Laurie Burlingame
From Cyberlaw
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Putting all of my postings in one place
Interesting Articles
1. Top Selling Drugs of 2005
I just read this Article on Forbes.com and thought it was very interesting as it lists the top ten selling drugs of 2005. Pfizer's Lipitor is #1 at sales of $12.9 billion, now that is a serious amount of money. Also interesting is the fact that none of the drugs in the top 10 are products of biotech. companies. Enjoy the reading! Laurieburlingame 20:16, 22 March 2006 (EST)
From Forbes: The World's Ten Best-Selling Drugs Matthew Herper and Peter Kang 03.22.06, 6:00 AM ET
New York -
For the first time ever, global spending on prescription drugs has topped $600 billion, even as growth slowed in Europe and North America.
Worldwide sales of prescription medicines worldwide rose 7% to $602 billion, according to IMS health, a pharmaceutical information and consulting company. The United States still accounts for the lion's share of that, with $252 billion in annual sales, but sales in it and the other nine biggest markets grew by only 5.7%. But emerging markets such as China, Russia, South Korea and Mexico outpaced those markets, growing a whopping 81%.
"While these markets are a small part of the total marketplace, that's where the growth is expected to come from," says Murray Aitken, senior vice president of corporate strategy at IMS. Click here for a slide show of the top ten best-selling drugs.
Pfizer's (nyse: PFE - news - people ) cholesterol pill Lipitor remains the best-selling drug in the world for the fifth year in a row. Its annual sales were $12.9 billion, more than twice as much as its closest competitors: Plavix, the blood thinner from Bristol-Myers Squibb (nyse: BMY - news - people ) and Sanofi-Aventis; Nexium, the heartburn pill from AstraZeneca (nyse: AZN - news - people ); and Advair, the asthma inhaler from GlaxoSmithKline (nyse: GSK - news - people ).
One thing that's visibly lacking from the list of international bestsellers is a biotech drug. In the U.S., three anemia treatments, two from Amgen (nasdaq: AMGN - news - people ) and one from Johnson & Johnson (nyse: JNJ - news - people ), have cracked the top ten. But the biotech revolution brought by drugs made of protein that must be injected hasn't had quite the same impact worldwide, although the category still grew 17% to $53 billion. Most of the drugs on the list are small molecules, the same kind of chemicals, resembling German dyes, that kick-started the drug business into existence at the turn of the last century.
But right now, big drug companies are suffering from an innovation drought. Aitken says only 30 new medicines were launched in key markets in 2005, well off the peak of the 1990s. A more encouraging sign: There are 2,300 experimental drugs being tested in humans. In the late stages of human testing, IMS counts 96 cancer drugs, 51 heart treatments, 37 antivirals and 28 potential medicines for arthritis or pain. However, more and more drugs are being developed by biotech, though Aitken argues that this is less of a problem than people think.
"Let's not rewrite history in terms of where the innovations of ten years ago came from," Aitken says. Many of them, he notes, came from Japanese companies, like cholesterol pill Pravachol, or academia, like the cancer drug Taxol. Both of those became huge sellers for Bristol-Myers Squibb.
Another difficulty for big pharma: There are lots of $1 billion drugs but few mega-blockbusters. The second-biggest drug generates half as much revenue as Lipitor, and the tenth top-selling drug, Wyeth's (nyse: WYE - news - people ) anti-depressant Effexor, generates a "mere" $3.8 billion. That means even if new medicines are successful, they may not fill the holes created as drugs go generic.
That's one reason why Bristol and Sanofi were under pressure to reach a settlement in their Plavix patent dispute with generic drugmaker Apotex, announced late last night.
However, Aitken highlights the potential of several new medicines launched in the past year, including diabetes treatment Byetta, co-marketed by Eli Lilly (nyse: LLY - news - people ) and Amylin Pharmaceuticals (nasdaq: AMLN - news - people ), and Lunesta, an insomnia drug made by Sepracor (nasdaq: SEPR - news - people ). And there are more on the way that he says are worth watching. The two key drug launches this year are of Sutent, Pfizer's first big entry into cancer drugs, and Acomplia, the anti-obesity pill being developed by Sanofi-Aventis.
Sutent is already on the market, although sales data are not yet available. Acomplia has been delayed at the U.S. Food and Drug Administration and rejected as a stop-smoking drug. Some cardiologists, who are excited about the drug because of its potential to reduce the risk of heart disease, are also worried about side effects.
Acomplia works by blocking the same brain receptor that makes pot smokers hungry; psychiatric symptoms like anxiety are one of the most common reasons patients stopped taking Acomplia in clinical trials. "It's a pill that blocks the 'happy receptor,' " says Prediman K. Shah of Cedars Sinai Medical Center. "The main reason for concern is that it might have an adverse impact on depression or suicide." He is nonetheless very excited about the pill.
2. FDA and Phase 4 Studies
Laurieburlingame 20:19, 6 March 2006 (EST) I found this article today as I was purusing the latest in biotech news and I thought it was pretty interesting so am posting for all to read. Although there is obviously a lot of detail missing here regarding the overall importance of the studies that are not yet completed, it is kind of interesting to realize that this large number of post-marketing studies remain uncompleted, especially considering that this is the trade-off that companies have bargained for in obtaining expedited drug approval.
FDA Says Too Many Drug Studies Delayed Friday March 3, 7:26 pm ET By Andrew Bridges, Associated Press Writer FDA Says Drug Companies Leave Many Required Studies Pending After Medicines Are on Ma rket
WASHINGTON (AP) -- Drug companies sometimes are allowed to hurry medicines to market in exchange for a promise to continue studying their safety and effectiveness. Those studies haven't begun in two-thirds of cases, the government reported Friday.
ADVERTISEMENT The Food and Drug Administration said Friday that drug companies had pledged to conduct 1,231 drug studies. But as of Sept. 30, 797 -- or 65 percent -- were still pending.
"That doesn't mean they will never be started," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
Dr. Alastair Wood, associate dean of Vanderbilt Medical School, said if the FDA doesn't require the studies to be done, it shouldn't ask for them in the first place.
"It's astonishing, really. Their job is to get the studies done and not be an apologist for their not getting done," Wood said.
Federal regulators often grant new drugs expedited approval on condition that their manufacturers then carry out so-called "post-marketing" studies. The outcome of those studies can lead to changes in how a drug is made, prescribed and used.
Of the 797 studies still pending, commitments for 116 of them were made during the previous year. The clinical trials required under the commitments can take six months to a year to design and launch, Jenkins said.
Some studies had been agreed to years earlier, but the FDA didn't provide a breakdown.
The pending studies represent a slight dip from the 812 still pending as of a year earlier, according to FDA documents. FDA spokeswoman Kathleen Quinn said the agency feels that "these numbers show drug companies are taking this thing seriously."
Alan Goldhammer, of the Pharmaceutical Research and Manufacturers of America, an industry group, said the figures should not be "distorted."
"To be clear, pending does not mean delayed. It does mean, however, that the immense and vitally important tasks of developing research protocols, finding investigators and researchers and even recruiting patients to participate in the study is in process," Goldhammer said.
Dr. Jerry Avorn, a Harvard Medical School professor and author of "Powerful Medicines," in which he criticizes the FDA's post-marketing system, said the numbers show the system is broken.
"This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet," Avorn said.
The FDA says it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The FDA also can require the studies after it has approved a drug, including to better determine its safe use in children.
The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as delayed and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.
The report also tallies studies required of biological products, which include vaccines, blood components and transplant tissues. There, of 321 study commitments, 118 -- or 37 percent -- remained pending as of Sept. 30. Another 56 were completed by that date.
"The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug -- an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion," said Peter Lurie, deputy director of the watchdog group Public Citizen's Health Research Group.
Sen. Charles Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., introduced legislation last year that would give the FDA added authority to require drug companies to carry out studies of their drugs once they've been approved and are being sold.
The FDA plans to award a contract in coming weeks to evaluate and improve the process of how the studies are developed and implemented, Quinn said.
Other Postings
1) Clinical Trials
Laurieburlingame 10:46, 16 February 2006 (EST)
Although I haven’t yet watched the show on Outsourcing Clinical Research that Gary sent us, I wanted to suggest the movie- Constant Gardener to anyone in the class who has not yet seen it. This movie portrays a case in which a large US pharmaceutical company performs clinical research in a poor African country. The individuals who are given the test drug are not even informed that they are receiving it, i.e. there is no consent at all let alone informed consent. Unfortunately, several people die as a result of taking this drug. The government knows all about these trials and the associated deaths, but are more than willing to let them continue because if they did not allow the trials, many individuals would be without any form of health care as the companies also provided basic health care services to the region. Hence, it appears as though the government was employing a utilitarian calculus. I found the movie disturbing, but it does raise many interesting issues, so I would highly recommend it to the class.
Summary of Outsourcing Clinical Trials to India Video Clip
I thought I would just summarize the pros and cons associated with outsourcing clinical research that were mentioned in the video clip of India. I’m sure that there are others that were not explored in the clip and I’m not sure that we would necessarily place them in the same categories, but I thought it would be interesting to at least lay them out as a starting point for debate.
On the pro side, the Indian physicians noted that this gave them an opportunity for new learning and improvement of their clinical skills. Also, the physicians noted that they were able to spend more time with patients enrolled in the clinical trials (if patients are not enrolled in the trials, they get 3-4 minutes of the physicians time/visit), which could lead to better health outcomes for the patients. Interestingly, there was the suggestion that India had a better test population because a) the large population size and b) fact that most of the individuals were not currently on any other forms of medication due to lack of health coverage. Finally, officials noted that trials could be completed in less time in India due to less strict regulations (of course this can also be viewed as a con but the overall tenor of the clip was quite positive).
On the con side, there was fear that the patients would lie about their health status so that they could obtain access to health care by enrolling in the clinical trials. Then, there was the fear that the poorest individuals in the world were being used to test drugs that they would no longer have access to once the clinical trials were over due to high drug costs. Hence, the poor are taking all of the risks associated with clinical trials, while the benefits are being reaped by individuals in more wealthy nations.
As mentioned above, the clip seemed to portray this development as a positive one, at least when viewed from the point of view of the Indian government and health care workers. Although they did mention that the Indian government was imposing some safety checks into the trials, they did not mention if these checks would be as rigid as those imposed by the FDA. However, if the companies hope to have these drugs eventually cleared for the US market, it seems as though they would need to adhere to FDA standards, but I'm not at all sure about this. Does anybody have any thoughts about that? Laurieburlingame 08:51, 20 February 2006 (EST)
2) Ethics in General
I read an article in the Washington Post the other day regarding companies hiring ethics committees to review their internal procedures, the goal of which was to obtain ethical clearances for their operating procedures. In this article, I came across what I felt was a very interetsing quote from an individual that invests in biotech. companies. He stated: “There is, I think, a misunderstanding that if you set up an ethics panel there are some sorts of ground rules, like principles of accounting, and everyone knows what those rules are. In the field of ethics, there are no ground rules. . . . It all depends on who you pick." Therefore, he was arguing that companies can essentially buy ethical support for all sorts of positions that they take. This seems as though it can apply more broadly, for example, to the President's Council on Bioethics. What do people think about this quote? Do we need to develop more nuanced rules for bioethics? If so, how would such rules be articulated? How would we determine if they were being adhered to? Laurieburlingame 09:06, 20 February 2006 (EST)
- [NOTE: Here's the full text of the article to which Laurie refers -- Gary]
- I think the concern that companies (or government bodies or research institutions or even individuals) can cherry-pick arguments/advocates that support their desired position or outcome is a very real one. It's certainly not limited to bioethics but it is particularly problematic for bioethics (ethics in general I suppose) because, as Laurie/the Washington Post says, there aren't any ground rules. I know there have been attempts to establish such ground rules, and to pursue other lines of action designed to standardize and legitimize these bioethical panel recommendations (such as developing some sort of bioethicist accreditation program) but I'm not sure that any of them have been all that successful. Although I think that developing standardized guidelines is generally a good idea I'm somewhat skeptical that there are any universal rules of ethics that will be specific enough to really inhibit the production of agenda- or viewpoint-motivated ethical recommendations. I think that if there is a solution to be found it probably lies in forcing both the ethicists and their employers (companies or otherwise) to be far more open about their relationships with each other, including any possible conflicts of interest. DVorhaus 14:50, 20 February 2006 (EST)
- I think that my colleague makes a very good point about the need to have greater disclosure and increased transparency regarding the conflicts of interest that exist between potential ethics panels and the companies that are sponsoring/funding the panel. I know that in light of some of the recent fears regarding funded-research, some journals have mandated disclosure of the funding sources so that individuals can tell if such research is truly independent. Since I also think it would be very difficult to develop bioethics standards per se, at least aside from settting some baseline rules, I wonder if it would be possible to require multiple groups of bioethicists to review the conclusions of company-sponsored bioethics reviews? Of course the difficulty here is deciding where these outside reviewers would come from and what their review would be based on. Laurieburlingame 14:51, 23 February 2006 (EST)
3) GTC and lack of FDA approval
In relation to the article that Gary sent us last week regarding the major decline in the value of GTC Biotherapeutics when the European regulators failed to approve their novel drug for use in humans: I was wondering if anyone knew how much weight other regulatory authories, ex: FDA, give to refusals by other regulatory authorities? And if a great deal of weight is granted to these refusals, how much more research would need to be done to have a realistic chance of being approved next time around?
The case of GTC Biotherapeutics is particularly interesting to me because the facility where the goats are kept is in my hometown of Charlton, MA, which I believe the article refers to as "very rural." The facility is quite amazing and my friend actually worked there for several summers. Laurieburlingame 15:20, 27 February 2006 (EST)
4) Tranhumanist Approach to Genetic Enhancements
I think the transhumanist article than Gray posted made some good points regarding genetic enhancements. For example, I agree with the notion that genetic enhancements could have as many or more positive benefits than negative effects. I also thought their suggestion that it might be much easier to eradicate a diseased genome than to make an already OK genome even better was very insightful and seems highly plausible.
- The transhumanists also seem to contemplate the potential downsides to their stance. However, this approach can be as easily criticized as the Sandel position. For example, they state that future generations could easily revert the enhanced genome if they do not like what they see, but is this really plausible? Assume for example, that we figure out how to eliminate a certain trait, if this trait has never been in the future population and they have never experienced it, how would they ever know that they missed it and therefore wanted to revert back? Therefore, it seems as though reversion is less likely than the transhumanists suggest.
- Also, they fail to appreciate the potential that eliminating one trait might have on other traits. For example, it is possible that individuals deficient in one trait compensate by being better in other traits, for example like blind people generally have enhanced non-sight senses. In addition, perhaps there are some diseased states that lead to certain characteristics that are beneficial for human survival. Therefore, if these diseased states are eradicated, the traits associated with them will also disappear.
- Finally, their argument also suffers line-drawing problems, for example when they discuss promoting changes that lead to positive externalities versus those than lead to negative externalities. Who gets to decide whether a given effect is positive or negative? And would we really be able to measure subtle differences?
Personally I’m not opposed to genetic enhancements, but that might be because I think science is far away from performing genetic enhancements that people consider very scary. In addition, it is important to note that nature is improving the genome constantly through the process of natural selection. This improvement allows organisms to better adapt to their environments, but it takes many years to observe. Therefore, improvement of the species seems to be a pre-programmed process.
