Remember, the Product Claim ad claimed how the drug is to be used. So why in the world would a drug company spend the money on an ad that doesn't even tell people what to use it for?

The Reminder Ad is used when the drug company assumes that the consumer already knows what the drug is for and simply needs to be reminded of the drug's name. Reminder Ads do not contain any drug risk information since they do not discuss the use for the drug. In fact, Reminder Ads cannot suggest in any way (graphically or in words) what the drug's use is. If they do, they become Product Claim ads and must follow the rules outlined above.

Like Product Claim ads, Reminder Ads must include both the brand name and the generic name of the drug. Reminder ads cannot be used for drugs with a Black Box Warning.

Coming Soon Ads
While Reminder Ads are released post-approval to remind a consumer about a drug, Coming Soon Ads are used pre-approval to let healthcare providers know that a drug is coming to market (assuming it gets FDA approval). Coming Soon Ads, like Reminder Ads, do not contain any drug use information, but may contain the drug's name, logo, and company. They are used to start getting doctors and pharmacists familiar with a drug's name, even if they don't know yet how it will be prescribed. Since the drug has not yet been FDA-approved, Coming Soon ads are limited to healthcare providers as a target audience and cannot be targeted to consumers.

Help-seeking Ad
As mentioned before, some ads are unbranded ads, namely they do not mention the drug's name. You can imagine that if you don't even mention the drug's name, you don't have to provide the drug's prescribing information or risks. One such unbranded ad is known as the Help-seeking Ad. A Help-Seeking Ad describes a disease or medical condition but does not recommend or identify any specific drug to help the condition. Help-seeking Ads can include the drug company's name and provide a telephone number or website to contact for more information. The FDA does not regulate these ads (as long as they obey the simple rules mentioned). Instead, they are regulated by the FTC.

And Now You Know:
So now you know some basics of drug advertisements and how they are regulated. You now can be on the lookout for ad components such as the Brief Summary and FDA contact wording in print Product Claim ads. You can listen for the Major Statement, "ask your doctor", and other Adequate Provision components the next time you see a Product Claim ad on TV.

I hope this blog has given you a little insight into the wizard behind the curtain. So next time you see a drug ad, look or listen a little longer than you did before and revel in the joys of knowing a bit more about why all those smiling actors are so happy to share their medical risks with you.

Saturday, September 6, 2008

Your Pharmacy May Soon Be Releasing Your Medical Information

There is currently a bill in the California state government that would allow your pharmacy to send your prescription drug information to advertisers and pharmaceutical companies.

The bill would limit the information that can be sent to only the prescribed drug information for the purpose of providing healthcare services to the patient. The pharmacy is required to disclose any financial rewards it receives for sending out your medical information.

The advantage that this bill may have is that it could help with patient compliance. Patient non-compliance, meaning patients who do not follow their doctor's instructions on taking their medications, is a huge problem. Patients may forget to take their medications or often they simply stop taking their medications once they start feeling better. They may not refill their prescriptions if they feel the cost of the drug outweighs their current suffering.

Patient non-compliance is a large public health problem because prematurely stopping their medication can lead to the loss of control of their medical condition. This can have severe consequences if they are being treated for life-threatening situations such as infections, heart conditions, or high blood pressure. In addition to the medical risk that non-compliance has, the drug companies want to stop non-compliance because it costs them many millions of dollars each year due to drugs that are prescribed but not completely purchased by the patient.

So this new bill is being touted as a win-win for patients and drug companies. When the drug company is notified by the pharmacy that you have been prescribed their medication, the drug company may start sending you information about how to take the drug and give you prompts and reminders when you need to retake or refill the drug. This way, the patient takes all their medication which helps their health and the wallets of the drug companies.

The cons of this bill are that your personal information is being shared to a third party, in this case the drug advertisers. You may not want or welcome the advertisements and the reminders coming to you from the drug company. Besides the possible unwanted drug advertisements being sent to you, there is always the issue that your personal health information has been distributed without your direct control. While there will be some safeguards to keep your records secure, there is never 100% security and once your information has been sent out, it may be hard to track and monitor. The bill says that patients will have the option to opt out of the program and not let their pharmacy send their prescription information to other companies.

My conclusion:
The transfer of electronic medical records between health care providers, pharmacies, and third party companies is here to stay and will become more and more commonplace. This bill is simply one of many to come that will try to regulate this issue. Electronic medical record transfers promise to have great rewards for patients health safety, but clearly have a lot of risks for keeping patients' personal information secure. People will need to become much more involved in monitoring their personal health information in much the same way they now need to monitor their personal finance information. Just as you need to be smart about how you provide your financial information to strangers, be smart about how you provide your medical information to strangers, as well.

Friday, September 5, 2008

Important Legal Changes that Asthma and COPD Patients Need to Know

If you use an inhaler to treat your asthma, emphysema, or bronchitis, make sure you talk to your doctor about the recent legal changes in inhalers.

On May 30, 2008, the Food and Drug Administration (FDA) notified the medical community to change the types of inhalers used to treat asthma. This change is being done to end the use of chlorfluorocarbons (CFCs) as a propellent. CFCs have been used in products like hairspray and asthma inhalers to propel out the product chemicals. In the case of asthma inhalers, the propelled product is usually the drugs albuterol or levalbuterol. However, CFCs have long been known to deplete our planet's ozone layer and contribute to environmental hazards.

As of January 1, 2009, CFC-containing asthma inhalers will be illegal for sale, manufacture or distribution in the US. In place of CFCs, inhalers will use hydrofluoroalkane (HFA). Inhaler manufacturers are working to ensure that HFA-containing inhalers will be available to fill the demand.

You should talk to your doctor now to start using an HFA-containing inhaler instead of a CFC-containing inhaler. This will get you familiar with using and caring for the inhaler. You may find that the HFA-containing inhaler has a different look, feel, and taste than the CFC-containing one you are used to. However, the HFA is just as medically safe and effective as the CFC was in providing the needed medication, without the environmental cost.

I recommend not waiting until the end of the year to switch. Better to change now and have a longer time to get used to the new HFA-containing inhaler. Next year, it will be your only option in the US.

Monday, August 11, 2008

Who owns your medical history?

You may think that you own your medical history, but you may be mistaken. New trends in the medical field are changing the way patients medical records are stored and used. This promises to help millions of people each year and improve patient safety, but make sure you know who really owns your health history.

Hospitals and medical care providers are moving away from paper documents to keep patients records and are moving towards electronic records. Electronic medical records (EMRs), also known as electronic health records (EHRs), will allow for faster and more efficient transfers of patient data from the doctor to the pharmacy and to the health insurance company.

This move from paper to electronic has obvious advantages for the hospitals. The storage and retrieval of patient information is much cheaper and faster. The move will help many patients, too. In particular, the electronic transfer of prescriptions from the doctor’s office to the pharmacy promises to dramatically reduce the number of prescribing errors that occur due to misread doctors’ instructions.

We all know and have seen the chicken scratch abbreviated instructions that doctors often write on paper prescriptions. Errors in prescribing and taking medications pose a very serious problem. A 2006 report by the Institute of Medicine estimated that 1.5 million people are injured each year by medical errors including deaths. The cost of these errors is in the billions of dollars each year. Having electronic medical records will help alleviate the problems of misreading hand-written prescriptions. In addition, patient safety can be increased further if the electronic prescribing system can be linked to drug safety databases and personal medical records that could automatically check for a drug’s side effects and potential problems with a patient’s known allergies or other medications they may be taking. All these benefits have created a strong impetus to increase the use of electronic medical record systems. In fact, President Bush stated that he wanted every American to have an electronic medical record by the year 2014.

Electronic medical records are a wonderful advance for handling patients’ medical records, but do have some concerns. One problem is that they are only as good as the person entering in the information, so having a quality control system in place is important. Another large concern is the issue of confidentiality. Knowing who is looking at these electronic medical records can be problematic for patients.

Health and life insurance companies are starting to use these records to access the medical risks that an applicant poses. This in itself makes a lot of business sense, but other companies are in the business of selling medical records. Patient medical information is being packaged and sold to third party companies, such as insurance companies and other interested parties. In fact, if you aren’t careful, your medical information could be sold without your knowledge.

There are government rules for how electronic medical records can be used. The Health Insurance Portability and Accountability Act (HIPAA, pronounced “hip-ah”) sets rules and standards for how electronic medical records can be shared. It contains a Privacy Rule that instructs companies holding your electronic medical records to inform a customer about their policies for sharing electronic medical records. When you sign up for insurance or a health care plan, you should be presented with the company’s policies for sharing information. You may choose not to accept their policy, but your failure to consent could prevent you from getting approved. When signing these forms, pay attention to what their policies are.

For companies that sell medical records, the HIPAA rules require that they protect a patient’s identity. If you feel that your information has been misused, HIPAA protects your right to receive a report on who your information was shared with. If you think it has been improperly shared, you can file a complaint with your provider or insurer, or with the US government if you feel that your concerns are not being addressed.

The move to electronic medical records will save many lives and improve healthcare, but consumers need to pay attention to how their health information is shared, just as they would their financial information.

Saturday, August 9, 2008

Public Transportation and Organ Transplantation: How are these related?

One of my favorite podcasts is EconTalk (http://www.econtalk.org/), a fantastic listen for anyone interested in how our daily lives are affected by economics and reward incentives. Each episode is about an hour long and covers a wide range of topics. I love the show and have wanted to spread the word about it, but most of the economics topics haven’t fit with my podcast’s focus on the medical field and pharmaceutical industry. However, a recent episode entitled
Munger on the Political Economy of Public Transportation had a very interesting segment that I’d like to speak about. Now, I know the episode title says “public transportation”, and this in itself was a very interesting discussion, but the part of the episode that really grabbed my attention was about organ donation and transplantation. (That’s quite a teaser, huh? You’ll have to listen to the podcast to see how in the world a discussion on public transportation in Chile could lead to the topic of organ donation).

I understand that the topic of organ donation may be uncomfortable for a lot of people. Because the types of tissues and organs that a person can donate while they are alive is limited (e.g., a kidney), the issue of organ donation usually deals with the unfortunate death of a person, in this case it's you, the donor. That's not to mention that some people are simply squeamish when it comes to thinking about surgical procedures and internal body parts. However, the topic is too important to put aside simply because it makes us uncomfortable to acknowledge our mortality. So with that, I hope you'll consider the topic for discussion.

The idea being discussed on the EconTalk podcast I mention above centered on the question of why not have organ donation be privatized and the organ donor’s family be financially rewarded for the organ donation of their lost loved one. I found the idea very intriguing and wanted to comment on it. Currently, organ donation continually suffers from high demand for organs but limited supply. There simply are not enough people donating their organs and tissues to help all the patients who need them. If you need an organ today, you are put on a waiting list and must hope that an organ will become available for you from another person ,who unfortunately is likely now deceased but was very kind enough to voluntarily consent to donate. If you are on the waiting list, you may be ranked according to your need and your probability that a new organ will help you. Younger people may be seen to benefit more than older people based on expected remaining life spans. More gravely ill people may get higher priority than less ill people, because the less ill people likely have more time to wait for another organ to become available. Someone who needs a transplant but is otherwise healthy may get higher priority than someone who needs the same transplant but also has other medical problems that can limit their survival.

Many people in need of transplants will likely die while on the waiting list. OrganDonor.Gov is a US government agency website providing Organ and Tissue donation and transplantation information. As their website shows, the problem is quite significant:

Organ/Tissue Transplant waiting list candidates (as of 7/28/2008): 99,363
Transplants performed January – April 2008 (as of 7/25/2008): 9,029
Donors January – April 2008 (as of 7/25/2008): 4,578

In the US, there is a federal law (the National Organ Transplant Act) that places limitations on organ and tissue donation. However, the practice is primarily state regulated. By the rules, an organ donor must agree to be an organ donor while they are alive. This consent is often displayed on the person’s driver’s license. However, the current scarcity of organs and tissues for donation suggest that this dependency on volunteerism solely for humanitarian reasons is not sufficient. In fact, even if you volunteer to donate, your family may overrule your donation consent if your wishes were not clearly communicated. So is there a better way to get people to donate?

Surely, we should continue and even increase public service announcements and appeals for people to be aware of the problem and be willing to donate their organs. However, organ donation is likely never to be high on the list of things a healthy person wants to think about while they go about their daily living.. Also, with organ donation being a charitable gift, there are not many financial resources available to mount a large media campaign. The government does what it can to get the word out and I commend the government for using public services like the Department of Motor Vehicles offices to raise awareness of the issue when people obtain or renew their driver's licenses. Like any charitable gift situation, when the topic of the need for organ donation is presented, many people understand the reason for giving and care about the problem trying to be solved. However, there is typically no call to action to motivate a healthy person to consent to a donation.

So how can we increase the supply of organs and tissues for the patients who need them?
Stem cell research is being touted as a way to help alleviate the scarce supply. Stem cells are cells that have not fully developed (differentiated) into the types of cells most people are familiar with (e.g., skin, muscle, nerve) but have the potential to do so under the right conditions. We all have stem cells in our body. The hope is that scientists can learn how to create these right conditions to be able to control stem cell development. In an ideal situation, stem cells could be 1) obtained from a patient in need of an organ or tissue, 2) developed in a laboratory to form the organ/tissue needed, and 3) given back to the patient to fix the problem they are suffering from. As we all know, stem cell research is currently a highly controversial political and social issue that is putting limits on the research. However, even if the public and government were to fully agree to use stem cells, the problem of organ/tissue scarcity will not quickly go away. Scientists are working hard to understand how to control the development of stem cells into cell types that can be of medical value (e.g. muscle, neural, skin), but the ability to create complex organs like a kidney or heart in a laboratory is not going to happen any time soon.

What about using animal organs and tissues?
Animal organs are a potential source and have been used for some transplantations (usually from pigs). This transplantation, from animal to human, is called xenotransplantation. Again though, this has all kinds of problems. Like stem cell research, xenotranplantations have all types of moral and ethical dilemmas and does not sit well with many animal rights activists. Also, the medical risks and limitations of xenotransplantation are significant. Many animal organs are not physically compatible with humans and transplant rejection would be, and is, a serious concern. Also, the types of organs and tissues that could be used from an animal are limited.

So can we improve the human donation situation we have now by financially rewarding people for donating?
The idea of paying for organs likely raises a lot of eyebrows. Financial incentives and the desperation of dying patients needing transplants have already created a black market for organs in some countries. Patients may travel to a country and pay for an organ to be donated. These "transplant tourists" must be wealthy enough to pay for the service and therefore limits the service to the relatively rich. In contrast, the countries and donors that supply the organs are often relatively poor. This financial inequity may not only be distasteful because of exploitation of the poor, but can have tremendous health risks when the transplantation is done in places without adequate modern medical and safety equipment and training.

But what if we were to legalize and regulate the financial trade of organ donation? What if rather than asking people to volunteer to donate, you gave them a monetary incentive to do so?
Without a doubt, people would be much more motivated to donate. In fact, organ donation consent could be included as part of their insurance, will, and other estate planning. A person could sign a contract with a private company, such as their insurance agency, that upon their death, if their organs are healthy, they could be donated to needy patients in return for monetary compensation paid to their designated benefactor. This legal contract would help alleviate the financial burden on the deceased's family and loved ones while providing a life-saving resource to others in need.

Such a financial incentive system for legalized organ trade would have to be carefully considered before implementing to ensure adequate safeguards for all parties involved.
- There would need to be safeguards to ensure that the donor does not become seen as a commodity to the corporation. The monetary value of the donor's organs and tissues should not be considered to outweigh any efforts to save their life in a time of crisis.
- Safeguards against donor fraud would need to be created to make sure that a donor and the donor's family do not fail to disclose medical problems that the donor has for fear that their compensation would be jeopardized. This is one reason that I think the donor's insurance agency may be the most appropriate holder of the contract since they are in the best situation to monitor and evaluate the donor's medical history and status at the time of death.

So as you can see, I think this is a very interesting and important issue filled with ethical, moral, medical, and financial issues for debate. I find the idea very interesting and would love to hear any comments you may have. Also, I encourage you to listen to this and other great topics discussed on EconTalk. I have no ties with it other than simply being a big fan of the show. I thank them once again for another thought provoking topic, especially one so close to my main interests.

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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