Latest Drugwonks' Blog

Many Canadian Internet pharmacies are quite open about the fact that they’re getting their southern-bound drug supply from the UK. No problem there, right? Na-ah.

The Royal Pharmaceutical Society of Great Britain (RBSGB) and the Medicines and Healthcare products Regulatory Agency (MHRA) have collaborated on new guidance for pharmacists which explains the causes and consequences of counterfeiting and provides pharmacists with practical advice on detecting and reporting suspected counterfeit medicines.

The guidance has been jointly developed by the Royal Pharmaceutical Society of Great Britain and the Medicines and Healthcare products Regulatory Agency following a meeting of the Society’s Practice Committee where the dangers of counterfeit medicines were debated.

Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines and are supplying them through the internet, often to unwitting patients. The guidance offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting the situation to the MHRA and ensuring immediate patient safety.

David Pruce, director of Practice and Quality at the RPSGB said, “Counterfeit medicines can be extremely dangerous. They may contain little or no active medicine, a totally different medicine or a toxic chemical. The RPSGB has teamed up with the MHRA to provide invaluable guidance for pharmacists, particularly on how to report instances of counterfeit medicine supply to the MHRA.”

The article by National Enquirer…I mean Philadelphia Inquirer writer Thomas Ginsberg “Donations tie drug firms and nonprofits; Many patient groups reveal few, if any, details on relationships with pharmaceutical donors.” is written like a big expose when in fact it is much ado about old news…. The organizations he writes about have been open about their funding for decades so what’s the big deal? As long as there is transparency — and there is — caveat emptor. Ginsberg tries to draw a nefarious connection between the funding and giving companies a pass on safety…which doesn’t exist. On the contrary, Ginsberg simply swallows whole cloth the assertions of some that ADHD are unsafe and misstates the risk of suicide (it’s suicidal thoughts or behavior)…and wonders why groups that push for access and destigmatization of mental illness wouldn’t spread panic about rare or even non-existent problems. As for transparency….Ginsberg fails to note that the David Oaks of Mindfreedom believes that mental illness has no biological basis and his organization has no problem linkking its website to Scientology funded operations…. I guess taking money from drug companies is worse than forming a coalition of the willing with Scientologists..bad not to disclose one but ok to gloss over the other, right Tommy boy?

It's Tool Time

  • 05.30.2006

In today’s edition of The Wall Street Journal, Scott Hensley reports on the issue of post-market safety studies (and the supposed tardiness thereof) …

… Some in Congress and a recent report by the Government Accountability Office have faulted the FDA for not being demanding or vigilant enough on post-market studies. One solution proposed by some critics would be to give the FDA the authority to order companies to perform such studies, something the agency can’t do routinely under current law.

But even when the FDA does ask for more data or requires additional studies of drugs approved on an express path, companies often don’t follow through, FDA data show. The agency can yank a drug from the market if manufacturers don’t follow through, but that almost never happens.

FDA Deputy Commissioner Scott Gottlieb defended the current approach and reiterated his view that the agency doesn’t need or want unilateral authority to impose such studies on companies. “I think we have the tools we need, but we need to make sure we’re using them effectively,” he said.

Here’s a link to the full article …

http://online.wsj.com/article/SB114894002957165658.html

According to the Financial Times, the WHO will “….start talks on a global plan of action for research on priority health needs in developing countries. The WHO will hope to encourage development of medicines neglected by private industry.

The WHOâs 192 member states approved a consensus resolution on Saturday establishing an intergovernmental working party to come up with a strategy and action plan within two years…..

The Calling the move a âbreakthroughâ, Médecins Sans Frontières, the medical humanitarian group, said it would ensure that patientsâ needs rather than profits drove innovation.

The WHO accord followed what health officials called a âmiraculousâ change of tack by the US, which had previously indicated strong opposition to any steps that might imply a weakening or sidestepping of the drug patenting system.

In return, developing countries led by Brazil and Kenya dropped demands for a binding research and development framework and explicit support for âopen accessâ and other models of promoting health research outside the patent system.

The global strategy will implement the recommendations of a report to the WHO last month by an independent commission..”

Translation: Jamie Love’s effort to impose a Soviet style R&D planning bureau funded by a global tas on countries has been destroyed. The framework for the future will be the report of the Commission on Intellectual Property and Public Health which has no mention of Jamie Love and his beloved R&D treaty….

His approach would have suffocated and stifled efforts to transfer technology to produce vaccines and drugs to developing countries and mired efforts to innovate in politics and bureaucratic infighting. I believe the current patent system is not suited to promoting the development of drugs for neglected disease just as it was not suited to promoting orphan drug development 25 years ago…..and we need to come up with a way to shift production and pricing to developing countries more quickly….but the Stalinist model promoted by Love would make it impossible…thank goodness the WHO is moving in a dramatically different direction, which including rejecting the R&D treaty.

Why do policymakers and the media continue to lump side deals to stall generic competition with the introduction of generic versions of medicines by the companies that developed the drugs in the first place. They are entirely different animals with different results. One action prevents consumers from obtaining generic medicines in a timely fashion. The latter action introduces a generic drug at a launch price cheaper than that introduced by a generic drug company with a 180 day market monopoly. Some generic firms are complaining that compettion from authorized generics are cutting into their profits. How about that.. the so-called authorized generic adds competition to the generic marketplace and drives down prices. Let’s remember that the name of the law that brought the generic industry into being is the Drug Price Competition & Patent Term Restoration Act not the Generic Drug Company Guaranteed Profit Act. What’s better for consumers in the long run? Studies by Ernst Berndt show that in the long run there is more generic competition and lower prices for consumers with authorized generics. When the media and generic drug lobbyists conflate suspicious stalling tactics with legal and consumer friendly market actions, neither the truth or the public health is served

By Tony Pugh
Knight Ridder Newspapers

WASHINGTON — The Medicare prescription drug benefit has been cursed for its failures and celebrated for its triumphs.

The program’s flaws and shortcomings were exposed early and often in the first few months after its January launch. However, recent news of lower-than-expected drug costs, patient satisfaction and a seemingly successful enrollment drive have given the program a new bounce that could help Republicans fend off future Democratic attacks.

The cost of the drug benefit has declined from a projected $737 billion over 10 years to $675 billion. Beneficiary premiums are averaging $25 a month, down from $37 in last July’s budget estimates. And the projected net cost to taxpayers for 2006 will be $30.5 billion, 20 percent less than an earlier estimate of $38.1 billion.

Here’s a link to the whole article …

http://www.miami.com/mld/miamiherald/news/nation/14667904.htm

Interesting that Sid Wolfe and Public Citizen oppose user fees on the grounds and wants the government pay for all clinical trial and drug application review work to insure objectivity but has no problem charging people for info on its “Worst Pills, Best Pills” website or for the book by the same name as part of it’s noble effort to keep people from unsafe and deadly drugs. You would think such a high-minded group dedicated to such humane purpose would make the website and book a freebie….or hand the project over to the FDA free of charge. It would make the scaremongering garbage any more reliable but at least it would make the increasingly irrelevant and repetitive Sid Vicious consistent for change.

Suzanne Sataline’s article “ADHD Study May Renew Debate” does a disservice to parents and patients everywhere dealing with ADHD by doing a poor job of placing the relative risks and benefits of medication for the illness in proper context. The study you cite fails to distinguish, for example, between different medications and between extended and regular release medications. Randomized clinical trials show that patients taking extended release stimulants are less likely to the ER than those using three times a daily formulations. Then too, the study ignores the fact that children with ADHD are more likely to use the ER than children without. Most troubling, you ignore the fact the the incidence of adverse events with such medications is extremely low compared to other widely used medications. For example, aspirin and other painkillers are associated with 117,000 hospitalizations and thousands of deaths each year. By comparison children diagnosed with ADHD are no more likely to be sent to the ER than children without the illness, a point your article fails to make. Ultimately Sataline’s article — and the study upon which it was based — was structured to scare, not inform.


“Based on what you know or have heard …”

58% of people in a new Wall Street Journal Online/Harris Interactive health-care poll (conducted online May 12-16) said that, “based on what you know or have heard,” the FDA does a fair or poor job ensuring the safety and efficacy of new prescription drugs, while 36% said the agency does a good or excellent job.

Based on what you know or have heard.

Two years ago, the numbers were reversed: then, 56% felt the FDA did a good or excellent job in the ensuring safety and efficacy of new prescription drugs, while 37% felt the agency did a fair or poor job in this regard.

Based on what you know or have heard.

Of 2,371 adults surveyed in the latest poll, 80% said they are somewhat or very concerned about the agency’s ability to make independent decisions that will ensure patients have access to safe and effective medicines.

Based on what you know or have heard.

The poll found that 82% feel the FDA’s decisions are influenced to some extent or a great extent by politics rather than medical science.

Based on what you know …

Most Americans don’t know the most basic things about what FDA is and what it does. And ignorance rarely evokes bliss. Most Americans think the FDA invents as well as regulates pharmaceuticals.

Or have heard …

What most Americans have heard over the past two years are false accusations, slanted half-truths, self-serving pronouncements, ad hominem attacks, vicious slander, and destructive score settling.

This is what some of our elected public officials hath wrought. And what have these same individuals done to improve matters?

(Pause for reflection)

I can’t think of anything either.

As George Bernard Shaw wrote,

“When a stupid man is doing something he is ashamed of, he always declares that it is his duty.”

For shame. And you know who you are.

According to Robert Pear “Democrats said they were counting on the doughnut hole to revive public criticism of the Medicare drug benefit, which has died down since March, when many of the initial problems were straightened out.”

“… Nancy Pelosi of California, has urged Democrats to hold town meetings and other events to keep up the drumbeat against the program, which she has decried as this disastrous Republican Medicare drug plan.”

The truth? Can Nancy Pelosi handle the truth?

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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