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Pharm Exec Q&A: A Soft Spot for Whistleblowers


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-09-01-2006
Volume 0
Issue 0

If I ran the FDA, I'd have a Rose Garden ceremony for all the histleblowers in my agency. No one can know where all the skeletons are buried. We ought to honor every one of those patriots.

As chairman of the Senate Finance Committee, Senator Charles (Chuck) Grassley, a Republican from Iowa, wields enormous clout in Washington. His committee oversees taxes, international trade, Social Security, and Medicare. Grassley keeps close tabs on agencies charged with executing Congressional mandates, including FDA. If it cozies up too tight with the industry, or downplays safety data that he thinks consumers need, the self-described "common-sense Iowan" says he "sinks his teeth in" and doesn't let go until the problem is solved.

The federal government spends hundreds of billions of dollars on prescription drugs each year, and Grassley is determined that US taxpayers will pay only for safe and effective medicines. But investigations and reports by whistleblowers have convinced the senator that FDA does not protect the public as it should. He has accused the agency of "sweeping safety data under the rug" when it looked at antidepressants for children, ADHD drugs, and Merck's painkiller Vioxx (rofecoxib). Not to mention the "runaround" he gets when he asks for information on the side effects of Ketek (telithromycin), an antibiotic by Sanofi-Aventis. Grassley backs legislation to overhaul FDA's drug-safety reviews, liberalize curbs on drug imports, and eliminate conflicts of interest. He says safety comes up short in DTC ads, and he wants FDA to better protect patients in clinical trials.

Pharmaceutical Executive's Washington correspondent Jill Wechsler recently discussed these and other concerns with Senator Grassley. The Senator emphasized that FDA needs new permanent leadership, but hedged on whether he thinks Andrew von Eschenbach is the right man for the job. Those he does like: whistleblowers great and small.

Pharm Exec: Why do you think FDA is in trouble, and what would you do to fix it?

Grassley: As a starting point, Senator [Christopher] Dodd and I have introduced legislation that offers some improvements. One bill would require that all clinical trials—both positive and negative—for all drugs would be posted on the Internet so that all the information would be made public. The other bill would make the Office of Drug Safety [recently renamed Office of Surveillance and Epidemiology] entirely separate from the Office of New Drugs.

That's the legislative piece. From the standpoint of the agency itself, in most of the last six years, it hasn't had permanent leadership. So getting a commissioner that will do the job right, and getting him in there full-time, is important.

You have talked about a broader cultural problem within FDA. Why is that a concern?

There is a culture within the FDA that's more worried about its public relations than it is about patients. Now I can say the same thing about the FBI, and I have. It may not just be an FDA problem, but a culture problem in all government. You see it, for instance, when the Office of New Drugs approves something, and the Office of Drug Safety raises questions about it. The Office of New Drugs doesn't want egg on its face, so it tries to squash the controversy.

In the end, you lose proper respect for the scientific process. For a non-scientist like me, that means if you have a good idea, it should be subject to peer review so that the science will prove if it's right or not. In the case of FDA, the key issue is whether the drug is safe and effective. But dissident points of view are not getting proper respect. Events have proven that they were right: We see that Vioxx is off the market and that antidepressants for kids have a black box. But the scientific process has been compromised, and it's all about the public relations of the organization.

And lastly, it seems to me, the relationship between FDA and pharmaceutical companies is too cozy. We see evidence of this in some of the telephone notes and e-mails we've had access to. It's just not right. The only person that should be across this table from the FDA is John Q. Public. It seems like FDA officials see themselves too much as facilitators working with the drug companies—instead of regulators.

Is that too-close relationship with industry aggravated by FDA's increased reliance on user fees?

Well, there was a good purpose for putting user fees in place. About 15 years ago, the drug companies were complaining that FDA was moving too slowly. We came to the conclusion to speed it up, but had to have resources to pay for it. So we decided to let the drug companies pay for it. I'm willing to accept the idea that just because they're paying for it doesn't give them an inside.

You have proposed a separate drug-safety office, but FDA officials and others fear that such a move would shift the risk/benefit assessment too much to the risk side.

You get back to how the scientific process works. If scientists say a new drug is safe, they've got to have scientific evidence to back them up. When a drug goes on the market, the scientists in the Office of Drug Safety also have to proceed in a scientific way. In each instance there doesn't have to be any relationship—each group just has to do its job.

Do you think Congress will approve legislation on drug safety?

The Senate HELP Committee [Health, Education, Labor and Pensions] has a bill that is trying to accomplish many of the same things that I'm trying to accomplish. But I don't think they do it in the best way. They don't call for a separate drug-safety agency.

If some of the ideas I want to get accomplished don't [move forward], I would use almost any vehicle to get them accomplished. The legislation doesn't necessarily have to go exactly my way, but it has to accomplish the same ends.

No "facilitator," please

You mentioned that FDA needs permanent leadership, but you have not been very enthusiastic about the current nominee. Do you think the acting commissioner could address some of your concerns if confirmed?

I was disturbed by some reports we received that at an FDA meeting about Ketek, he [Andrew von Eschenbach] described the drug's approval as one of "our greatest hours." But this was a case where the scientists had raised all these safety questions, and someone higher up had overridden them. I also hear about him bragging about being a facilitator; anyone who sees himself as a facilitator for the drug companies is not looking out for John Q. Public the way he should.

Now—will I vote for him or against him? I don't have my mind made up on that. But I will say this: I've had several meetings in my office with him where it seemed to me that, yeah, he's the guy who has the right attitude. But then I hear rumors about what I just described to you, and it raises questions about pandering.

The main issue holding up von Eschenbach's confirmation is that FDA has moved too slowly to approve broader access to the morning-after pill. Do you see evidence of politics interfering with FDA deliberations?

Even though I might agree with the [interference of] politics, I would have to turn it around and say that I'd have to apply the same standard to that as to anything else. If the scientific process has played out and safety and efficacy is proven, I can't have two standards of science—one for a drug I might agree with and one for a drug I don't agree with.

Your drug-safety bill also proposes changes in how FDA regulates drug advertising. Are you concerned that DTC ads raise safety issues?

I've watched so many of these commercials and feel that the dangers [of drugs] are not as obvious as they ought to be. When the person presenting the commercial gets to the lines about safety, they go very very fast. It just seems to me that that compromises the safety issues of some drugs. And so I'm not looking at it from the standpoint of whether there ought to be drug advertising or not. I'm looking at it from the standpoint of it being effective advertising regarding drug safety. We have asked the Government Accountability Office to examine DTC advertising on safety issues. A report should be out early next year.

Your legislation proposes a two-year moratorium on DTC advertising for new drugs, as well as specific language on safety in advertising. Would that address safety concerns?

Yes. It seems to me a natural extension of drug safety: If there's information going out on the use of a drug and there are some dangers connected with it, those dangers should be as prominent as the promotion of the uses of the drug.

Medicare success

You have been a major proponent of the Medicare drug benefit. Has it lived up to your expectations?

It has worked out better than we expected. Back during the negotiations in 2003, we were worried sick over how realistic it was to have a $35-a-month premium. But competition has brought premiums in at $23. We were worried about whether there would be enough plans, because in rural America we wanted to have competition and more choice. And now there are 44 plans in Iowa.

And then you even get added benefits. You know we have the problem with the doughnut hole. To fill it would have cost $400 billion dollars—twice as much as the rest of the program—to take care of 12 percent of the people. Now we have plans that don't have doughnut holes, and we didn't even force it on them.

Despite this good news, do you see aspects of Part D that need further improvement?

Pharmacists are not being treated right. There's no reason why these plans can't pay up within two weeks, so the cash flow is not so bad. I've sent letters to CMS [Centers for Medicare and Medicaid Services] proposing just that. If we don't get this done, we may lose a lot of community pharmacists.

Do you still support relief on the late-sign-up penalty?

It's needed because there are up to two million people who might want to join, and they can't sign up until November. So I'm willing to forego the penalty just once—not beyond this year—to get more people under the umbrella. Then you've got a better program that is more effectively financed. And I've introduced legislation to do that.

One success has been to encourage drug manufacturers to continue Patient Assistance Programs for Medicare patients. Do you feel that industry is fulfilling its promises in this area?

I think almost every company is moving toward cooperation in continuing their programs through the doughnut hole. I think our inspector general is trying to accommodate that. There are some companies more aggressively cooperating than others. Prior to the meeting we had in this room, around the first of May, we had the opinion that most of these companies wanted to get rid of the programs, that they didn't want to have anything to do with them. After our consultation with them, the companies are trying to accommodate the people who need the drugs but can't afford them. So I'd have to say that they're going in the right direction. What I see now is a healthy attitude on their part, and I think we've got the inspector general coming around to say it's legal. And I didn't have to get 51 votes to get it done.

Do you expect other changes in Medicare?

There are people who are sort of enemies of the whole thing, who tried to kill our bill. And now they're coming back trying to have the government negotiate. How much better can the government negotiate when the plans are negotiating the average price of a drug down between 18 and 23 percent and generics down by around 50 percent? You can't do much better than that. There are some people who think the government can negotiate, but we didn't want the bureaucrats between you and your medicine cabinet.

We have the example of the Veterans Administration administering drug prices. But you find out that the VA doesn't pay for every drug. One thing we wanted to do was make sure that every Medicare drug-plan formulary had every drug category in it—so that the doctor could prescribe what he thought was best for the patient.

Imports produce competition

Despite the success of Part D plans negotiating lower prices, you have raised concerns about drug prices being too high.

That comes from a lack of competition because we don't allow importation of drugs. I believe in the importation of safe drugs, with FDA approval of the manufacturing and distribution systems in other countries—just like we do for meat we import from other countries.

But FDA says it's impossible to regulate drug imports.

We don't say that about meat. And we can do it even better with drugs because we can put in computer chips that determine if they're fake or not when they come through a port of entry. We ought to be using these new technologies for the benefit of our consumers.

Manufacturers say it will take 10 or more years to do that.

Well, industry doesn't like competition. One problem is that our consumers are paying for all the research that goes on. But why not have the Germans and Canadians pay for some of the research? If we have competition to drive down the price of drugs in this country, and the drug companies then didn't have enough money for research, they wouldn't sell the drugs so cheaply to the Germans and Canadians.

If you were head of FDA, what is the first thing you would do?

I'd have a Rose Garden ceremony for all the whistleblowers within my agency. No commissioner can know where every skeleton is buried, so he ought to honor those who are patriotic enough to make sure the laws are faithfully executed and the money is spent according to Congressional intent.

The whistleblower law should be strengthened, but it's doing a great deal of good right now. There's a great deal of pressure to get along in any organization. Look what they do to scientists within FDA. They wouldn't let one read a paper at a scientific gathering. Someone was going to get something published in a journal, and they wouldn't let him. What is this—a bunch of school kids? They're grown adults sworn to carry out the Constitution.

How else could the next commissioner restore public confidence in FDA?

Make sure the Office of Drug Safety is not in any way under the thumb of the Office of New Drugs. And I would make sure there's a [record] of every communication that every employee has with a company, that it's transparent.

Does disclosure address your concerns about conflicts of interest?

I think disclosure goes pretty far in dealing with these issues. For members of FDA advisory groups, their relationships with any company should be made entirely public. If you can get the expertise that you need, you shouldn't have any of these people on your advisory committees. But if you can't get that expertise and you need them, then everybody ought to know that doctor X was getting this sort of money from this company to do this sort of work. You can let him render his advice, but it must be entirely transparent on any relationship.

What should the pharmaceutical industry do to improve the regulatory system?

I wouldn't go so far as to accuse them of interfering. But they see FDA as their little clubhouse. It's part of this culture I'm talking about. The culture has to work to protect John Q. Public and not be a facilitator for the industry.

I think the industry is the greatest in the world. And we ought to keep it that way. But just like any industry where your product could be unsafe, it's the government's responsibility to ensure that it's safe and effective. If they do their job, we'll end up with great advances for human medicine.

Common Sense Iowan

Charles Grassley takes pride in being "a workhorse, not a show horse," a "common-sense conservative" who values integrity and tenacity. He boasts that he is the only working farmer in the US Senate (his son runs the family farm now) and that he brought his Iowa work ethic to the nation's capital. He has five children and many grandchildren and has been in the Senate since 1980. He focused on health and prescription-drug issues as chairman of the Senate Aging Committee in the late 1990s, before taking the helm of the Finance Committee five years ago.

One important accomplishment as Finance Committee chair was moving forward the Medicare Modernization Act, which Congress enacted in late 2003 to bring "Medicare into the 21st century." This established the Medicare prescription drug benefit and also extended health plan options to rural areas, a central issue for the senior Senator from Iowa.

Throughout his political career, Grassley has emphasized the importance of Congressional oversight to root out government mismanagement and corruption. In the 1990s he waged a campaign to obtain documents on missing POWs and went after the IRS, the FBI, and the Defense Department. He has investigated fraud involving Social Security payments, waste in the Medicaid program, and neglect in nursing homes. He champions whistleblowers and pushed for the whistleblower protection laws of the 1980s—measures that generated much of the ammunition he uses today to blast FDA management, culture, and policies.

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