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New drug rules: life-saver or safety risk?

CARLY WEEKS

From Friday's Globe and Mail

Latest comment posted at 8:02 AM EDT 15/04/08

Experts divided over whether proposed system for approving and monitoring drugs will result in harm or benefit to Canadians ...Read the full article

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  1. S N from Toronto, Canada writes: It should help at least those folks who are dying to live so they may not have to regret later!
  2. JD Wood from Toronto, Canada writes: How can anyone seriously believe that these "safe and tested" drugs are ready to be used on humans. I have two words: THE PROFIT MOTIVE. If you want to find out why drug companies are making us sick and then producing "treatments" JUST FOLLOW THE MONEY!
  3. E M from Vancouver, Canada writes: I think everyone needs to remember that these drugs are made of chemicals. Chemicals that you're putting into your body.

    Most people think that "oh it's just allergy medication..." or whatever, it can't harm them.

    All these things can cause many problems.

    I once took too much allergy medication and suffered horrible side effects for a good week after I stopped taking the meds.

    Sometimes the side effects are worse than the symptoms.
  4. Ivo Cerckel from Siquijor, Philippines writes: At least three children have been born in Brazil in the past three years after their mothers took [thalidomide] while pregnant. There have also been reports of thalidomide defects from Mexico, India, and Africa.
    (Thalidomide: a curse and a blessing?
    By Clare Murphy
    Health reporter, BBC News
    Thursday, 3 April 2008 09:26 UK
    http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7326588.stm )

    Dishonest Drug
    April 6th, 2008 by ivo
    http://bphouse.com/blaze/honest_money/
  5. Ivo Cerckel from Siquijor, Philippines writes: CORRECTING THE SECOND URL
    http://bphouse.com/blaze/honest_money/2008/04/06/dishonest-drug/
  6. Wayne Spitzer from Faywood, United States writes: E M from Vancouver - did you know that food is just chemicals? In fact everything, both natural and man made are just chemicals. Some chemicals are good and some not so good; some natural chemicals will kill you and some man made chemicals can save your life. Nothing is absolute.
  7. K J from Toronto, Canada writes: Come on people. The problem with the general population is that they have a hard time accepting the fact that pharmaceutical companies need to be profitable. In times of economic hardship, would you want this industry to collapse? Absolutely not! Thanks to them, we now live longer and better lives. Think about it: aspirin, insulin, penicillin, lipitor, etc., etc., etc. My daughter owes her life to medications that these companies have produced and I am eternally grateful. I don't mind that they are profitable - as I stated, they NEED to be profitable so that they can continue to invest in R&D which grows more expensive each year. And Canada's health care system is fragile as it is - imagine if it were overloaded with sick people if there were no drugs available to help mitigate the problem? Health Canada is already one of the most conservative regulatory bodies in the world. We are always the last G8 nation to get medication. I welcome progressive licensing. Listen, if you don't want the drugs - don't take them. It's that simple. But if you are in need, then everyone must understand that no drug is perfect. We are all unique individuals and as such, some people will react adversly to drugs, whereas others will react with absolutely zero ill-effects. It's up the physician to make the call whether or not the patient should get a specific medication. Our agencies are already too restrictive - penicillin or tylenol would never be approved today under the new regulations but where would we be without these meds? Now extrapolate to how many new medications are potentially lost due to the media-inducing fear that precipitates over-regulation. Let's have some faith in our experts at Health Canada who do approve drugs. And let's challenge our physicians who are afraid of the latest medications. Don't forget - media only publishes negative stories when a drug kills someone. But where are the thousands of positive stories? Oh right, they don't sell.
  8. garlick toast from Canada writes: what is it about big pharma and the conservatives?bring on the generic manufacturers for existing drugs and save tax-payers millions of dollars.
  9. Stude Ham from Outremont, Canada writes: In a letter to the editor of the Toronto Star, health mini clement stated something to the effect that the druggies would themselves monitor the effects of their products.

    clement got his start in a provincial government that gave us the walkerton tragedy.

    this law is frightening... very frightening. this is conservative madness.
  10. Mark Orr from toronto, Canada writes: Drug regulation is excessive. They should allow drug companies to sell drugs that have not been approved as long as they are CLEARLY MARKED. People who want to do their own research and are willing to take the risk as well as foot the cost should be allow to do so.
  11. John Smith from Canada writes: KJ from toronto, I thought about it as you suggested. Insulin and penicillin were not the product of the pharamaceutical industry. Bad examples to make your case that profit drives innovation. The origins of aspirin are more in dispute but accepted consensus is that it was not the product of pharma innovation, it was researchers with Bayer jumping in and trying to steal credit. So again, your example of pharma innovation is wrong.

    As for lifestyle drugs like lipitor, its overall effectiveness is questionable and certainly should not be placed in the same class as penicillen and insulin in terms of powerful innovations.
  12. K J from Canada writes: Hey John Smith. Fair enough; however, there is an endless list I can delineate to prove the point. But also consider, penicillin and insulin would not be on the market today without the assistance of big pharma. Banting and Best deserve all the credit for insulin, but it was Eli Lilly that helped bring it to market for all to benefit from. It's not about who takes credit, it's about bring benchtop science to market fruition. At some point along the value chain or product life cycle, pharma helps. A lot of the academic research is only possible because of pharmaceutical funding. Without them, too many Canadian researchers would not have the funding necessary to advance the frontiers of science. So the point I was trying to make to begin with, is that health care and drug development still needs the pharma industry, no matter how small or big their involvement. Garlick toast: I agree there's a time and place for generics, but let the branded drugs recover their costs and then some before introducing generics. And did you know: generic companies by law only need to have 80% of the active pharmaceutical ingredient to the branded? And that the rest of the fillers can be whatever so long as efficacy is somewhat similar? There are hundreds of adverse events reported either in terms of side effects or lack of efficacy when patients on finely controlled medications are switched to their generic equivalents. In some cases it works, in others it doesn't. Again, the onus should rest on the qualified physician to make the call. Truth of the fact is, big pharma actually saves tax payers more money than generics despite contrary belief. But that's for another argument.
  13. Cecilia Belcastro from toronto, Canada writes: One of the main points in this article is that this type of regulation will mostly affect those IN DIRE NEED OF THERAPEUTIC RECOVERY. This does not go out to those who get the flu or have a common cold. I believe the reason America is lightyears ahead of us in terms of research and treatment is that they have laxed their regulations on medication. It is and always has been based on personal choice as to whether or not you receive the treatment, so I am all for the push for this policy.
  14. John Smith from Canada writes: KJ, I thought the issue you were raising was true innovation and break-through advances, not simple manufacturing and distribution. As has become embarrasingly obvious, much of pharma's r&d is in reality marketing. Very little of pharam's investments in academic research is related to early and exploratory development that leads to true innovation, and to say otherwise is to myth-make for the (paid?) benefit of this industry.

    And as we are now discovering with antibiotics (led prominantly by the non-pharma based break-trough of penicillin), pharma chose to mass market antibiotics to a level that now threatens their effectiveness. Pharma chose profit over humanity's health and well being.
  15. John Smith from Canada writes: What is missing from this article is any reasonable evidence that the current system has prevented the introduction of a break-through drugs or has actually cost lives in trying to balance safety with intervention. Oh right, because no such credible evidence has been introduced by lobbyists such as Pfizer Canada Inc., Roche Canada and BIOTECanada. Indeed, the bulk of evidence right now would indicate that the current bar for approval is set too low in approving new drugs with inadequate surveillence that in fact pose considerable safety risk. Pharma industry is not composed of humanitarian organizations and any suggestion they so desparately want this to help people (as opposed to profits) is nothing more than a lie. Vioxx anyone?
  16. larry hallatt from Canada writes: It is about time that experimental drugs are released faster and monitored to determinine long term affects and benefit. Anyone in severe pain, who have severe quality of life difficulties or are determined to be fast tracked terminal should be allowed to choose to try new medicines at their own expense or subsidized under an experimental test program. Good ruling.
  17. Expert Eel from OttaPettaOshawawawawa, Canada writes: Maybe the conservatives can create a loophole for big pharma to reintroduce thimerisol as a preservative in vaccines again
  18. K J from Canada writes: JS, you must certainly accept that some, not all, true innovation has indeed come from pharma. I definitely concede that not all innovation has come from them, but I grant them credit for what has. And they would be more than happy to endorse academic research much more so; however, they are prevented from doing so because of the perception of their involvement. As a result, academia suffers from further lack of funding. Academic institutions limit their involvement (disclosure: I'm in academia and would love to have full pharma funding but the powers that be limit the amount of funding I can accept from them, so instead I run a sub-par lab struggling for limited research dollars and hiring sub-par post-docs to meet budgetary limits). As for Vioxx my friend, Merch vountarily withdrew the medication DESPITE the FDA requesting it's continued availability. Merck did it as a public relations move which backfired. The public wanted it pulled, the doctors and scientists wanted it available. Who won? No-one. Whether the appropriate patient gets Vioxx or not is up to the physician, not pharma! And what about Merck's endless efforts to cure River Blindness in Africa??? No-one wanted to pay for the medication. Not the WHO, not the US, not the African governments, certainly not other NGOs. Thousands of lives saved thanks to Merck. Who paid for every single dollar of non-profitable investment? Merck. So, please JS, Vioxx may have led to some deaths (again, I feel a physician should be more accountable), but how many lives benefited from this medication? I was on it through knee-surgery. And how many lives saved from River Blindness? How many lost? Net result: positive. Listen, I'm not saying big pharma is completely innocent. There are still a lot of bad apples but let's not paint the entire industry with the same brush stroke. At the end of the day, drugs save more lives than they harm. When you drive a car, do you accept the risk 'may cause death'? We all do.
  19. John Smith from Canada writes: Fair enough KJ, pharma does produce some innovation. I would argue much less rather than more. The general output of innovation is mild tinkering with weak demonstrated benefits justifying cost of "new" drugs. It is well know a large chunk of what they call R&D is in fact marketing (a point you slide past despite the wealth of evidence indicating this to be an accurate statement). I would certainly hold physicians partially responsible for prescription, while pharma industry too often encourages utilization that generalizes use far beyond confines of clinical trial. They do so for profit, not better care. And the use of incentives for physicians to prescribe a drug and beyond the parameters of approval decision still remains a problem. It is more than a few bad apples. The point of this article is regarding how high the bar should be set for safety and ensuring effectiveness. The bar should be set high. To continue your methaphor, we do not let 3 year olds or 9 year olds drive. The current bar is adequate - the real issue is post-market surveillence (a poor system at best that does not lift my confidence in this possible decision). Bottom line is, no one has produced any credible evidence that the current system is unnecessarily delaying approval. They just use that PR line to persuade a gullible and uninformed public. If one wishes to increase risk to public, bring forward the credible evidence and leave the PR to liars anc crooks.
  20. Wayne Spitzer from Faywood, United States writes: John Smith from Canada - If your intent was to show that the pharmaceutical industry has not been innovative, both insulin and penicillin are among the very worst examples you could have possibly chosen to illustrate the point. While it is technically correct to say that neither was initially discovered by pharmeceutical companies, converting the initial discovery into a useful medical product required invovation of heroic proportions. You need to understand that the development of any useful drug absolutely requires two parts. Basic research (which often includes initial discoveries like the role of insulin in diabetes or that penicilln has antibacerial properties), and applied research - taking the initial knowledge and converting it into something useful. Pharmaceutical companies do not reqularly engage in basic research, but the implication that basic research is somehow superior or more important is completely wrong. Both basic research and applied are essential. Neither can survive without the other.
  21. John Smith from Canada writes: Quite simply, you are dead wrong Wayne Spitzer.
  22. Bert Russell Paradox, BC from Canada writes:
    The Pharmaceutical Industry is like the Oil Industry - they manipulate prices. My Doctor once gave me some good advice. Wait until a new medication is approved for two years before you become their guinea pig, because that is where and when the real testing and side affects become known.
    Now if I were dying of Terminal whatever and some new drug were promising I would go for it. Our media and particularly CTV participates in this so called wonder drug advertising to counter their bad negative news
    reports.
  23. Wayne Spitzer from Faywood, United States writes: John Smith from Canada - I have worked a
  24. Wayne Spitzer from Faywood, United States writes: John Smith from Canada - I have worked as a Ph.D. scientist in the field of medical research for 30 years. I hold half a dozen patents related to b-lactam antibiotics (penicillin to you). What are your credentials? The scientific work that was required to bring insulin and penicillin to their present levels as useful medicines was both massive and highly innovative. Their stories make fascinating reading if your interested.
  25. Andrew Toth from Oliver, BC, Canada writes:
    Medicine has made a better world. We are a fortunate lot, and we should not forget it. If it wasn't for the miracle of medicine, I would not be alive.

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