'Pharmaceuticals' Archive
Over the past couple of decades, the moderate intake of red wine has been touted as having benefits over health issues including cholesterol, heart disease, and cancer. In recent years, sharp biotechnologists have investigated the use of red wine in their pharmaceutical development efforts, and the results seem to point toward the possible emergence of a miracle drug.
Resveratrol, a chemical found in red wine, is being researched for a variety of ailments. One biotech development firm, Sirtris Pharmaceuticals, was snapped up by pharma bigwig GlaxoSmithKline (GSK) at an 84% premium earlier this year largely due to its resveratrol development programs, which aim to treat health conditions including diabetes, muscular disorders, and cancerous tumors.
A team of scientists in France (in partnership with Sirtris) is looking at resveratrol as a possible new weight loss therapy, a particularly poignant topic since sales of Sanofi-Aventis’ anti-obesity drug Acomplia were suspended in the EU market last month. However, all of the drug candidates under investigation are in early stages of research or clinical trials.
The general theory behind resveratrol is that the substance activates sirtuin enzymes — these enzymes are believed to trigger anti-aging properties and ward off degenerative diseases associated with aging. Which means that in addition to treating specific age-related diseases (in areas including metabolism, inflammation, neurology, and cardiology), resveratrol has the potential to increase patients’ overall life spans.
The potential benefits of drinking red wine regularly (again, in moderation) have also been increasingly studied in recent years. Studies conducted in 2008 have linked wine consumption to the prevention of lung cancer and liver disease. While I imagine that these benefits will continue to be debated for a long while (especially weighed against the general pitfalls of alcohol consumption), it will be interesting to see whether resveratrol pans out as a true blockbuster drug candidate. GSK has certainly placed its bet on the optimistic side, but drug development trials, burdened by regulatory scrutiny and high costs, often fail. From where I’m standing though, the natural process of grape fermentation looks beneficial and profitable in more ways than one.
As cash-strapped consumers these days are trading in Neiman Marcus for the discount stores, big pharmaceutical companies flush with cash are looking to spend some of that money on bargain-bin acquisitions. Several drugmaking giants have indicated their intentions to use the economic downturn to snap up smaller developers at cheap prices, especially tiny biotech companies that are struggling to find investors. Novo Nordisk and AstraZeneca both said last week that they’re slowing down their share buyback programs to focus on acquisitions. GlaxoSmithKline (GSK) made a similar announcement earlier in October.
On Big Pharma’s side, the logic behind these moves is apparent: Pharmaceutical companies are rich, with US companies alone sitting on something like $113 billion in cash. On the other hand, their pipelines have dried up and the massive amounts they’re spending on R&D just aren’t paying off. BusinessWeek sums it up thusly:
The industry burned through a record $59 billion in research and development money in 2007, according to the Pharmaceutical Research & Manufacturers of America. It has spent $213 billion since 2004, making it among the most profligate industries when it comes to R&D. The payoff for society was supposed to be a steady flow of products that would improve people’s lives and reduce the government’s health-care expenses. Instead, drug research productivity has been declining. Last year only 19 new drugs were approved in the U.S., and few of them were true breakthroughs.
The pharmaceutical industry has long looked to biotech and smaller traditional drug developers to liven up its own internal research efforts (see the AstraZeneca/MedImmune deal, for one such instance) but the urgency around consolidation has been ratcheted up by the current economic crisis, which is hurting biotech firms more than most.
Always a risky proposition, biotechs are having a tougher time than ever getting investors to bet on them. Virtually nobody can go public these days (Phenomix just withdrew its IPO in October), and private investment has declined sharply. As a result, biotech companies are folding (AtheroGenics), cutting back on their development programs (Maxygen), or — much to the delight of those cash-rich drugmaking giants — selling out cheaply. Avalon Pharmaceuticals, a struggling cancer drug developer, did just that when it agreed to sell itself to Clinical Data for $10 million in stock. Others — like GSK, AstraZeneca, and Novo Nordisk — are anxiously awaiting their chance to make just as good a deal.
The Centers for Disease Control (CDC) reported earlier this month that about 25% of teenage girls in the US have received at least one dose of Merck’s Gardasil vaccine, which is considered a fairly high success rate for a new vaccine. Gardasil gained FDA approval in 2006 for females between the ages of 9 and 26. However, sales of Gardasil have dropped in 2008 due to a variety of criticisms including cost, effectiveness, and potential side effects.
The vaccine is designed to ward off four out of six strains of human papillomavirus (HPV), which are believed to be a primary cause of cervical cancer, and requires three doses at a cost of about $120 per dose. While the CDC recommends the vaccine for girls 11-12 (as well as “catch up” vaccines up to age 26), health insurance companies don’t always cover vaccines, and Gardasil’s newness and cost have many women hesitating to receive the vaccine. State and government agencies that have mandated the vaccine for certain groups (such as immigrants and Texas teens) have also experienced a good level of backlash over requiring such a high-cost and highly debated vaccine.
Also at issue is whether the vaccine will prove to serve its purpose. Scientists wonder whether its effectiveness will wear off and require booster vaccines in later years. And while the vaccine is believed to be effective in preventing HPV, there is a good amount of speculation over whether a cancer prevention vaccine is even possible at this time.
As with all new vaccines and medicines, it is difficult to foresee what side effects could come to light over time. A CDC report released last week stated that, based on an evaluation of adverse event reports, Gardasil is safe to use and is effective against HPV. The report shows that serious events and deaths associated with use of the vaccine have largely been attributed to other causes. While the report is reassuring, the CDC’s continued monitoring of the vaccine is necessary as some side effects can remain undiscovered for years.
GlaxoSmithKline (GSK) also has a cervical cancer vaccine (Cervarix) on the market in other countries that is under FDA review for sales approval in the US. Whether the GSK vaccine has any success in the market partially depends on how much acceptance grows for the Gardasil vaccine. Merck itself has a lot riding on the vaccine’s success.
Whether the vaccine has any effect on cervical cancer infection rates can only be proven over time, but when it comes down to it, the vaccine’s apparent success at preventing HPV is a valuable health benefit on its own and makes it a viable candidate that women in the recommended age group should consider when weighing their health care options.
First the Bush administration gave us the doctrine of preemptive war. Now they want to give us the legal precedent of preemption. But they’re going to have to shout down the Journal of the American Medical Association before they can get their way.
Preemption refers to a legal argument stating that, in cases where people are harmed by defective drugs, federal law (that is, FDA approval of the products) preempts state laws governing drug safety. If preemption were the law of the land, consumers who suffer injury from harmful drugs would have no legal right to sue the pharmaceutical companies who made and sold them.
Next month, the Supreme Court will decide on the issue in the case of Wyeth vs. Levine, in which a woman is suing the drug company, claiming that improper labeling of a drug cost her part of her arm. In a parallel case involving medical devices made by Medtronic, the Court agreed with the preemption doctrine. Now, drugmakers everywhere are on pins and needles to see if they, too, can escape liability.
JAMA just published an editorial arguing against preemption, following the New England Journal of Medicine’s denunciation of the principle earlier this year. The Bush administration and the pharmaceutical lobbying group PhRMA both support preemption.
I will admit, there’s a certain obvious logic to the thinking behind preemption: If the FDA has already deemed a drug or medical device to be safe, why should a company be punished for selling it sometime down the road?
There are a couple of major problems with that theory, however. One is that the clinical trials the FDA bases its decisions on are largely short-term studies that provide no information on what a drug’s long-term side effects might be. Who is to be held responsible if a drug proves harmful over time? Second, those studies are conducted by the drugmakers themselves, and they’ve been known to withhold a piece or two of critical information from the public about a drug’s dangers.
One such recent case, involves Johnson & Johnson, who just this month settled a slew of cases involving its birth control patch Ortho Evra. The patch releases significantly more estrogen into the body than the birth control pill, something the company knew but at first failed to tell patients (its label has been revised several times since it was approved in 2002). The higher levels of estrogen increase a woman’s risk of blood clots and stroke; in the hundreds of lawsuits recently settled, some 4,000 women complained of injury from using the drug, mostly in the form of blood clots in the legs and lungs. Some of the lawsuits involved women who died.
If the drug companies have their way — and they look pretty likely to — those women and their families wouldn’t be allowed to have their day in court, and drug companies would have little reason not to withhold crucial safety data from the public or the FDA. The only thing that’s preempting is justice.
If you’ve been wondering what the hot new hangout for biopharmaceutical researchers is (and face it, who hasn’t?), here’s the scoop: According to BusinessWeek, scientists and executives are fleeing the biopharma industry for the trendier environs of “clean technology” — the catchall term for efforts to create products and processes that are less toxic and wasteful and more environmentally friendly. It includes efforts at green construction, as well as alternative energies such as water, wind, solar, and biofuel.
As venture funding of biotech companies has (maybe) reached its peak, clean technology seems to be taking its place, receiving $1.6 billion in venture funding in the first half of 2008. Federal and state governments are another big source of funding for clean tech companies: Biofuel developers Novozymes and Mascoma both received multi-million dollar grants just this week. And as biopharmaceutical companies lay off their researchers and other workers, those employees are “following the money” to clean technology firms.
Some similarities between the two sectors make that transition possible. On the management side, clean tech companies benefit from the experience of biopharma executives, who have dealt with the same challenges of long-term R&D cycles and the need for finding investors willing to finance often risky projects. On the scientific side, researchers at many clean tech firms are using the same biotech research techniques used by drug companies to investigate the workings of human and animal cells, but they’re transferring those methods to plant cells and other materials used in alternative energy research.
And so biopharma’s loss is clean technology’s gain. It remains to be seen, I suppose, what kind of effect the brain drain might have on biopharmaceutical development. But, in these days of high gas prices and ominous climate change, alternative energies might be just as welcome as the next miracle drug.