(FORTUNE Magazine) - Deadly Caution
"FIRST DO NO HARM" works pretty well unless it is carried to extremes ("Deadly Caution," Feb. 20). When the public is informed enough to appreciate the damage that can result from new drugs' not being approved expeditiously, the political aspects of the FDA's decision-making process will probably change to reflect that perspective. That calls for significant representation of patients on review panels, since their interests are necessarily different from those of others on the review panel.
A cost-effective program could also be instituted to capture better information on the effects of drugs after they have been approved and are on the market. That would reduce the risk for the FDA of okaying a drug, since it would tend to lower the extent of post-approval damage.
STEVE REED Lebanon, Ill.
YOUR STORY has merit in its premise that "our national obsession with drug safety is killing people"--especially as it applies to cancer drugs for terminally ill patients.
If you ever decide to do a story showing the flip side to your argument, psychiatric drugs are a good rock to look under. Quite a few bodies are buried there, and I truly wish the FDA had exercised the same caution in approving them that it apparently has in drugs to treat cancer.
If there is something wrong with the FDA's process for getting promising drugs to market quickly enough, certainly there is also something wrong with the oversight process--if such could even be said to exist--when approved drugs show serious side effects. Once a drug receives FDA approval, the chances of getting it taken off the market are very small, and the amount of data that must be submitted and reviewed to support its removal is enormous.
ERNEST RYAN Temperance, Mich.
For more on this subject, see David Stipp's "Trouble in Prozac Nation" in this issue.
Great Car, Iffy Marketing
THANKS FOR THE NICE PEEK at how Toyota keeps turning out good products and on the development of the Prius ( "How Toyota Does It," March 6). I own a 2004 Prius and have been happy that Toyota did what was needed--we could use some design thinking outside the box.
I continue to be struck by the marketing efforts that ignore what motivated me to buy a Prius. I have owned 105 cars since my first, at age 16 in 1938--a Dodge Sport Roadster, which had a starter-generator combined. I had learned to drive in a Model T with a planetary transmission. The Prius is related to those auto technologies.
Also, I had been irritated by all the cars with an unnecessarily large turning radius--all greater than the Prius's 34 feet. And the Prius, with a drag coefficient of .26, is reasonably quiet at 80 mph. You can only come close to that with a few Porsches.
JAMES LEE Athens, Ohio
EAMONN FINGLETON'S "Manufacturing Matters" (Dispatches, March 6) should be required reading for all CEOs of American corporations, all professors and students in MBA programs, and all national leaders.
Fingleton hits the nail on the head about the shortsightedness of American industry for not investing intensively to maintain the nation's manufacturing base, and consequently depending increasingly on imports.
Furthermore, American managers and national leaders have not yet incorporated into their strategic thinking the crucial need to look beyond the domestic market and to manufacture for export, a notion that is ingrained in the mindset of industrial countries with high per capita income and trade surpluses--Germany and Japan being leading examples.
Americans will have to double their exports just to match their level of imports. Meeting such a target would put exports over 20% of GDP. This challenge requires a worldwide perspective, government policies to encourage exports, and a commitment of America's corporations to invest in domestic research and manufacturing.
JACQUELINE BUGNION St. George, Switzerland
China Invests in Africa
CHINA'S INVESTMENT in my country, Nigeria, comes as no surprise ("China's African Safari," Feb. 20). As the largest black nation in the world, Nigeria has great potential as a consumer market.
President Olusegun Obasanjo has encouraged foreign investment since he came to power in 1999, and India, Indonesia, South Korea, and other emerging economies are already investing aggressively there.
I have studied my country's economic growth for 20 years (and am now a student of international investment at the University of Southern Illinois), and I believe that Nigeria is one of the greatest investment decisions China has ever made.
JIMMY TORIOLA Carbondale, Ill.
WHEN I WAS A CHILD, my granduncle used to tell me how in the early 20th century, during the final years of the empress dowager, people in Beijing were all afraid of Westerners. He would shout, "The whites are coming! Run and hide!" whenever he saw them on the streets. Times change. Now, armed with their newfound fortune, the Chinese are all over Africa looking for energy and bartering for trade. I wonder if the Africans are saying, "The Chinese are coming! Welcome! Welcome!"
Cameron Highlands, Malaysia
The "Good Science" Paradox
Clifton Leaf's "Deadly Caution" (Feb. 20)
exposes an unfortunate result of our risk-averse culture--namely, that the
regulatory process that seeks to protect patients may actually harm those most
seriously ill and without therapeutic alternatives. We draw false comfort from
a rigorous science-based approach to the evaluation of promising new drugs and
medical devices, but fail to recognize that those dying patients who are placed
in the control arm of the study are essentially condemned to death. That may be
an appropriate way to study life in petri dishes but is unethical when dealing
with human subjects. The FDA is caught up in a "good-science" paradox.
Its approach to clinical studies on deadly diseases and conditions favors
statistical purity over what may be best for desperately ill patients. And
those patients deserve better.
Fellow, American Institute of Medical and Biological Engineering
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