My GRIP Experience

Thanks, Brie...

2007-09-21T16:54:00.000-04:00

Sex and Drugs: The Era of Fashionable Pharmaceuticals

2007-08-18T22:22:00.000-04:00

Brands are an image. You see them everywhere: designer jeans, luxury cars - even coffee is trendy. Indeed, we live in a material world. And often times, we make purchases not based on judgment, logic or experience, but rather, on brand alone.

Marketing has revolutionized the way our society functions. Huge corporations have been founded on the lone principle that we are an impressionable people (thank you for hosting this blog, Google). Today we absorb more information than ever before, consciously or not, and capitalism is rightly taking advantage of it. And it certainly is not uncommon for this information to appeal to our desires and emotions, for this is the tried and true method of establishing brand loyalty. This is how fashion is created.

But since when have prescription drugs become commodities of haut monde?

In the past decade, pharmaceutical companies have nearly tripled their spending on promoting their products. What is troubling, however, is that the majority of this marketing explosion can be attributed to the growth of direct-to-consumer (DTC) advertising. These DTC advertisements are marketing campaigns directed at the general public, and are the reason so many prescription drug brands have become household names. And these advertisements have gradually taken on the form of traditional, consumer product marketing. They appeal to us through feelings of hope, happiness and fear. They even tempt our sexual desires.

DTC advertising has effectively positioned brands like Zoloft, Lunesta and YAZ among the ranks of Budweiser, Calvin Klein and Lexus.

Questions must be asked. Does this type of marketing affect physicians' prescribing habits? Do "consumers" have the ability to look beyond emotional innuendo, and can they adequately comprehend all risk associated with using a certain drug? Should the public even know drugs by name?

After all, aren't physicians specifically trained to be solely responsible for their patients' health? Patients know what ails them, and doctors treat - that's how health care works. But DTC advertising has effected a reversal of roles. Patients now visit their physicians pre-armed with an advertisement-inspired treatment plan. When patients request prescription drugs by name, they effectively pressure their doctors into making decisions that may not be in their best interest.

And even more disagreeable is that DTC advertising is often misleading. FDA reprimands against pharmaceutical companies for violating DTC regulations have grown as markedly as the advertising campaigns themselves. DTC advertisements frequently exaggerate effectiveness and/or minimize side effects. And yet, the FDA has done little to curtail these deceptions. And as the FDA grows shorter on funding and more susceptible to pressure from the drug industry, we can only expect this situation to escalate.

Meanwhile, physicians and patients alike need to maintain vigilance. Our society needs to understand that DTC advertising is not an educational tool - it is simply a tactic used by the pharmaceutical industry to boost sales. Accordingly, we must learn to simply ignore it. The best way to end DTC advertisements is to end their persuasive power.

Mike Sharley, Esquire

2007-08-18T04:02:00.000-04:00

Well, it's late (or early, depending...) and I'm up browsing health care blogs. I came across a YouTube video for the CNN debate and thought it was pretty clever. And now that I'm becoming more accustomed with the "blogosphere," I have "embedded" it below:

Karen Ignagni: President, CEO, Spin Doctor, Heartless Devil

2007-08-14T15:09:00.000-04:00

She's in charge of the largest lobbying organization representing the health insurance industry. She's the reason there are 50 million people without insurance in this country. She's why insurance companies can get away with unethical practices. She's got the ear and pocket of just about every legislator in D.C.

And you most likely pay her $1.2 million paycheck.

Firstly, let me exonerate myself of any bias. I do not advocate for government-run, single-payer, or any radically interpretable style of universal health care. Nor am I a proponent of a market-based system. I prefer to take the safe, albeit somewhat cowardly, stance of supporting universal access to and quality of health care by whatever means necessary.

But Karen Ignagni does not share this ideal. Her motivation is money. She has not only sold her soul to the Devil, she is now playing his personal collection agent. And that's what makes her so good at what she does.

Karen Ignagni is the President and CEO of America's Health Insurance Plans (AHIP). This organization represents companies providing health insurance coverage for more than 200 million Americans. AHIP advocates for issues like increasing Medicare Advantage (MA) spending and reducing intra-industry competition by supporting huge corporate mergers. To do this, Ms. Ignagni maintains quite a boisterous presence on the Hill, and an even louder voice.

Ms. Ignagni has the unparalleled skill to twist any issue to her and her organization's members' benefit. Of course this is the tried-and-true method of politics, but she is the Barry Bonds of the political arena. She can sit in a room full of skeptics and critics and transform them into believers within an hour. While not much good can potentially arise from the issues she fights for, Karen Ignagni still manages to gain support.

For instance, in Dayton alone, 89% of the market is shared by WellPoint and United Healthcare. This restricts coverage options available to patients and practice options for doctors (physicians are not legally able to unionize). This oligopoly is representative of nearly every geographic market in the United States. And yet, few legislative and judicial means have been utilized to limit insurance companies' stronghold on the market share.

As for MA, I witnessed Ms. Ignagni explain to a roomful of health reform advocates that MA cuts would be disastrous to senior care. Keeping previous posts on the issue in mind, as well as the American Association for Retired Persons' (AARP) stance that such cuts would benefit seniors, MA plans are merely money-making programs for the insurance industry and do not provide beneficial care options. And yet, Karen Ignagni managed to walk out of the conference as a champion for senior's health.

If you are ever faced with Karen Ignagni's rhetoric, I have some simple advice: Distrust her words, distrust her savvy, and distrust her motives.

Watch Karen Ignagni in action as she responds to Michael Moore's SiCKO:

Medicare Shareholder Advantage

2007-08-08T00:27:00.000-04:00

Curious as to exactly how my representative, House Minority Leader John Boehner (R), feels about the SCHIP issue, I took a gander over to his official website. A line of his statement caught my eye:

"14,267 seniors currently benefit from Medicare Advantage and 73 percent of them will lose their benefits if the Medicare cuts in the House bill become law."

Mr. Boehner, I think you need to revisit your logic.

The fact of the matter is that while enrollment in employee-based health insurance programs is at all-time lows for the major health insurance companies, and cost of care is at an all-time high, insurance firms are still seeing record-breaking profits. A few examples:

Humana's profit more than doubled to 19% last quarter despite an 11% loss of enrollees in employer programs. Why? "About 59 percent of Humana revenue in the second quarter of 2007 came from Medicare programs."
Wellpoint lost 108,000 employment-based beneficiaries last quarter but still managed a 11% rise in revenue. The reason: "Expanded enrollment in government-funded programs and tighter control of costs."
UnitedHealth Group profits rose 22% while losing 10,000 customers in employer programs. The cause: "The boon UnitedHealth has seen from increasing the profitability of its Medicare programs for the elderly."

It is clear that the 12% overpayment to private insurance companies by the Medicare program is directly subsidizing huge profits. But Mr. Boehner's argument still stands: will cutting the subsidization reduce benefits for seniors?

It is true that private fee-for-service programs offer seemingly admirable benefits such as dental and vision coverage, specialty services, and even gym memberships. But these attractive benefits mask the lack of coverage for more serious issues.

Testimony given by Dr. Patricia Neuman for the Kaiser Family Foundation reveals that these private fee-for-service plans lack certain essential benefits covered by traditional Medicare. The KFF discovered that enrollees in these private FFS plans would in fact pay extensively more for procedures, hospital stays, prescriptions and skilled nursing facility usage than under traditional Medicare.

Additionally, AMA Trustee Dr. Robert Wah's testimony unearths an even more alarming aspect of this issue. Aggressive and unfair marketing techniques utilized by the plans intentionally mislead Medicare patients to enroll in private FFS plans without adequately disclosing the unfavorable terms. 37 of 43 states received complaints that inappropriate marketing techniques were used to enroll beneficiaries without their full understanding of the consequences of their decision. These plans take advantage of the population they cover by specifically targeting and misleading vulnerable seniors - in fact, beneficiaries with cognitive impairments make up 25% of the enrollees in private FFS plans.

So the question remains. Would seniors be disadvantaged from cuts to private FFS plans? If the cuts forced them to return to traditional Medicare, they would probably be better off.

CHAMP: Access to Care vs. Specialty Interests

2007-08-07T01:47:00.000-04:00

A recent correspondence with a fellow classmate has prompted me to address the darker, undiscussed aspects of the House's SCHIP bill, Children's Health and Medicare Protection Act of 2007 (CHAMP).

The countering issues contained within H.3162 adequately demonstrate the complexity of the issue, and certainly make it clear why the AMA can't be "the voice" for all physicians simultaneously. From my short time on the Hill, I certainly learned that just about every piece of legislation contains its caveats, and that makes it difficult for physicians to unite behind a single bill.

In contrast to the benefits of this bill outlined in my previous posts, this bill additionally imposes restrictions on physician-owned hospitals. It would prohibit any patient referral by a physician to a hospital of which the physician has partial ownership. This practice seems to be gaining momentum after the repeal of a similar ban in 2006 in an attempt to provide patients with specialty medicine options, avoid scheduling conflicts, and allow continuity of care.

Medicare Payment Advisory Commission (MedPAC) itself admitted that physician-referred Medicare patients receive quality, cost-effective care at such institutions, and such referrals pose little ethical dilemma in terms of conflict-of-interest. The AMA worked hard to get the similar restrictions lifted in 2006, and it would be a shame to see it happen all over again. The problem lies in the public's distrust of physicians' motives - at first glance the issue appears to present an opportunity for personal financial gain for hospital-owning physicians. However, the practice of medicine is bound by ethical and moral guidelines which I would like to believe (perhaps naively) all physicians adhere to. Perhaps Congress' distrust of an ethical obligation lies within an internal reflection of their own professional practices.

Other provisions of the bill that do not sit well with physicians are the imaging reimbursement cuts and the division and allocation of medical specialties into six separate but interdependent Sustainable Growth Rate (SGR) categories. Dividing the SGR into six distinct entities would limit the growth rate of some specialty fields while providing more funding for others. However, the growth of certain specialties is not physician-dependent - it's regulated by patient demand. Therefore, limiting growth of expanding specialties would have a direct, negative effect on patient access to adequate care.

Even the Medicare Advantage (MA) cuts used to fund the SGR update tend to be disagreeable among some physicians. Although most of the overpayments to private fee-for-service programs are directly absorbed by insurance companies, many physicians, especially in areas like Oregon where MA overpayment rates tend to be the highest, fear that cuts in payments to their payers will be passed on to them.

This issue exercises a balance between drawbacks and merits. While on one hand, subgroups of physicians may be negatively affected by reimbursement cuts and restrictions on referrals, the other depicts a different, larger picture. This bill will significantly increase access of care to millions of children while simultaneously preventing major reimbursement cuts to most doctors. Of course this is not justification for the drawbacks of the bill, nor is it support for them, but it must be given weight when determining the most acceptable outcome.

Also visit http://www.acr.org/HomePageCategories/News/ACRNewsCenter/HousePassesSCHIP.aspx for more information on the imaging cuts and SGR division.

SCHIP Update

2007-08-02T13:46:00.000-04:00

Well I came into the office today because I just can't get enough of this place and I needed to write up a report to get paid/credit (but mostly for the free lunch that was offered by my fellow worker-friends). I found out that the House's SCHIP bill passed the House last night with a vote of 225-204 (with 5 R's voting "yay" and 10 D's voting "no") - great news but the numbers are not high enough to counter a Presidential veto.

The bill passed virtually untouched. It includes the $0.45 cigarette tax, the Medicare Advantage cuts, and the SGR fix. Of course the Republicans were all opposed because they tend to think this will lead to a single-payer system, and the Democrats are happy because children won over big tobacco.

Just to bring it home a little, John Boehner, one of Dayton's 3 representatives and House Republican leader stated:

“This is a very partisan bill, done in a very partisan way. It expands government-run health care beyond anything any of us could have imagined in the last 10 years.”

Republican Pete Sessions agreed with Boehner, saying:

“The bill uses children as pawns in a cynical attempt to make millions of Americans completely reliant on government for their health care needs.”

Mr. Sessions, you'll have to forgive me, but isn't it better to make millions of children completely reliant on government for their health care than have none at all?

So, it's a good day for doctors and my fellow doctor wannabes, and an even better one for our kiddy patients. But, of course, we still have to wait and see how this one turns out down the road.

*** One last morsel for your ruminitive mind***

"People have access to health care in America. After all, you just go to an emergency room."

- President Bush's rationale for threatening an SCHIP veto.

PDUFA (pŭh·doo·fŭh)

2007-07-27T15:30:00.000-04:00

Today is my last day as GRIP. However, I have told my office that odds are good I'll be in next week to wrap some things up (a.k.a. I'm lazy and don't feel like emptying my desk right now). All-in-all, this experience has been one of the most enlightening experiences of my life. I have gotten a glimpse into a world so foreign from my former (and soon current) one at med school, I actually feel like I've been abroad for the past two months not unlike the majority of my classmates.

As this is my last day, however, this will not be my last post. I will continue to express my thoughts on health policy in the future and use what I have learned here in the AMA office as reference.

On that note, I will now turn my attention to the Prescription Drug User Fee Act (PDUFA) Reauthorization. PDUFA, originally passed in 1992, requires drug companies to pay the FDA a fee whenever the FDA has to review a new drug. These fees help offset the costs brought about by the approval process. Every 5 years, like SCHIP, this user fee act must be reauthorized - else, the FDA loses almost $300 million a year, there will be major layoffs and drug approval and safety monitoring would be crippled. Clearly this would be an unacceptable fate - even the payers of these fees, the drug companies themselves, don't want this as it would destroy the approval process.

Just like everything else, however, there are some caveats. The user fees have substantially increased FDA employment and significantly reduced length of approval periods. This is good, especially for drug companies, but it has resulted in an unintended consequence. Researchers involved in the approval process feel pressured to churn out drug approvals as quickly as possible. This has caused a significant drop in employee morale at the FDA recently - many researchers have testified that they are pressured to approve drugs despite any negative consequences they may find.

The issue becomes clear when the situation is boiled down to its simplest forms - drug companies pay the salaries of those who are responsible for protecting the public from any potential harm. Conflict of interest, perhaps?

The last reauthorization (in 2002) touched on this issue by setting aside more money for clinical trials, safety studies and market surveillance after a drug is released. Current proposed PDUFA legislation would set aside even more money from user fees for safety and market surveillance functions, as well as remove those with conflicts of interest on approval committees (having financial ties to the pharmaceutical industry) and prohibit direct-to-consumer advertising (Because, after all, what patient needs to ask their doctor for a specific drug by name? Shouldn't it be the doctor's decision? Isn't that why there's med school?). The new legislation would also increase user fees by $150 million per year, a figure that was actually agreed upon by the pharmaceutical companies.

The AMA's stance on the issue of user fees is fairly neutral. We have no policy regarding user fees, so we don't have an official position. Speaking on behalf of the medical community, however, I can point out that this subject is a double-edged sword (hi-yah!) in that without them, the approval process would be slow and life-saving medicines would be delayed getting to market. With them, the FDA has the pressure of pleasing their payers.

My one little anecdote about this issue is about a small press conference I attended a few weeks ago. I sat at a conference table with about 8 other people on the top floor of the Kaiser Family Foundation's building. One of the people present was a rep from PhRMA (the pharmaceutical industry's lobbying firm - one of the richest in the country). She looked us all square in the eye and proceeded to explain that user fees had no effect on the approval process and safety surveillance, that direct-to-consumer advertising doesn't affect physician's prescribing habits, and that approval committee members with conflicts of interest do not affect the integrity of the approval pathway.

My question for her is, if paying the FDA has no benefit for the pharmaceutical industry, why is it so willing and forthright to forfeit billions of dollars for it?

SCHIP Day!

2007-07-26T17:35:00.001-04:00

Although I won't have much time to post at my usual length today, I thought I would touch on State's Children Health Insurance Program (SCHIP) in honor of the fact that half of my office has been on the Hill for two simultaneous mark-ups in the House Energy and Commerce Committee and Ways and Means Committee.

SCHIP is a national program designed for families who earn too much money to qualify for Medicaid, yet cannot afford to buy private insurance. It specifically offers health coverage for, well, children. Every five years, SCHIP must be reauthorized by Congress or else the program will lose funding and cease to exist. The program has brought much benefit to this country's health, and no member of Congress or President would ever (hopefully) let it expire.

Currently, there are two SCHIP bills in Congress - one in the House and one in the Senate. Both bills would greatly expand coverage, a fact that Dubya has made clear he is not a fan of by threatening a veto if either pass as they are currently worded. Both bills call for more funding, and both would create a cigarette tax to pay for such expansion. This tax, in addition to the idea that an expanded SCHIP program may be an initial step towards a single payer system (universal health care), is the reason for Bush's promised veto.

As the AMA supports the House bill, I will focus on that one from here on out.

The House bill calls for a 45 cent tax on cigarettes, which actually has the support of Southern Democrats and the Blue Dog Coalition (conservative Democrats) because it is substantially less than the Senate's proposed tax of 61 cents. The bill also derives funding from cutting Medicare Advantage overpayments, which, as a future physician and not a Big 4 Insurance Company, I am all for. Finally, more cuts would come from reduced Medicare payments to non-physician health providers such as skilled nursing facilities and home oxygen providers. While at first glance this appears to be detrimental to patient health, further review reveals that these providers rake in huge profits and have some of the strongest lobbyists on the Hill (I must admit, however, that I am weary of any cut to the medical industry that may have any negative impact on our health care system). The overall pricetag of the bill would be $50 billion over the next five years, $45 billion more than the President has alotted. And although this cost would be fully funded by said taxes and cuts, the President gets the final say when that bill hits his desk.

Possibly the most noted benefit of this bill for physicians is the fixed Sustained Growth Rate (SGR) formula which is used to calculate Medicare payments to physicians. The SGR is based on a pre-apportioned amount of money for 20 years - so if doctors are overpaid one year, they'll have to underpaid further down the road. Unfortunately, this pre-determined amount of money was grossly underestimated and did not effectively take rising medical costs into account. So while SGR-calculated Medicare payments to doctors has been just enough to cover costs of operation for the past 12 years, the next 8 years will see 40% cuts in payment rates with 10% cuts slated for next year. This severely limits physicians' abilities to see Medicare patients and threatens to force many doctors out of business. The House SCHIP reauthorization bill temporarily fixes this formula to update payments to 0.5% increases in the next two years - a band-aid that wouldn't even match inflation and rising operating costs, but anything's better than 10% cuts.

So stay tuned. These two bills will likely pass as watered-down versions of themselves and then differences between the two houses of Congress will have to be resolved. It'll be interesting to see what remains of the House's original language, and it'll be even more interesting to see if the President remains true to his word and comes through on his promise.

Medicare Advantage - Private Fee-For-Sevice

2007-07-13T10:54:00.000-04:00

Ok, I'm back. I apologize to my faithful reader(s) out there for not maintaining this blog faithfully - things have been quite hectic here and I'm still not used to the whole "blogging experience." And I'm a notorious procrastinator.

Let me catch you up on some of the activities I've been involved in throughout the week. Tuesday I attended a hearing on the Hill to hear former First Lady Rosalyn Carter, Rep. Patrick Kennedy, Rep. Jim Ramsatd, David Wellstone, and about a dozen others testify on the issue of mandating health insurance policies to cover mental illnesses (including substance addiction). What made it particularly interesting was that many of the testimonies were based on first-hand experiences, such as Kennedy and Ramstad's alcoholism. Other things I have been entertaining myself with include researching physician identity fraud, developing a survey evaluating why students choose particular specialties and localities, and trying to figure out ways to better communicate health policy issues with students.

And now onto business:

Today, we tackle Medicare Advantage (MA). Specifically, the fastest growing and most controversial aspect of MA: private fee-for-service (PFFS). MA was brought into existence by Part C of Medicare (not to be confused with the controversial drug-covering Part D). This section of Medicare allows private companies such as United, Blue Cross Blue Shield, Humana and Kaiser to arrange care for Medicare beneficiaries enrolled in the plan. PFFS is a specific system used by these private companies to arrange and pay for care. There are quite a few benefits to this. Enrollees can go to any doctor who is willing to accept the PFFS plan, which usually allows much more flexibility in treatment options than Medicare's traditional fee-for-service (a.k.a. regular Medicare) can supply. This flexibility can allow beneficiaries to seek specialized care, and can also solve the geographical problem of rural health care: more doctors accepting a beneficiary's plan means less travel to get treated (which can be quite significant when you're in the middle of Wyoming). And perhaps the greatest predicted benefit of PFFS: private companies responsible for maximizing beneficiaries' care for what they're paid by Medicare while simultaneously maximizing profits means increased efficiency and less cost per beneficiary.

So all-in-all, PFFS sounds like a great plan. But of course, as with everything here in D.C., there are countless sides to the story. Let me give you the AMA's side (and, coincidentally, the side of just about every physician and patient organization).

When MA was first introduced, Medicare paid the exact same amount for PFFS as they did for traditional fee-for-service per beneficiary. This forced companies to be competitive and maximize profits by trimming costs while still attracting enrollees. This, however, has led to an ethical breakdown of these PFFS companies. The AMA has received innumerable complaints from physicians and patients that PFFS companies are misleading and deceptive. Their plans are intentionally complicated to confuse the enrollee, and often the "fine print" contains exceptions that exempt the payer from covering certain essential events. For instance, many of the plans include dental and vision benefits to attract enrollees, but will fail to cover chemotherapy and radiation therapy (of course, this is not well advertised to the enrollees when they sign up).

On top of these concerns, through effective lobbying of the Department of Health and Human ServicesPFFS companies have convinced the paying governmental party that they need more compensation per beneficiary than is allotted for traditional fee-for-service. Currently, PFFS is paid 112% the cost to cover typical Medicare beneficiaries. This 12% is an average amount - some localities and companies can be paid up to 150% the cost of typical Medicare fee-for-service! This means that a system that was intended to save the government money on Medicare has actually ended up costing more (not surprisingly...).

But what has MA done for patient care? Besides saving money, MA was supposed to increase care for patients. But as I outlined above, many of these PFFS companies use unethical shortcuts to save money, resulting in worsened care. Studies have shown that although more money is being given to PFFS per beneficiary, they are receiving equal or lesser care than that given to beneficiaries of traditional fee-for-service. And equally unscrupulous, the 12% increase in cost to the system is not reflected in physician reimbursement. So where does this 12% go? The pockets of the PFFS companies.

Now, I don't want to come off as extreme. This is not Sicko, and I try to represent the facts. There are indeed some advantages to PFFS, as I mentioned earlier. PFFS certainly improves access to care for many beneficiaries, especially those in rural settings, and allows specialized care not typically covered by traditional fee-for-service. It's just important to keep in mind that while PFFS companies will rely on these benefits to reason for their existence, there is a price being paid.

That said, this price offers a prime area for Congress to make cuts. Right now, legislation which would fix the inadequate Sustained Growth Rate (SGR) and the State Children's Health Insurance Program (SCHIP) is being debated in Congress. SGR determines how much physicians are reimbursed for Medicare (and of course, we need more) and SCHIP is insurance that covers kids. So, cutting MA spending offers a prime target for Congress to release the funds necessary to fix both of these programs.

I should note here that the AMA's stance is not to get rid of PFFS, just make payments equal to traditional fee-for-service and, of course, no unethical or misleading methods of winning over potential enrollees should be utilized.

As enrollment in MA is already substantially high (19% of Medicare beneficiaries are enrolled in MA), and as PFFS enrollment continues to make up an increasingly significant proportion of MA beneficiaries, expect to see much more debate as to the legitimacy and sustainability of this program.

See the Alliance's Toolkit for Medicare Advantage or the Kaiser Foundation's nifty little Medicare Advantage video tutorial.

Have a good weekend.

Biologics

2007-07-09T12:40:00.000-04:00

So, now that I've had some time to think, I have come up with a game plan. Every day or so, I will post something about an issue I have been working on. Today, I will focus on biologics, as it is the topic which I have focused most on since being here. I gave a short-but-sweet presentation on biologics at the Annual Meeting in Chicago to the Council on Legislation (COL).

So first, let's define biologics. Biologics are drugs. Not your typical drugs like morphine and penicillin, but complex drugs. They are typically entire proteins and are huge in size, and have a very complicated, difficult-to-reproduce structure. They are difficult to reproduce because, seeing as they are proteins, they are usually synthesized by a living organism such as bacteria using bioengineering techniques and can have any number of post-translational modifications. Insulin and erythropoietin are examples of biologics. So what do you think this does for the price of these drugs? That's right, they're expensive. Treatment with these drugs can cost upwards of $100,000 a year. And they can treat any number of fairly common diseases like diabetes, rheumatoid arthritis and anemia. So Medicare (and therefore Congress; but also physicians and patients) is looking for a way to cut down on these costs.

To cut down on costs, there needs to be competition. Biologic generics, or biosimilars, would potentially save patients and taxpayers alike from these high bills. However, there currently is no legislation in place to allow an abbreviated process for biosimilars to be approved after the original biologic's patent expires. This means that to come out with a biosimilar, the manufacturer would have to go through everything that the original manufacturer did - the red tape, the clinical trials, the analytical tests, everything (currently, for "small molecule" drugs, as long as a generic drug is proven to be identical to the "reference product," or original drug, the generic company doesn't need to prove it's efficacy and safety. They can just reference the original company's research). This would not cut down on price at all. So, enter Congress...

There are currently 4 bills in Congress right now to pave the way for an abbreviated approval process for biosimilars, and it appears that one of them, the "Biologics Price Competition and Innovation Act of 2007" led by Senator Ted Kennedy seems to be gaining enough momentum to pass. The reason it's good is because it allows an abbreviated approval process that would make it cheap for biosimilar producers to make generics, but it also preserves a set amount of time through patents and exclusivities for the reference biologic to incentivize companees to invest in researching and developing new, groundbreaking drugs. It's very similar to the Waxman bill 20 or 30 years ago that paved the way for generic drugs - the one we will all take advantage of in a few years when we go to CVS to buy the cheap version of the little blue pill.

So what's the problem? Where's the controversy? At first glance, this bill seems to make everyone happy - patients get cheap drugs, insurance companies pay less for treatments that were previously cleaning them out, drug companies still have at least 12 years to take as much advantage of the market as they can, and this all leads to doctors being more able to prescribe life-saving treatments.

The problem lies in that because biosimilars cannot be identical to the reference product due to the complexities of the production process, they can pose a health risk due to allergic response. A patient can be doing fine for years on the reference drug, and then one day they may switch to the generic and develop an anaphylactic response. The scariest part about these bills is that they grant the possibility for the reference product to be swapped out for the generic by someone other than the physician (thanks to ill-defined "therapeutic equivalence" standards). This would mean the pharmacist at your local pharmacy would automatically give you the generic when in fact you may be allergic to it. Insurance companies would also of course require the generic to be substituted because of cost, and the patient and doctor would have no say in the process, even though the generic could be less safe. It takes control of the patient's well-being out of the hands of their physician.

As this bill flies through Congress at breakneck speed, legislators do not seem to be concerned with patient safety. The bottom line is that this bill claims that as long as the drug has the same function and mechanism of action as the original, and it's relatively similar in structure (but not identical), they can be substituted for each other. However, as any med student knows, the slightest change in structure can result in a catastrophic allergic response - a safety concern that should never supersede a physician's prescription.

My First Post...

2007-07-09T09:36:00.000-04:00

Well, this is my first time posting as a blogger. To be honest, I'm not even a big fan of "blogs" - I never really understood why people feel compelled to make their thoughts public property. But, for the sake of passing on a few gems of wisdom (which, in my case, are few and far between), I will concede to jotting down a thing or two when the opportunity presents itself.

I have now been working in the AMA Washington, DC office for 4 weeks, and I'm only slightly less confused than the day I started working here. The new Government Relations Advocacy Fellow - he prefers Kunal - started today. I see the beleagured look on his face that has been plastered on mine for the past 30 days. It's nice to have a familiar face around. He just asked me what it is that I "do around here," to which I simply responded, "I don't really know." Not to sound like I'm inept or the job doesn't offer anything - it's just that so much goes on around here that I get thrown in the whirlwind and am somewhat oblivious to what I'm doing. I am, however, learning a ton.

Let me give some examples of what it is that I do. My schedule today is:

9am - Staff meeting in Board Room. Here, every division head in the office talks about what's going on this week. It seems like this week is going to be a busy one. The different divisions are Federal Affairs, Media Relations, the lobbyists, and Legislative Counsel - I work in Legislative Counsel. Some other time I will give a breakdown on what the different divisions do.
9:45am - Division meeting. The lawyers in my hallway and I sit in a room and discuss our schedules for the week and what we're working on.
10am - Conference call on tamper-proof prescription pads for Medicaid patients. The CMS (Center for Medicare and Medicaid Services, a division of the Department of Health and Human Services [HHS]) will require physicians to use tamper-proof pads by October of this year. There are several things we do not like about the requirement that will negatively impact both physicians and Medicaid patients, and so we let the CMS know about them. Whether or not they listen, however, is a crap-shoot.
noon - Luncheon meeting sponsored by the Alliance for Health Reform at Union Station. This meeting will address presidential campaign issues relating to health care, as well as where the candidates stand (currently).
2pm - Update meeting in the board room. Specialty societies will be calling in to this conference call to let us know where they stand on things, and we will let them know what's going on.
5:45pm - Council on Legislation (COL) executive committee call. Don't ask.

Some things about my schedule bring up a few points I'd like to make. Number one, I don't think I'm getting reimbursed for my travel because I don't have an XMS account set up. What's an XMS account? Good question. Number two, sometimes I have to be vague in my details. Sorry, this isn't because I'm lazy (although many would argue that this is, in fact, the case). I have been held to strict confidentiality guidelines regarding a lot of the stuff we do here. I don't exactly know why, but I assume it has something to do with spoiling our plan of attack on some issues. It's really too bad though because the confidentiality aspect tends to mask a lot of the things we're trying to achieve for docs. If it doesn't seem like we're working on an issue that will impact health care, you can bet we are, we're just playing the hush-hush game.

And number three - my girlfriend, and probably only reader (hello, Brianne), claims that I am in a cult. I will be the first to admit that this is probably the case. The AMA is a group of people dedicated to serving my profession. Everyday, I work with lawyers and lobbyists who continually push for what is best for the medical profession and its patients. I had no idea an organization with such deep pockets could ever be founded on ethical principles and maintain those principles without corruption. I never thought that I would like and respect a lawyer until I met the ones in my office. I believe in the AMA's mission and will support it anyway I can. Yes, Brianne, I am in a cult. But hey, I don't think there's any Kool-Aid around (just free Diet Coke - oh yeah!).

Now I see why people blog - you can preach all you want. Although no one is probably listening, anyway.

So, for the rest of the summer, I'm going to try to put up stuff that's helpful and insightful (hopefully). I will also try to give links that will fill you in on current health care policy. Hopefully somebody will be reading this by the end of the summer, but if not, I suppose it's fun to type for typing's sake. God, I'm lame.