| Editorial: Drugmakers: Optimized for Failure?
This is the title of a Perspectives article appearing in Pharma DD: Tracking Discovery and Development, July/August 2006. The author, Nat Goodman, states that "Drug development looks increasingly like an ecosystem on the verge of collapse."
The article goes on to describe that the low hanging fruit has all but disappeared, doctors and patients no longer see new market entries as miracle drugs and third-party payers no longer see newer, less-expensive drugs replacing expensive medical procedures and hospital stays. Formerly the drug companies were viewed as saviors, profits were strong, jobs were secure but that has changed. Pharma companies are no longer the "good guys in white hats," and are already looking "outside the box" for new solutions.
The rest of his article discusses the trouble with clinical trials that we all have come to place a lot of faith in. Is that faith misplaced? In some instances, probably so. Dr. Goodman calls clinical trials an irrational process, and he makes some very good points.
First, you take a group of people with a certain disease, give them the new drug and others an old drug or placebo, then sit back and wait to see what happens. When the study ends, you give the data to statisticians to do their magic and then declare the new drug as "safe and effective," if the computed benefit reaches the threshold of 95% significance. The paperwork is filed and evaluated, and a new drug comes on the market. In some cases, a few years later it's pulled from the market or receives additional labeling requirements known as "black boxes," as more clinical experience is gained from administration to more patients with multiple problems and medication interactions.
Anyway, back to the article. As described, the problems involve the following. First, most trials do not enroll all-comers; the old, the young, those who are too sick, and those who are too healthy are excluded and emphasis is placed on enrolling patients that are sick enough to show benefit but have no extraneous risk factors. This bears no relationship to reality in clinical medicine. Second, statistical rigor is almost always compromised by dropouts. When a subject drops out, there is no real way of determining what effect the missing data will have and no justification for assuming it affects all arms of the study identically. Finally, most clinical trials are of relatively short duration and, consequently, cannot assess long-term benefit and risk.
Not really addressed in our current system is the patient that has a serious, untreatable illness that will reasonably accept a greater risk and cost. They are denied drugs that may help them because of the structure of the current regulatory system. Someone dying of cancer that has gone through all the "approved" treatments may be willing to accept an experimental, unapproved drug, if they had access to it.
Let's ponder the changes in the approaches to pain management over the past 5 to 10 years. What is common today was almost unheard of 10 years ago, but has evolved through clinicians and pharmacists and not through regulatory agencies, which actually opposed much of today's common practices even though it is better for the patient. In fact, some physicians and pharmacists were the subject of intense and financially costly investigations by state and federal agencies for legitimately using large quantities of analgesics for their patients. We now know that it may take a lot of medication and the combination of several pain medications to control acute and chronic pain in patients.
As Dr. Goodman states, "�the correct efficacy threshold must vary as a function of risk and benefit and may be a matter of personal judgment." This approach is not dependent upon how a drug works universally in most patients, but rather is the drug likely to work in a specific patient. Information is needed that will help determine when to start a treatment, when to stop it and how to tell if a drug is efficacious and what are its side effects.
Maybe, just maybe, pharmacogenomics will play a major role here, and we will consider other options besides just historical procedures called clinical trials. As you well know, pharmacogenomics is personalized medicine and compounding pharmacy is involved with preparing individualized medications. I think the future holds great promise for compounding pharmacy!
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief |
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This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.
U.S. Food and Drug Administration (FDA) Issues Alert on Bismacine, Chromacine
FDA recently issued an alert on bismacine (also known as chromacine), an injectable product sometimes used to treat Lyme disease. There have been two recent adverse events associated with use of the preparation, which appears to require compounding by pharmacists. To read the full alert, visit www.fda.gov/bbs/topics/NEWS/2006/NEW01415.html
IACP Responds to Wyeth
The International Academy of Compounding Pharmacists (IACP) filed another round of comments in response to Wyeth's supplemental comments to their original Citizens Petition. Wyeth's supplemental comments were filed in an attempt to rebut many of the comments filed by compounding proponents on the FDA Docket. In our filing, IACP reasserts the flaws in Wyeth's petition that asks FDA to enforce elements of the federal Food, Drug and Cosmetic Act new drug approval requirements against compounded medications. Read a full version of the response (.pdf) at http://iacprx.convio.net/site/R?i=JBQY8taTcTR7qUwqxQ-tyg..
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Part 2 of our search for articles on alopecia treatments has added 38 abstracts on the subject to our CompoundingToday.com drug information database along with 13 abstracts on nonhormonal treatment of hot flashes (featuring gabapentin). Here is a sampling:
Guidelines for the management of alopecia areata.
MacDonald Hull SP, Wood ML, Hutchinson PE et al; British Association of Dermatologists. Br J Dermatol 2003; 149(4): 692-699.
Seventeen cases of alopecia areata: Combination of SADBE topical immunotherapy with other therapies.
Morita K, Nakamura M, Nagamachi M et al. J Dermatol 2002; 29(10): 661-664.
Management of hair loss.
Ross EK, Shapiro J. Dermatol Clin 2005; 23(2): 227-243.
Treatment of female pattern hair loss with oral antiandrogens.
Sinclair R, Wewerinke M, Jolley D. Br J Dermatol 2005; 152(3): 466-473.
Gabapentin, estrogen, and placebo for treating hot flushes: A randomized controlled trial.
Reddy SY, Warner H, Guttuso T Jr et al. Obstet Gynecol 2006; 108(1): 41-48.
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Two-Day Seminar Helping You Develop A Quality Compounding Practice That Meets and Exceeds USP Standards
When: September 16 & 17, 2006
Where: PHF Conference Center, 655 Research Parkway, Oklahoma City, Oklahoma 73104
Featured Speakers: Thomas Kupiec, PhD; Loyd V. Allen, Jr., PhD, RPh; and Kenneth R. Baker, RPh, JD
Click Here for more Information: www.spectrumrx.com/SpectrumRx/events/QAseminar.asp
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