Latest Drugwonks' Blog

MS. BS. PS.

  • 02.28.2006

Dr. Bob Goldberg on risk, benefit, patients rights, FDA policy, politics … and Tysabri …

As Steve Usdin the Washington Editor of BioCentury (www.biocentury.com) points outs, “there has been very little debate about the risks associated with delaying or denying access to therapies or who should be empowered to make risk/benefit calculations.” Given the growing transparency of the drug development process, the rapid dissemination of post market information and intense and ongoing involvement patients have in both the clinical trial of medicines and managing an illnesses, the real question is, who should have the right to choose which drugs to use: the political class and their allies in the media, or patients, families and physicians?

Next week when an FDA advisory committee reviews evidence about whether to reintroduce a drug for multiple sclerosis called Tysabri back to market after it was removed in the wake of safety concerns, patients will demand that the FDA take ! into account not only the data about Tysabri’s risks, but the relative risks of taking other medicines such as aspirin or existing MS drugs and the benefits of the new drug itself. Ironically, Tysabri’s safety problems emerged the day when Senator Charles Grassley was holding hearing that sought to blame the problems associated with Vioxx on an incestuous relationship between Merck and FDA regulators. Back then, no one was paying attention to the pain of patients who had to live without Tysabri after taking the drug gave them back their lives.

Now, reminescent of HIV activists, MS patients have taken to the Web to organize en masses to pressure the FDA to respond. They are unwilling to let the political class and the professional fear mongers and those who warn against approving Tysabri because it is not a cure take the right to get the drug from them. Lack of access to Tysabri has caused nearly 8000 relapses — loss of movement, sight, independence — in 28000 patients over the past year. 1300 had relapses so severe that they are now permanently disabled. (Will Chuck Grassley or anyone in Congress hold a hearing on that?)

The FDA’s decision about Tysabri will be it’s most important all year. Jeff Krasner’s excellent piece in the Boston Globe provides a great perspective on all the issues surrounding Tysabri, and his coverage from the very start has, along with Usdin’s, been essential for anyone wanting to get up to speed on how the risks and benefits of medicines debate ought to be addressed. I also urge folks to log into MS Patients for Choice www.mspatientsforchoice.org

It will be interesting to see how the media covers this story.

Knock on Wood

  • 02.27.2006

Henry Miller on Susan Wood and revisionist history …

Susan Wood laments that “our federal health agencies seem increasingly unable to operate independently and that this lack of independence compromises their mission of promoting public health and welfare.” However, Ms. Wood is a fifteen-year veteran of the federal government, which makes one wonder where she spent the 1990’s.

Although there is no question that many of the Bush administration’s science-related appointments and its record leave much to be desired — witness the litmus tests for appointees to science-related positions, distortion of information to consumers about health and safety issues, antagonism toward embryonic stem cell research, and the FDA’s apparently politically motivated decision not to permit over-the-counter sales of the Plan B morning-after contraceptive — the Clinton administration’s blatant perversion of science was even more pervasive and egregious.

As President Bill Clinton’s science and technology czar, Al Gore was entrusted with choosing many top appointees to regulatory agencies, thereby obtaining the leverage to politicize the administration’s policies and decisions. There was no room for dissension or respect for data-driven policy in the Clinton administration, no participation in the marketplace of ideas unless you were a true believer and toed the party line. And on many environmental and public health issues, it was a very radical party line, indeed.

As to the politicization of decision-making, I was a senior FDA official at the time and, like many of my colleagues, was appalled at the willingness of then-FDA Commissioner David Kessler to take orders from above about which products should be expedited and which delayed by regulators. For example, the agency approved a dubious female condom after being informed by the secretary of HHS that it was a “feminist product,” and that delay was not acceptable; and FDA officials went to extraordinarily lengths to look for reasons not to approve biotech-derived bovine somatotropin, a veterinary drug, because the vice-president’s office considered it to be politically incorrect.

BIO Break

  • 02.26.2006

At a recent conference of biotech executives, frustration seemed to be the order of the day with venting the inevitable result. Both are understandable. The remarks (dutifully reported by Lisa Richwine of Reuters and reprinted below) show an industry and an agency engaged in a life-or-death battle. Actually, two life-or-death battles. The first is corporate survival, the second, patient survival. And while saving lives is more important than making money (is it even necessary to say that?) you can’t have one without the other. No biotech industry, no new lives saved, extended, or enhanced.

The general frustration is the on-going dichotomy of predictability versus ambiguity at the FDA. One reviewer deals with a sponsor one way while two doors down data is addressed in an entirely different manner. Predictability is power in pursuit of the public health. And while that’s always been true, today it’s become an urgent public health imperative.

Reform is crucial. Or should I say “critical” … like in Critical Path.

Here’s the Reuter’s article. Read beyond the frustration and the venting and you’ll see an opportunity for greater collaboration between regulators and regulated. A high-wire balancing act? Certainly. But one well worth the effort.

Business as usual is not an option.

Biotechs say FDA ranges from good to ‘horrifying’
By Lisa Richwine

BOSTON (Reuters) — Biotechnology companies trying to get new drugs to the market have had experiences with U.S. regulators that range from productive to “horrifying” as they craft early development plans, senior executives told Reuters this week.

Interactions can vary vastly between Food and Drug Administration divisions that review products and provide guidance to companies long before they seek approval to sell a drug, company officials said.

“We have some very good experiences and we have had some horrifying experiences, where you wonder, ‘Where did that come from?’” Genzyme Chief Executive Henri Termeer said at the Reuters Biotechnology Summit in Boston. “What is reasonable and what is not reasonable differs by individual … It’s quite frustrating,” he added.

FDA officials have acknowledged inconsistencies, or a lack of clarity, from some reviewers during early stages, when companies are seeking input on how to design clinical studies of experimental medicines. They have pledged improvements and launched major efforts to work with manufacturers earlier in the process to help more drugs make it to the market.

The agency holds more meetings than ever with drugmakers, more than 2,000 annually.

“We believe more and better interactions will lead to better outcomes and have invested a lot of resources in these efforts,” Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said via e-mail. The FDA also is providing guidelines on how to develop better applications, he said. Officials will announce other measures to improve the review process soon.

Biotechs can face more challenges than traditional pharmaceutical companies. Many biotechs are small, inexperienced and testing their first product. Their technology may be new and unfamiliar to regulators.

Alnylam Pharmaceuticals Inc. CEO John Maraganore said his company has had “remarkably good” dealings with the FDA on efforts to develop treatments based on a new “gene silencing” technology.

“You can engage them in a science-based discussion … People that run into troubles don” engage them in that type of dialogue,” he told the Reuters Summit.

FDA staff are very responsive on potential breakthrough drugs, said Ariad Pharmaceuticals Inc. CEO Harvey Berger. Having “fast-track” status for promising medicines helps insure regular communication, he said. His company’s employees talk often with the agency in person and on the phone and get answers to questions within days. “I think the key is you have got to have a drug that they see a real opportunity for,” Berger said.

Cell Therapeutics Inc. CEO Jim Bianco agreed FDA staff will move quickly for drugs that are “sexy,” but said less exciting, though still important, medicines can get left behind. His company has been frustrated in its development of a cancer drug, Xyotax, which he described as a traditional chemotherapy medicine with fewer side effects.

European regulators are open to clearing the drug based on evidence it is equivalent to other chemotherapy, rather than superior, because it has less toxicity, but U.S. regulators are not, Bianco said.

FDA staff “are not equipped to handle that,” he said. To the agency, “standard chemo is not what moves the field forward,” he said.

Genzyme’s Termeer said it has become easier to deal with European regulators, who routinely approve his company’s products before the FDA does.

“The Europeans are willing to delegate much more of the process … to expert opinions. Much more of the work is done outside the bureaucracy,” he said.

Remember the January 30th Federal Register notice where FDA said they were going to investigate whether or not coupons in DTC ads were legit because they might “foster consumer misperceptions about the advertised prescription drug product.” Well, they’ve withdrawn it — quietly. When asked why the agency replied, “The agency withdrew the notice because the matter required additional consideration.” Well said. Translated that means (and this is my best guess) that cooler heads in the agency (most likely in the Office of Chief Counsel) pointed out that FDA has no authority to regulate this area.

Good decision. Good press statement. Face is saved.

Plastics.

It was good advice in “The Graduate,” but it’s bad news for internet profiteers masquerading as pharmacists.

Both Visa and MasterCard rules prohibit the processing of any illegal transactions such as those from illegal online pharmacies. Both card companies have issued fines for doing so. Several online pharmacy accounts, in fact, were recently terminated as a result of card Association and member bank pressure.

To do business with online pharmacies it is required that the member bank conduct an investigation for every online pharmacy. This will include providing a copy of the pharmacy’s license, a statement that the merchant’s sales activity is in compliance with all applicable laws, proof that valid prescriptions are required before medications are dispensed and proof that only prescriptions from licensed physicians are accepted.

Any questions?

You can look it up

  • 02.23.2006

The Ol Perfessor (in this case, the young and vibrant Dr. Bob Goldberg) tells it like it is …

The study put out by the Democrat minority staff of the House Government Reform committee, “Medicare Drug Plan Prices Are Increasing Rapidly,” is misleading and inaccurate in many respects.

It deliberately leaves out drug plans that allow patients to pay a fixed low price for all the drugs they survey. There are many drug plans that allow consumers to pay $30 for a month’s supply of each drug (or $25 a month if purchased through mail order). All these prices are substantially lower than any of the average prices cited by the Democrat staff. For example, the Democrat House staff quotes average prices of about $150 for a month supply for Aricept and Advair whereas most plans quote about $27.

Nor does the study does control for different co-pays and prices for drugs depending on its tier placement. Zocor, Prevacid and Lipitor have been shifted into higher co-pay and price tier by some companies and not others. At the same time, some companies have pushed Celebrex off their formulary and raised prices accordingly while others have kept it on formulary.

Even when these errors and oversights are taken into account, a significant number of companies offer drug prices lower than those quoted by House Democrat staff. In many cases the prices quoted by the various plans are about 75 percent lower than the average price cited by the House Democrat staff.

Like Casey said, you can look it up.

No Joshing

  • 02.22.2006

I recently had the privilege of a private meeting with Nobel Laureate Joshua Lederberg. The topic of conversation was the future of the FDA and the agency’s Critical Path initiative. We talked about the state of applied research and “the texture” of the agency, the prioritization of development science, biomarkers and a host of other future-oriented issues. He talked. I took a lot of notes. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, “The real question should be, is innovation feasible?”

I hope so.

Smart thinking from Bob Goldberg, CMPI’s new Vice President for Strategic Initiatives …

Meet the challenge
By Robert Goldberg
Published February 21, 2006
The Washington Times

Democrats are gearing up to make health savings accounts and Medicare battering rams against the Republican Party in in the midterm Congressional elections. Liberal think tanks and congressional Democrats first attacked the Medicare drug benefit as a “a complex program that does nothing to bring down the costs of soaring drug costs.” Now, they are trashing health savings accounts as a tax shelter for the rich without offering an alternative of their own.

They don’t have to. The Bush administration and congressional Republicans have done a poor job responding to criticisms of the Medicare drug benefit and HSAs. Conservatives and think tanks have largely stood on the sidelines as the beating has taken place. Many think they are standing on principle, but in fact it reflects a lack of vision on their part.

The fact is, most conservative think tanks and conservatives frame Medicare and health insurance in terms of reducing health-care costs. As a result, they cede the moral high ground on the health-care issue that is all about coverage and quality of care. Similarly, as I have argued before, conservative griping about the cost of the Medicare drug benefit has blinded Republicans to the fact that Medicare modernization is counterweight to single payer health care.

Liberals complain that even if HSAs become the norm, they won’t slow health-care costs because 80 percent of all health-care spending is incurred after the high deductible ($2,100) is met and would still be generated by consumers using insurers’ money instead of HSAs. That’s true. Then again, the same thing is even more true about single-payer systems or managed care plans where the out-of-pocket cost are nearly hidden.

In either case, it’s the 20 percent of people with chronic illness that generates 80 percent of the cost. Medical progress, not administrative machinations, will reduce the cost of disease.

Conservatives are doomed to lose the HSA debate because they regard them largely as cost cutting tools. To the extent that anxiety about health care coverage is at the heart of uneasiness about a vibrant economy, it behooves the Republican Party to retool their health-care message in general and their HSAs policy in particular.

Republicans must commit to expanding and protecting medical insurance for all Americans. HSAs should be hailed as one way for achieving that goal. Last year, people with incomes of $35,000 or less per year were the fastest growing segment of HSA-eligible health insurance plan purchasers. Sales to this segment grew 104 percent over 2004. MIT economist Jonathan Gruber estimates that more than 1 million working class people will lose their insurance as a result of HSAs being offered. He doesn’t explain why. Maybe the 1.5 million lower-and middle-income people, who were previously without insurance were too stupid to follow an MIT economist’s theory. They actually obtained obtain insurance that included well baby visits, prescription drugs, ob-gyn care and other medical care for about $125 a month, less than what they paid last year.

To continue to boost and maintain insurance coverage among low and middle income Americans, the Republicans should introduce legislation that allows employers to put the full amount of the deductible into HSAs in order to eliminate any out of pocket cost. Working-class and poor families should receive pre-funded debit cards for HSAs with the full deductible amount as well.

The Department of Health and Human Services could help people comparison shop by posting Medicare prices for every single service. It could work with WebMd and other private health-information services to share news about who is doing a good job delivering medical care. Further, since most people rarely spend more than a small percentage of their account, the legislation should allow unused funds — as well as any additional monies contributed by the individual to be used tax free to pay for health care premiums during periods of unemployment as well as any deductibles or co-pays.

Third, HSAs must be compared to liberal efforts to prop up a single-payer and an employer-based health system that is providing less coverage for more money each year. Liberals are responsible for the loss of health care coverage in America. Now they shriek that HSAs would leave less money for subsidizing the increasingly expensive health insurance demands of labor unions, demands that send jobs overseas. Meanwhile, HSAs are giving more working class people more coverage they can keep and call their own for less money.

HSAs are not for everybody or a panacea. They’re only part of a long-term effort to expanding access to health insurance. But if Republicans frame the HSA debate in terms of coverage, they can stop playing defense on health care. First, they have to get passionate about the value of medicine and not what it costs.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest.

According to an article in today’s edition of The New York Times, psychiatrists say they have been getting panicked phone calls from patients worried by an FDA advisory panel’s recommendation this month that drugs for attention-deficit disorder carry a prominent warning about heart risks.

Can you say “unintended consequences?”

The calls are coming not just from parents of children who take the drugs but from adult users, who the panel warned might be at the highest risk for heart problems.

Can you say, “irresponsible advisory committee causing increased non-compliance?”

“Every single adult patient I saw today, the first thing out of their mouth was, ‘Am I going to drop dead on this?’ Every single one of them,” said Dr. Timothy Wilens, a psychiatrist at Massachusetts General Hospital in Boston.

Can you say “fear replacing caution?”

Can you say “Precautionary Principle?”

Because if you can’t say it, you can’t fight against it.

And fight against it we must.

WHO's Next?

  • 02.20.2006

The just completed WHO meeting on counterfeit prescription medicines is over. And what took place in Rome should have a chilling effect on us all.

Consider these few facts (direct from WHO, so nobody can say they’re “industry” numbers) —

Between 1998 and 2004 there has been a 1000% increase in seizures of counterfeit prescription drugs

That is not a typo. A 1000% increase.

Between 2001 and 2004 there were 170 official cases of counterfeit medicines originating from an illegitimate supply chain

And most frightening …

Between 2001 and 2004 there were 27 official cases of counterfeit medicines that originated from the legitimate supply chain.

Sound frightening? It is.

Action is required.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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