Testimony of Peter J. Pitts - NY State Assembly

Friday, February 1, 2008
Testimony of Peter J. Pitts before the New York State Assembly
President Center for Medicine in the Public Interest

My name is Peter Pitts. I am the President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.

Mark Twain said that for every complex problem there is usually a simple solution – and it is usually wrong. I believe that, while the intent of the various pieces of legislation under discussion today, is well-meaning – they are poorly designed and that any short-term benefits would be significantly outweighed by many unintended consequences.

 First let me first address Bill A. 7645 and the issue of prescription privacy.

Whether or not physician-prescribing data should or shouldn’t be available for marketing purposes is one thing, but the most important thing to remember is that there are important public health reasons why this data must continue to be shared with biopharmaceutical companies.

When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters sent by drug companies to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients are taking a specific drug and for how long each patient has been taking it.

Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.”

In July of last year, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation. Next I would like to address Bill A. 7468 and the issue of drug manufacturer disclosure.

 First, three obvious but important points:

1. The proposed legislation potentially violates federal trade secret laws because confidential marketing information would have to be disclosed;

2. The proposed legislation epresents unwarranted government interference that could decrease competition. It is important to note that no other industry in New York has to disclose marketing efforts; and

3. The proposed legislation unnecessarily adds to compliance costs and duplicates voluntary guidelines already established by the biopharmaceutical industry.

But here's a bigger question -- if transparency is a good thing when it comes to biopharmaceutical company payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits? Insurance providers like AARP.

Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?

It's not in Bill A. 7468.

Or what about transparency regarding how state government is leveraging a physician's prescribing habits via regulation?

Also not in A. 7468

It seems the grass is always greener when it comes to slamming the biopharmaceutical industry -- but that everyone else with an open wallet (or a tight wallet in the case of state government) gets a free pass. If transparency is good for the goose then it's good for the gander.

Let me now address Bill A. 2274 and the issue of clinical trial registries. And here’s my first question, why? Is it supposed to replace the comprehensive federal database at clinicaltrials.gov?

Is it to make sure that the biopharmaceutical industry isn’t hiding anything? If that’s the case, then I recommend you visit the web sites of every large biopharmaceutical company – where they post the results of all their clinical trails.

Eli Lilly was the first to do this -- a fact that mysteriously never made it into a recent New York Times story on clinical trial transparency.

If the reason for A. 2274 is to make sure that every local general practitioner has access to information they can use to better treat their patients, I recommend that the members of this committee spend one hour looking at clinical trials results.

They are not user friendly. And when biopharmaceutical companies have tried to present abbreviated results, they’ve been accused of “hiding” negative data.

Rather than focusing on redundant clinical trial registries, I believe the Assembly should focus on ways to work with the various players in the health care industry to facilitate the sharing of information – specifically via electronic medical records – as well as to get patients enrolled in existing biopharmaceutical assistance programs. While it’s politically popular to be antagonistic towards the industry, leading a collegial effort towards success is what is in the best interest of the citizens of New York.

My remaining comments will be directed towards Bill A. 3848 and the issue of prescription purchasing.

The first point I’d like to make is that there seems to be a basic misunderstanding as to the burden of cost. One of the justifications for this piece of legislation is that prescription drugs “place a burden on health insurance plans.”

But consider this – while it’s true that insurance companies have been increasing their monthly premiums — it’s not because prescription drugs costs are busting their budgets. Prescription drugs account for only a small part of monthly insurance-premium increases.

From 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48. What about the other $82.14? That’s a good question. And New Yorkers deserve an answer.

The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.

This imbalance has had a devastating impact. Out-of-control out-of-pocket expenses have caused many patients to stop using prescription drugs for controllable chronic conditions like high cholesterol, high blood pressure, ulcers and depression.

The unfortunate result among patients with diabetes, asthma, and other chronic diseases is that visits to emergency rooms have increased 17 percent and hospital stays have risen 10 percent.

I believe our state would be better served with programs that provide more chronic care to more New Yorkers.

Bill A. 3848 also uses as a justification the need to assist those Part D participating New Yorkers who fall into the so-called “donut hole.” I believe that our tax dollars would be better spent educating these Medicare-eligibles to the 179 Part D plans in our state that offer donut hole coverage.

At the heart of this piece of legislation, in my opinion, is the belief that on-patent prescription drug spending is the problem. I believe it is part of the solution. There is no evidence, none, that generic drugs are being under-prescribed. In the New York State Medicaid program, when appropriate generics are available, they are prescribed 95% of the time.

As to medicines where no generic is available, these are increasingly the first, most effective, and most cost efficient treatment options because it keeps New Yorkers out of the hospital, at work, paying taxes and living productive lives. As to the mistaken concept of “Me-Too” drugs, I could speak for another hour – but suffice it to say that it is a myth. Is spending on biopharmaceuticals up? It is, because more drugs are being appropriately prescribed. And the result is a healthier New York and a reduced burden on our state’s health care system.

It’s not about the price of drugs; it’s about the cost of health care. As Disraeli said, “It is easier to criticize than be correct.”

The argument that health care is "too expensive" is too broad. We need to focus on prevention because that's the best way to save money and improve lives.

And considering that prescription medicines represent but 4 percent of the New York State health care spend (4 cents on the NY health care dollar), it's a wise investment.

The repercussions of short-term thinking vs. long-term results, of state-imposed price controls over patient-based care, are pernicious to both the public purse and the public health.

THANK YOU.