Latest Drugwonks' Blog

Here’s a press release from the Office of Senator Chuck Grassley which, along with the Senator, a edging towards a complete disconnect with reality when it comes to Ketek….

Sen. Chuck Grassley issued the comment below in response to the
announcement today about Ketek and a new bold warning label. Sen.
Grassley has been investigating allegations about the FDAâs handling of
Ketek and failure to ensure the integrity of a pivotal study about the
benefits and risks of this drug. The FDA continued to cite the study in
safety information despite its own determination that the study was
riddled with fraudulent information.

Grassley comment —-

âThere are questions about whether this drug should stay on the market,
and thereâs great legitimacy to those questions
. Ketek is another
example where the FDA accommodated a drug maker and turned a blind eye
to serious safety concerns. …..â

Is there anyone who questions whether Ketek should stay on the market? Who are they and what are there reasons? Does Senator Grassley have sources? And if he does, will he provide them or will we at drugwonks have to send someone over to his over to demand them?

We hope to have answers soon.

New op-ed, “Putting Clinical Trials in the Dock.”

Have a read:

Putting clinical trials in the dock
The Roanoke Times
June 27, 2006

BY: Peter Pitts

Pitts, a former Food and Drug Administration associate commissioner, is director of the Center for Medicine in the Public Interest.

“One size fits all” rarely does. From clothes to shoes to hats, few people find that items carrying that label work with their individual bodies. So why do we entrust the health of our bodies — one of the most important assets we have — to a one-size-fits-all mentality?

Unfortunatly, that’s exactly what the influential movement known as “evidence-based medicine” does. It sounds like a good thing, does’t it? Of course we want our health care based on evidence. But the phrase is misleading. As it turns out, “evidence-based medicine” often ignores the most critical evidence of all — the individual patient.

Advocates of EBM urge doctors to base their clinical decisions on research findings. Randomized clinical trials become crucial under this regime: The results of these trials are what doctors overwhelmingly base their suggested treatment on.

The problem is that clinical trials aren’t the only thing doctors need to take into account when making decisions. Evidence-based medicine emphasizes just one aspect of the clinical pie over all the others. This model, which began taking shape in the 1970s, is now broken and outdated.

EBM is stuck in the past. For the most part, it is a retrospective look at clinical studies and head-to-head comparisons of medicines and medical procedures. EBM may involve a careful look at the science. But in practice, it’s very limited. All of these studies are population-based, have rigid exclusion criteria and can’t integrate new information or innovations.

The result is decidedly and transparently a narrow one: to eliminate “practice variation.” Indeed, that’s one of the primary aims of EBM — to standardize medicine around what is known to work.

Practice variation is any treatment that varies from the norm that EBM prescribes. The canard of evidence-based medicine is the belief that practice variation is bad and that one-size-fits-all medicine is good. EBM presupposes that all people respond precisely the same way to all medicines. But that’s simply not true. Disease varies by individual, and selection of treatment must be driven by diagnostics, not just guidelines.

Today, the science of genomics is ushering in an age of personalized medicine. Clinical outcomes can be monitored with increasing precision. Computers can control for hundreds of variables to help doctors and researchers identify what treatment steps matter most in improving care.

People can be screened with a variety of molecular diagnostics to reduce side effects, increase compliance, improve outcomes, and even prevent various forms of cancer, depression, hypertension, Alzheimer’s and immune disorders.

This is 21st-century evidence-based medicine — patient-centric and cost-efficient.

The triumph of modern medicine is that it can be so precisely targeted to a single patient’s needs. It is a dramatic leap forward from EBM’s sweeping approach, which sees only through the broad lens of population-based studies, and the individual patient is kept out of focus.

Unfortunately, EBM continues to enjoy broad support in the policy community. Why? Because at its core, evidence-based medicine is cost-based rather than patient-based. In other words, its standardized approach supposedly saves money. But this is extremely short-sighted.

Evidence-based medicine may provide transitory savings in the short term, but the same patient who takes the cheapest available statin today may very well be the patient costing you — the taxpayer, the policymaker, the thought-leader, the sister, the spouse — big bucks when that patient ends up in the hospital because of improperly treated cardiovascular disease.

The repercussions of choosing short-term thinking over long-term results and cost-based medicine over patient-based are pernicious to both the public purse and the public health.

We need a new approach. The health care community must work together to develop new cost-efficient programs that account for modern genomics and individual screening. Because “one size fits all” treatments are dangerously outdated in this era of patient-centric medicine.


Generic Competition

  • 06.29.2006

Some people, like Senator Schumer, thinks it is wrong for drug companies to reduce their prices and co-market generic version of products nearing the end of patent life. As is Hatch-Waxman is a law that turns Para 4 challenges into an annuity. Sorry. That’s not what the law or the federal court says. And moreover, more competition means lower prices over the life cycle of the drug. As for the idea that Merck has “forced” managed care companies to impose a higher copay on generic Zocor, an allegation that Schumer served up, the fact is HMOs use higher copays to drive people to lower priced drugs all the time. I don’t like the practice because drug choice should be based on what’s best but that’s the game. Whining about it won’t change a thing and it shouldn’t.
Ultimately, the opposition to the Zocor price shift is just an effort to protect the generic drug “industry” and not consumers. It is ironic that the same people who belittle Rx and bio industry arguments about the impact of price controls on incentives for future investment are now arguing that the Zocor price shift and authorized generic movement —which is temporal and depends on blockbusters by the way — will undermine the long term incentive of generic companies to….initiatie patent challenges. What a loss. Fewer lawsuits.

Goodbye Delhi

  • 06.28.2006

The FDA has decided to shelve its plans of opening an Indian office to help expedite regulatory clearances for Indian drug exporters to US.

Sources said Dr David Lepay, the FDA’s Senior Advisor for Clinical Science and Director, GCP Programs revealed at a session on Asian clinical trials at the 42nd annual meeting of the Drug Information Association (DIA) in Philadelphia, USA, that the US food and drug regulator was not planning to set up offices neither in India or anywhere else in Asia, at present. The announcement from the FDA official came in the presence of Dr Ashwini Kumar, Drug Controller General of India (DCGI), who was also a speaker at the program.

Pharmabiz had reported about two years ago that the FDA was planning to start its Indian office at New Delhi with an initial investment of about $5 million, considering the fact that India has the maximum number of FDA-approved facilities outside the US. This office was to facilitate Indian companies with the procedures of filing for marketing approval for products to be launched in US, application for site inspection and other procedures dealing with the FDA. The office was envisaged to facilitate the exchange of communication between Indian companies and the US authorities, thereby saving a lot of time and resources, sources had told Pharmabiz.

Dr Leepay told the seminar, attended by a good contingent of Indian participants, that it was not mandatory that a new drug marketing application in the US be supported by a US study and there had been instances of marketing applications wholly supported by non-US studies. However, the FDA had criteria that non-US studies were expected to meet US standards and that non-US data was reviewed to the same standards as data from the US. Though the FDA had a long history of inspection of clinical trials outside the US, its experience in the Asia/Pacific region was limited, and the region currently accounts for only 5 per cent of FDA’s international inspections. He also clarified that the FDA does not certify clinical investigators, clinical sites, sponsors or ethics committees, nor does it approve study protocols or informed consent documents.

Here’s one of CMPI’s Scientific Adviser Peter Hotez, (and recipient of a Gates grant for his work on the development of a vaccine against hookworm) on how the Bill and Melinda Gates Foundation does it’s good work…

http://abcnews.go.com/Video/playerIndex?id=2121626

The latest broadside against the FDA is by Congressman Waxman who argues the FDA is doing a lousy job by not prosecuting and attacking companies who are producing inferior products, engaging in mislabeling or selling suspicious goods. This is the sort of after fact enforcement activity that pols love since it gives them something to hold hearing about. I call it regulation by body count since it requires people to die or be harmed in order for a regulatory or enforcement act to take place. In contrast, since Mark McClellan became commissioner in 2003, the FDA has sought to improve overall product quality through manufacturing efficiencies, risk management programs and other quality improvement efforts that are not politically sexy and often take years and millions of dollars to implement. (Not to mention cooperation. ) Indeed manufacturing is part of the Critical Path lest anyone forgets.

Of course, the drive by media ignores all of this. And the FDA has not done enough to get the message out about these important initiatives. One more thing: Why does Gardiner Harris refer to the ‘conservative’ American Enterprise Institute and the ‘watchdog’ Public Citizen? Public Citizen is nothing but ‘liberal’ and as for watchdog, that is a matter of opinion, not absolute truth. Even a Rockefeller can figure that one out.

Report: Many Americans Too Willing To Ask For Help
June 26, 2006 | The Onion, Issue 42*26

BETHESDA, MD — A National Institutes of Health study released Monday revealed that Americans are excessively, almost pathologically eager to seek help for various personal, psychological, financial, organizational, and sartorial problems. “American citizens are four times more likely to seek counseling than Canadian citizens, eight times more likely than the British, and 900 times more likely than Germans,” said the NIH’s Dr. Anne Hanratty, who authored the study. “In addition, they seek help an average of seven times faster than citizens of other nations, sometimes only a few hours after they undergo any emotion or experience that could be interpreted as negative or problematic.” A related study showed that Americans are nine times less likely to seek help for medical matters, such as high cholesterol or colon cancer screenings, but 85 times more likely to ask for second helpings.

At a time when the social scientists are telling us that post 9/11 Americans are more safety-conscious/risk-averse then ever before — while at the same time looking to medical science for ways to live longer, healthier lives at lower costs — the announcement that the FDA is going to lead the charge towards a 21st century model for clinical trials is good news — very good news.

Here’s the announcement. Further detail can be found at www.fda.gov.

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring

The Food and Drug Administration today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach to bioresearch monitoring as part of the Critical Path Initiative. The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.

The new effort is part of an HHS-wide initiative to employ recent advances in basic science, including genomics and molecular analysis, in order to bring about more effective development and review of therapies, and to enable increasingly targeted and individualized care management for patients.

“As clinical trials continue to evolve, in particular becoming increasingly large, decentralized and global, the FDA’s approach to bioresearch monitoring and human subject protection must also evolve and modernize,” said Janet Woodcock, FDA Deputy Commissioner for Operations at this year’s Drug Information Association annual meeting. “BIMO will help FDA modernize biomedical research monitoring making the most efficient use of its resources to help ensure the safe conduct of clinical trials, including taking appropriate opportunities to leverage existing oversight done by private entities to accomplish the Agency’s risk minimization goals.”

Clinical trials have evolved dramatically since FDA first began inspecting them in 1977. In an effort to protect the rights and welfare of human subjects and to verify the quality and integrity of data submitted for review, FDA established over time a bioresearch monitoring program that included the development and implementation of compliance programs to provide guidance for inspections of investigators, sponsors, contract research organizations, institutional review boards and bioequivalence facilities. With the expansion of clinical trial studies and sites, electronic record-keeping in the studies, and greater participation by vulnerable subjects in clinical trials, the role of FDA’s bioresearch monitoring compliance programs must expand and evolve as well. The HSP/BIMO Initiative addresses that need.

Over the past year and a half, FDA has carefully inventoried its programs and identified issues to launch the HSP/BIMO Initiative. As this initiative moves forward, FDA will continue to gather additional issues for the initiative and related information from internal and external stakeholders, e.g., industry, academic, and government activities and programs, and intends to conduct workshops and create other opportunities for public input.

Janet Woodcock, M.D., Deputy Commissioner for Operations, will chair the HSP/BIMO steering committee which is comprised of representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Food, Safety, and Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).


Caution needed in helping the FDA
By Boston Herald editorial staff
Sunday, June 25, 2006

The top Republican and Democratic members of the Senate committee dealing with health, Sens. Michael Enzi of Wyoming and our own Ted Kennedy, have begun preparing a bill that would give the Food and Drug Administration new powers over drug safety.

Some new powers are needed, but we fear Congress may go too far.

Senators are reacting to the withdrawal of Vioxx and similar drugs after the discovery that these stomach-friendly painkillers increased the risk of heart attack when taken for 18 months.

The FDA would get the ability to order changes in a drug label after it goes on sale and the power to force manufacturers to live up to any promises to conduct post-approval safety studies. Experience shows these are needed improvements.

But the bill reportedly (a text is not yet available) sets up dispute resolution procedures and requires the FDA to publish formal plans for evaluating and mitigating risks of every new drug, complete with schedules and timetables. All this would just augment the agency’s “avoid mistakes” culture. Its bureaucrats know they will be pilloried for approving a drug that later reveals problems, but will be left alone if overcaution delays the sale of something useful.

Caution has costs. Approval of Erbitux, a new treatment for colon cancer, was withheld in 2001 because not all the study patients had failed conventional therapy. The drug was approved 27 months later. Colon cancer strikes about 8,700 people every month; Erbitux (used with another drug) halts tumor growth for 4.1 months. The delay thus cost about 80,000 person-years of tumor arrest.

The FDA has improved its once-draggy performance. Average time to approval of new drugs fell from 22 months to 14 from 1993 to 2003; time to approval for promising drugs in fast-track review fell from 13 months to six. Congress should do nothing to slow it down.

Frank Lichtenberg of the Columbia Business School has estimated that on the average each new drug approved in 1970-1991 saved 11,200 person-years of life in 1991 alone, and presumably each year thereafter. New drugs yielded a return to society of 40 percent per year on the cost of development, he calculated.

All drugs have side effects. The senators would do well to encourage the taking of worthwhile risks, perhaps by mandating the use of sound cost-benefit analysis in surveillance of drug safety.

Great piece today in the NY Post by Dr. Marc Siegel about how the fearmongering by the media and certain members of Congress is driving his patients away from taking medicines that can keep them alive. Marc has written well about how we should use science — not fear — to guide policy and medical decisions.

Here’s the entire article:

POLARIZED PILLS
By MARC K. SIEGEL

June 23, 2006 — MEDICINES are too often portrayed as either life savers or killers - a polarization of our pills that serves neither science nor health care.

Thanks to two high-profile lawsuits, my patients are now asking me if Lipitor - the cholesterol-lowering drug - is still safe. With the suits claiming that Lipitor can cause brain and nerve damage, my old comeback - “I take the drug myself” - is no longer sufficient to calm fears. One patient tells me that I’m blindly ignoring the risks of serious side effects.

In fact, Lipitor, the country’s top-selling prescription drug, has been shown to prevent the progression of coronary plaques in patients with heart disease, and is likely to be as useful in patients who are at risk for heart attack and stroke from these same plaques.

The most potent drug in the class known as statins, Lipitor has been successfully administered to millions. In very rare cases, it can trigger a severe muscle breakdown known as rhabdomyalysis. It has never been proven to cause memory loss or nerve damage, and I and most other physicians believe it to be a safe and effective drug.

So why the worry? Part of the problem is the way the drug industry hypes its products, setting them up as some kind of panacea. But if it’s sold as a magic elixir, the discovery of any flaw rings alarm bells.

Not all drugs that are victims of the pendulum swing from panacea to panic are as famous or as successful as Lipitor. This month, an FDA safety panel also cancelled a study where 4,000 children were to receive the antibiotic Ketek, an effective treatment for bronchitis and sinus infections. Why stop the study? Ketek, a new drug, has been prescribed to over 5 million people over the past two years, but 12 have sustained liver failure (in four cases, fatally), while 23 others have suffered damaged livers.

Should Ketek be restricted, labeled with ominous warnings or taken off the market entirely? Not without much better evidence of danger. At a time when few new antibiotics are being developed, drug-resistant bacteria continue to emerge, drugs like Ketek are important tools.

Unfortunately, when the media and the lawyers target a drug, they overlook the fact that the side effects are rare, and/or alternative treatments more problematic. Sober statistics-based analysis gets tossed aside. The drug-maker’s stock price and the number of prescriptions written plummet.

Decisions on drug safety should be based on real facts - a weighing of the real risks and benefits. Hysteria doesn’t belong in the drug-safety equation.

Dr. Marc K. Siegel is an internist at NYU Medical Center and associate professor at the NYU School of Medicine.


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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