Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Monday, September 15, 2014

The Marketing of Drug Wars

"These are not scientific issues, these are market-driven issues."
"Unfortunately, the victim is the 80-year-old woman who needs her blood-pressure medication, or arthritis medication and is subject to all this propaganda.... It's fear-mongering."
Fakhreddin Jamali, pharmaceutical sciences professor, University of Alberta

"[Those attacking generics .. are] undermining the system that Health Canada and the provincial regulators have put in place."
Jim Keon, head, Canadian Generic Pharmaceutical Association

"In most cases, there are differences in both inactive and active ingredients that may or may not be relevant for a particular patient."
"Patients should be empowered to choose the medication that best meets their needs."
Vincent Lamoureux, Pfizer Canada spokesman

Generic drugs are approved based on the scale of "bioequivalence" studies. Study groups are allotted either the original formula (Big Pharma) or the (generic, less expensive) copy The proviso is that the active ingredient in the generic drug must be detectable in the subjects' bloodstream reflecting a certain range of the brand drug. Critics of generic 'copy' drugs, less expensive than the original formula drug claim the generics may contain variations that can be problematic.

Some university-affiliated experts say that for the larger majority of medications that range is a non-issue. When brand-name-producing corporations produce their own generics or they decide to move production to another plant they themselves make use of similar bioequivalence tests to obtain the approval required from federal authorities for them to proceed under government-approved auspices.

Big Pharma make hefty investments in medical science to find drug combinations that work in alleviating the symptoms of various health issues. They seek a return on those investments by pumping up the retail costs to the consuming public. They first embark on a mission to advertise the presumed sterling properties inherent in the drug as a protocol for ameliorating a health condition to convince the medical community and patients alike of the need to use them.

And they make an impression in the gullible public through persuading medical professionals to use their singular products and to convince their patients that their use represents best medical practise preferentially to enable them to sweep the market and collect the profits they deem themselves entitled to. When their trademark monopoly on their formula has run its course, this is when the generic drug manufacturers step forward and lawfully produce their own versions to market.

Between 2010 and August of 2013, brand name drugs whose sales total $6-billion annually in Canada lost their patent protection and witnessed the resulting drop in sales as generics stepped in to produce much less expensive knock-offs of the original product. An increasing number of medical insurance companies managing private workplace drug plans look for less costly ways to run their business and generic drugs represent a substantial cost-saving, one used commonly by government drug plans.

"The doctors understand the differences and its the doctors who are actually raising this issue. The treatments are becoming so specific ... that the generics are not responding in kind, they're not being as effective in smaller patient populations", charged Gordon Polk of Mapol Inc. Yet according to Dr. Laszlo Endrenyi, a University of Toronto pharmacologist specializing in bioequivalence, the only exceptions remain a small group of medications such as anti-epilepsy treatments and the blood thinner Warfarin where insignificant alterations can become significant in their impact.

None of which has stopped the major name-brand pharmaceutical firms in mounting public relations efforts through conferences, paid studies, television appearances of physicians who allow themselves to be used as spokespersons for the industry and who have no hesitation in claiming that generics are not quite as reliable as brand-name products. The ordinary patient-consumer hasn't the scientific background to balance these charges, and nor does the average doctor.
  • An article in the magazine Moods that was funded and distributed to 11,000 doctors by Lundbeck, manufacturer among other products of the anti-depressant Cipralex argued that fillers in generic drugs can cause side effects which "may require additional medications" to treat.
  • A seminar conducted early this year organized by Mapol, funded by Astelas Pharma, suggested generic versions of transplant anti-rejection medicines might "increase the risk of poor outcomes."
  • A report from Ottawa and from Montreal university professors, funded by Valeant, charged Health Canada's bioequivalence standards are too broad, that patients prescribed the generic version of Valeant's anti-depressant could risk serious setbacks.
Big Pharma doesn't take kindly to the wholesale diminution of their profit margin. Their attacks, though having little or no basis in actual fact, shunted aside as garbage by 50 years of reliable use of generic drugs, they figure that planting the little seed of suspicious concern over generics may profit them big time, in the end; that niggling little worry in the minds of conflicted doctors, of their dependent patients.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.
An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is Lopressor.
Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.
Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect.

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